key: cord-0726369-u2hhef44 authors: Tandon, Nikhil; Gupta, Yashdeep; Kapoor, Deksha; Lakshmi, Josyula K.; Praveen, Devarsetty; Bhattacharya, Amritendu; Billot, Laurent; Naheed, Aliya; de Silva, Asita; Gupta, Ishita; Farzana, Noshin; John, Renu; Ajanthan, Saumiyah; Divakar, Hema; Bhatla, Neerja; Desai, Ankush; Pathmeswaran, Arunasalam; Prabhakaran, Dorairaj; Joshi, Rohina; Jan, Stephen; Teede, Helena; Zoungas, Sophia; Patel, Anushka title: Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial date: 2022-03-02 journal: JAMA Netw Open DOI: 10.1001/jamanetworkopen.2022.0773 sha: d2716a554ba86a268685274c6ce5f5f2616e3925 doc_id: 726369 cord_uid: u2hhef44 IMPORTANCE: Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. OBJECTIVE: To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. DESIGN, SETTING, AND PARTICIPANTS: This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. INTERVENTIONS: A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. MAIN OUTCOMES AND MEASURES: The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. RESULTS: A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76–1.12]; P = .42) or improve any secondary outcome. CONCLUSIONS AND RELEVANCE: This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals. TRIAL REGISTRATION: Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939 A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus Version 6.0 dated May 13, 2020 A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus. Women with gestational diabetes mellitus (GDM) are at high risk of subsequent development of type 2 diabetes mellitus (T2DM), particularly in South Asia, where the prevalence of GDM is rising sharply. It is uncertain whether a behavioural modification program tailored towards young women changing risk-related behaviour will prevent or delay the onset of T2DM. An open-label parallel group pragmatic individual randomised controlled trial with blinded primary endpoint adjudication. The randomised controlled trial will be preceded by an intervention development and optimisation phase. Low intensity lifestyle modification program Number of participants 1414 women with prior GDM from a total of 24 hospitals in Bangladesh, India and Sri Lanka. Duration 60 months Outcomes Primary outcomes: Proportion of women with a change of glycaemic category, at or prior to final visit: Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM; IFG or IGT to T2DM Secondary outcomes: Body weight, waist circumference, systolic blood pressure, fasting blood glucose, physical activity level and diet Inclusion criteria Absence of T2DM at 3 to 18 months post-partum OGTT Confirmed case of Type 2 Diabetes Travel time to hospital more than 2 hours (unless individual circumstances will not impede hospital attendance for study visits) Lack of access to a mobile telephone Use of steroids during pregnancy other than for lung maturation of the baby Likelihood of moving residence in the next 3 years Study schedule Jan 2016-Jan 2021 Sample size calculation -1414 women with GDM from 24 hospitals (~60/hospital) will provide approximately 90% power (2α=0.05) to detect a relative risk of ≤0.65, assuming the control group cumulative incidence of change in glycaemic category will be at least 20% (median follow-up 24 months), and allowing for 20% drop out from trial (data) follow up. A key secondary outcome is body weight; inclusion of 1414 women will provide 90% power to detect a difference of 1.80kg (assuming mean body weight of 64.2kg [sd 10.4] ) in the control group. Data management will be the responsibility of The George Institute for Global Health. An electronic Case Record Form and an appropriate electronic data management system will be utilised to capture and store study data. Around 25% of the 25 million pregnancies among Indian women each year are associated with gestational diabetes mellitus (GDM), and this proportion appears to be rapidly increasing over time [1] [2] [3] [4] [5] . In one report, somewhat lower prevalence rates for GDM for Sri Lanka (13%) and Bangladesh (10%) have been described [5] . Other data indicate higher GDM prevalence in Sri Lanka [6] , and while relevant data are limited in Bangladesh, population trends of type 2 diabetes mellitus (T2DM) in urban communities are very similar to those in India [7] . Prior GDM is an established risk factor for the future development of T2DM, with a large systematic review showing an estimated 7-fold greater risk in women with GDM compared to those with normoglycaemic pregnancies [8] . In the US Diabetes Prevention Program (DPP), women with prior GDM had a substantially higher incidence of T2DM compared with other pre-diabetic parous women (15.2 vs. 8.9 per 100 person-years) [9] . Indian data suggest that 35-40% of women with GDM will develop T2DM within 5 years of delivery [3] , more than double the rate observed in populations of largely white ethnicity [8] . Recent data have been obtained through a pilot study, PregDiabCare, in 2 urban Indian hospitals, funded by the International Diabetes Federation Bridges program [10] . Phase 1 of this pilot study aimed to provide contemporary data on the incidence of dysglycaemia after delivery in women with GDM. Among 366 women with prior GDM screened at a mean of 20 months post-delivery, 40% had impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and 32% had T2DMall new diagnoses. Only 28% had normal glucose tolerance (NGT). A proportion of those with T2DM may have had this condition pre-pregnancy but undiagnosed, however this is likely to be a very small fraction given the estimated prevalence of T2DM in the age-matched general population of <5% [11] . Previous randomised controlled trials (RCT) have demonstrated that lifestyle modification programs directed at individuals with pre-diabetes can prevent or delay the onset of T2DM [12] [13] [14] [15] [16] [17] . The DPP lifestyle intervention, conducted in a multi-ethnic US population was highly effective, with a number needed to treat of only 7 over 3 years [13] . In South Asia, the Indian Diabetes Prevention Programme (IDDP) [15] showed that in a mostly male, middle-aged Indian population with persistent IGT, a low intensity lifestyle modification was associated with a one-third reduction in T2DM incidence, over a median follow-up of 30 months. The 3-year cumulative incidence of T2DM in the control group of this study was 55%, so while the relative effects of the intervention in IDDP were smaller than those observed in DPP, the absolute reduction in development of T2DM was greater by virtue of the high baseline risk [13, 15] . To date, there are no completed adequately-powered trials of lifestyle interventions for T2DM prevention in women with prior GDM. In the cohort of 351 women with prior GDM included in DPP, the lifestyle intervention appeared to be more effective in preventing T2DM in comparison to parous pre-diabetic women without a history of GDM (50% vs 14% relative risk reduction) [9] . [9] . In populations outside of South Asia, data on the effectiveness of lifestyle interventions for diabetes prevention, specifically in women with prior GDM, are sparse. A recent cluster RCT involving 2320 women in the US [18] demonstrated that a DPP-derived, print/telephone-based lifestyle intervention was associated with modest reductions in postpartum weight retention [19] . Interim results of an individual RCT in China among 1180 women [20] are supportive of the effectiveness and feasibility of a lifestyle intervention program. In India, the Diabetes Community Lifestyle Improvement Program (D-CLIP) is currently evaluating a DPP-modified intervention in an RCT of approximately 600 men and women in India with dysglycaemia [21] . Less than 6% of D-CLIP participants have a history of GDM, and, to the best of our knowledge, there are no studies in South Asia among women with prior GDM, focused on T2DM prevention. In the absence of any proven lifestyle strategy for T2DM prevention among women with prior GDM in South Asian countries, we have drawn on four programs in developing the intervention proposed here. The first two are the DPP [13] and IDPP [15] studies (described above). The third is the intervention used in Phase 2 of PregDiabCare, which aimed to provide preliminary evidence about the feasibility and acceptability of a lifestyle program in Indian women with prior GDM [10] . The last is the Healthy Lifestyle Program for her (HeLP-her) [22] , a highly successful program focused on young women, tested in a variety of populations and settings, and now implemented by the government in Australia. A description of each of these programs, their evaluations, and key learnings relevant to the current study are described in Table 1 . A crucial component of any lifestyle intervention is its delivery by appropriately trained staff. While wealthier countries are able to utilise skilled and often highly qualified healthcare workers, such resources are severely limited in low-and middle-income countries. One strategy to address this is "task-shifting" -a situation where a task normally performed by a highly trained healthcare worker is transferred to one with a different or lower level of training, and/or without formal health education [23] . In low-and middle-income countries, task-shifting or task-sharing has been embraced as a strategy to address chronic shortfalls in numbers of highly trained health professionals for the management of infectious and maternal and childhood illness [24, 25] . Increasingly, there is interest in such strategies in the context of chronic non-communicable diseases. While the evidence base for effectiveness in this context is currently limited, a recent systematic review of task-shifting in low and middle-income countries for the prevention or control of chronic diseases found that robust initial and on-going training, and use of algorithms or protocols to support decision-making were key facilitators of success [26] . We will incorporate this evidence in developing a training package for non-physician healthcare workers to deliver the new lifestyle intervention. IDPP [15] PregDiabCare ( Healthy eating and physical activity education. Behaviour change: goal setting, relapse based on selfregulation theory. Self-management, nonprescriptive, simple eating and activity messages, small achievable changes to behaviour, based on self-determination theory. Self-management, nonprescriptive, simple eating and activity messages, small achievable changes to behaviour based on selfdetermination theory. At 2 yrs small weight gain in intervention and larger weight gain in control. 2 kg reduction in body weight, 2cm reduction in waist circumference from baseline not statistically significant. Intervention group lost 200gms, controls gained 810g over 1 year. Difference of 1.13kg. Better glucose and lipid profiles with intervention. By 28 wk gestation weight gain significantly lower with intervention (0.9kg), P < 0.05. Postpartum weight retention was lower with intervention, P<0.05. Summary of proposed work -We will take the learnings from the programs outlined in Table 1 to develop a new lifestyle program that has a high probability of being feasible, acceptable, and costeffective in the South Asian context for women with prior GDM. We will optimise this intervention using an iterative, systems-based, and user-centred approach. The intervention will be delivered by auxiliary nurse midwives or their equivalent in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. We will then evaluate this in a randomised controlled trial to determine whether it will reduce the incidence of T2DM and dysglycaemia, in a manner that is affordable, acceptable, and scalable. This project focuses on generating new knowledge on implementation of a preventive strategy embedded within existing health systems, using mixed-methods evaluation to inform cost-effectiveness, acceptability, and scalability. It represents a case study of "Integrated Innovation TM " [28] incorporating a science component (a program based on behaviour change theory that supports a multi-level approach to prevention by combining individually targeted strategies with social support), a social component (an innovative workforce strategy), and a sustainability component (a systems perspective for integration with existing health system infrastructure). To determine whether a resource-and culturally-appropriate lifestyle intervention program in South Asian countries, provided to women with gestational diabetes, after childbirth, will reduce the incidence of worsening of glycaemic status, in a manner that is affordable, acceptable, and scalable. An open-label parallel group pragmatic individual randomised controlled trial with blinded primary endpoint adjudication will be performed. The randomised controlled trial will be preceded by an intervention development and optimisation phase. The study will be conducted in approximately 24 hospitals and their catchment communities in 3 countries (Bangladesh, India, and Sri Lanka). This is an individual RCT in 1414 women from 24 hospitals in India (~700 participants from 12 hospitals), Bangladesh (~350 participants from 6 hospitals) and Sri Lanka (~350 participants from 6 hospitals). Design: A pragmatic prospective randomised open-label blinded outcome evaluation (PROBE) controlled trial, with mixed methods evaluation, will be conducted ( Figure 1 ). Central computer-based randomisation will be stratified by hospital, and use of insulin during index pregnancy. At each participating hospital, women with GDM will be identified at 24-34 weeks of gestation through the performance of a standard oral glucose tolerance test (OGTT) using the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria. 29 If a patient has undergone assessment of glycaemic status prior to 24 weeks' gestation, an OGTT must be performed to confirm the diagnosis between 24 and 34 weeks' gestation, unless she is treated with an oral hypoglycaemic drug and/or insulin before 24 weeks, and satisfies the IADPSG criteria for diagnosis of GDM. If only FPG was done at 24-34 weeks, then she will be categorized as GDM/overt diabetes/ normal on the basis of FPG value alone (see Figure 2 ). These individuals will receive standard GDM care, but will also be exposed to an additional brief standardised educational program to improve knowledge of nutrition and physical activity both during and after pregnancy. The study will also be discussed, as establishing rapport with the participants at this stage will be important to maximise participation in post-pregnancy screening. Further contact will be made with potential participants on at least one occasion after hospital discharge, and prior to 3 months post-childbirth, when women will be invited for an OGTT to determine trial eligibility. Those diagnosed with T2DM using ADA criteria at this time will be referred for appropriate care; all other women will be eligible for trial participation. The inclusion criterion, therefore, is the absence of T2DM (i.e. confirmation of NGT, IFG, or IGT) at 3 to 18 months post-partum OGTT. Consistent with design features of a pragmatic trial [29] , exclusion criteria will be limited to: □ Travel time to hospital more than 2 hours (unless individual circumstances will not impede hospital attendance for study visits) □ Lack of access to a mobile telephone □ Use of steroids during pregnancy other than for lung maturation of the baby □ Likelihood of moving residence in the next 3 years All reasons for exclusion or consent refusal will be carefully recorded. Provisionally, the intervention will include up to 4 face-to-face group sessions combined with remote on-going support, and an intensification offering when needed ( Table 2 ). However, depending on outcomes during the optimisation phase, the balance of face-to-face and remote contact might vary substantially overall, and between countries. Face-to-face sessions will be delivered by a trained facilitator using the existing HeLP-her training program optimised for each country. Eligible and consenting women will attend a local hospital in groups of not more than 10 women, and have baseline measures assessed prior to the commencement of the program. During session 1, they will receive a program-specific user manual, and over the following weeks, work through the behavioural skills sessions with a health worker trained in the delivery of the program. The participant manuals developed for the PregDiabCare pilot will undergo minor adaptation for use in each country. Following the face-to-face visits, participants will receive reminders, motivational messages, and small actionable behaviours delivered using mobile text messages and/or voice messages, which we will adapt from the WHO BE HE@LTHY BE MOBILE manual on implementing m Diabetes [30] . . At week 26 from the commencement of the intervention, participants will undergo a review of progress. Program intensification will be offered to women who gain weight by the 6 month time point: those who gain >2% of baseline weight (which accounts for transient weight fluctuations) will receive two intensification sessions of individualised coaching, and monthly phone coaching for the remaining 6 months, delivered by the trained facilitators. All phases of the program focus on self-management through small, feasible, and sustainable changes, by building knowledge and skills across 3 themes (1) simple healthy eating, and moderate physical activity messages; 2) behavioural skills, such as problem-solving, goal-setting, and self-monitoring; and 3) enhancing internal motivation, self-efficacy, and self-management. Simple messages regarding eating and physical activity give women an achievable context in which to begin to formulate their own health priorities. The program is deliberately not prescriptive, and has a focus on sustainable behaviours and local context. It is estimated, based on the previous HeLP-her trials, that ~ 30% of participants may require more intensive support, as planned in the intensification sessions. Week 52 End of intervention evaluation Individual visit Participants provide feedback on different elements of the intervention *From March 25, 2020, due to lockdown measures relating to the Covid-19 emergency, all intervention sessions will be held remotely (telephone or video), either individually or in groups. As weight change cannot be assessed during lockdown conditions, all participants who complete Session 4 will be offered intensification. This intervention is an innovative adaptation of existing programs to young women postchildbirth, in resource-poor settings, who are at high risk of T2DM. Implementation strategies which maximise accessibility, engagement, uptake, and retention have been incorporated. Although the behavioural content is similar across all programs that have informed its development, the intervention is unique in how women are engaged and retained, and how the intervention is packaged to ensure less burden on participants, ease of delivery by minimallytrained healthcare workers, and low cost. To maximise accessibility and uptake, while minimising attrition and cost, face-to-face meetings are kept to a minimum, offering an intensity step-up only for those who need it. In addition, a range of technologies is employed to deliver follow-up support and information to participants. Program facilitators who have completed programspecific training will deliver the intervention. Facilitators will be selected from auxiliary nurse midwives (or equivalent) and will undergo two days of training. Facilitators need excellent interpersonal skills, sound knowledge of evidence-based practice, an understanding of health, health behaviour, nutrition, and physical activity, and knowledge and experience in communicating with a variety of participants. Program-specific training includes both theory and practical components, and motivational interviewing techniques. Following the initial training, facilitators will attend monthly meetings for ongoing support and opportunities to discuss barriers and develop strategies to optimise the delivery of the program. Facilitators will be provided with implementation protocols, data-collection templates, and delivery and implementation resources such as scripts, food models, and photographs, and a selection of strategies to use to assist behaviour change. Prior to finalising the intervention, it will be optimised in a substantive formative phase as detailed in annexure 1. In each participating country, focus group discussions involving women with prior GDM will test the preliminary intervention design. In each participating country, a barriers analysis will be conducted to understand local contextual factors. This will be guided by Normalisation Process Theory [31] and Michie's behaviour change theories [29] to understand the capabilities, opportunities, and motivation of hospital administrators, existing auxiliary nurse midwives (or equivalent), and patients in relation to the intervention. In addition to desktop document analysis, process mapping work, semi-structured interviews, and focus group discussions with key stakeholders will be conducted. This will allow optimisation of the intervention for local delivery. This will also inform finalisation of the training program and material for the healthcare workers who will deliver the intervention (henceforth described as "facilitators"). All participants in the formative phase will be given information about the study and consent will be obtained (annexure 4). Control group participants will be referred to their usual doctor for ongoing management, with no attempt made to influence this. Any abnormal OGTT results during follow up will be provided to the patient and their doctor. This is entirely consistent with current usual care. Proportion of women with a change of glycaemic category, at or prior to final visit: Normal glucose tolerance (NGT) to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or T2DM; IFG or IGT to T2DM This will be diagnosed using ADA criteria as given below: Normal glucose tolerance (<100 mg/dL fasting and <140 mg/dL post-glucose load) Impaired glucose tolerance (<100 mg/dL fasting and 140-199 mg/dL post-load) Impaired fasting glucose (100-125 mg/dL fasting and <140mg/dL post-load) Type 2 diabetes (≥126 mg/dL fasting or ≥200 mg/dL post-load) If regional standards evolve to the diagnostic use of HbA1c with appropriate standardisation, we may migrate to this methodology depending on the timing and uptake of such changes. Fasting blood glucose Body weight Waist circumference Systolic blood pressure Physical activity level Diet The inclusion of 1414 women with GDM from 24 hospitals (~60/hospital) will provide 90% power (2α=0.05) to detect a relative risk of ≤0.65, assuming that the control group cumulative incidence for change in glycaemic category will be 20%, and allowing for 20% drop out (from follow-up, not intervention). Assuming that no more than 5% of individuals with T2DM had pre-existing undiagnosed pre-gestational T2DM, the PregDiabCare study results indicate an incidence of post-gestational T2DM of 27% at 20 months. Thus, with a median follow-up of 24 months, an assumed incidence of change in glycaemic category of 20% is conservative for the primary outcome and reasonable for the key secondary outcomes of T2DM. Analysis will be based on the principle of intention-to-treat. The effectiveness of the study intervention on the primary outcomes will be determined using Cox models for survival data, with censoring of participants who develop a subsequent pregnancy during follow-up. Given that the occurrence of primary outcomes can only be registered to the date of ascertainment during study visits, the use of other methods (e.g. Poisson regression) for the primary analysis will be explored during the blind review and will be finalised in the Statistical Analysis Plan prior to database lock and unblinding. Analyses of secondary outcomes will be conducted using standard statistical procedures applicable to dichotomous, categorical or continuous data as appropriate. A detailed process and outcome evaluation will be conducted to inform the successful implementation and scale-up of the intervention. It will also aim to inform for whom effectiveness was greatest and under what conditions or circumstances. A detailed awareness of local contextual factors will be critical in the process evaluation. It will be informed by Normalisation Process Theory [31] assessing how well the new service fits within the processes of current service provision in the hospitals, and by Michie's behaviour change theories [29] to understand capabilities, opportunities and motivations of various actors and how they interact. The RE-AIM framework [32] will be adopted to inform translation of research findings to practice by considering both the individual and population impact of the intervention and sustainability of behaviour changes over time. Individual, contextual, ecological and system level outcomes will be assessed using qualitative methods. A maximum variation sampling technique will be employed to ensure that diverse opinions are gained from patients, healthcare workers (auxiliary nurse midwives or equivalent), hospital administrators, and representatives of relevant government agencies, with broad representation across the 3 countries. A number of process and outcome variables will be explored, including program delivery, fidelity, acceptability, cost, efficacy, and sustainability, that might influence scale up. Key issues to explore include (1) how healthcare workers deliver the intervention; (2) what effects it has on organisational practices and personnel, and vice versa; and (3) what are patients' experiences with the study, the factors that influence their motivation to take up and continue with recommended lifestyle changes, the strategies they use to do so, and the role of their family and peers. Data will be collected at the end of the intervention period through the use of semi-structured, in-depth interviews, and focus group discussions. All participants for the process evaluation will be given information about the study, and their consent obtained. A separate ethics approval/amendment will be sought before conducting process evaluation. Data will be analysed contemporaneously until thematic saturation is achieved. A multidisciplinary research team will guide the analysis process. See annexure 10.5 for the detailed protocol of the process evaluation, including the interview and discussion schedules, and participant information sheets and consent forms. The economic evaluation will comprise a trial-based component and a modelled evaluation of long-term costs and outcomes. Intervention costs will be based on salaries and training. A within-trial comparison of health care costs (e.g. blood tests, hospital and clinic visits, and medications) will enable estimation of potential cost-offsets associated with the intervention. As we do not expect an effect of the intervention on survival, the (within-trial-based) incremental cost effectiveness ratio will be determined by average differences in utility observed between treatment arms in the trial. To capture costs and outcomes beyond the trial, a decision-analytic model will be developed to enable long-term morbidity, quality of life and survival to be simulated. The model will specify a number of health states (such as myocardial infarction, stroke, renal failure, type 2 diabetes with and without micro and macro-vascular complications, death and no disease) between which individuals cycle each year over a lifetime. It will draw on the literature and available databases to determine the transition probabilities between health states and the cost and quality of life associated with each. All patients will simulate progression across states until death. Incremental cost per Quality Adjusted Life Year (QALY) gained will be determined by then folding back the model to determine the average costs and outcomes, discounted at appropriate rate, accrued in both treatment arms. Sensitivity analysis will be conducted to determine the robustness of base case estimates to assumptions used in the economic evaluation. Randomisation will be conducted through a central, computer-based randomisation service, and will be stratified by country, centre, and use of insulin during pregnancy. By necessity, neither site investigators nor participants will be blinded to allocation (intervention vs. usual care). However, all central study staff, statisticians, and outcome adjudicators will remain blinded until final database lock. Follow-up data collection will operate on the principle of collecting the minimum information required to evaluate the major quantitative study outcomes. Data will be collected at randomisation and 6 monthly intervals thereafter, involving a case record form, with OGTT and HbA1c tests, alternately conducted at the follow-up 6-month visits, and both tests at the End of Study visit. Data will be captured electronically and data management will adhere to ICH-GCP guidelines, utilising Standard Operating Procedures established at participating institutes. Monitoring will be used to ensure quality and completeness of data, with an emphasis on central statistical monitoring to minimise costs. There will be 100% source data verification (against original laboratory reports) for all results from oral glucose tolerance tests, and of all HbA1c values. Data management will be the responsibility of The George Institute for Global Health. An electronic Case Record Form and an appropriate electronic data management system will be utilised to capture and store study data. Data management will be responsible for generating automatic data queries and tracking their resolution, as well as generating study management reports. Only authorised users with appropriate permissions will have access to the database. As the primary outcome is entirely dependent on changes in absolute values from oral glucose tolerance tests (and does not involve any other non-laboratory criteria), independent outcome adjudication will not be required. To ensure the accuracy of relevant data, 100% source data verification against laboratory reports will be undertaken by appropriately qualified central study staff who are blinded to intervention allocation. All serious adverse events must be reported during follow-up (from registration to 30 days after the final visit). A Serious Adverse Event (SAE) is any adverse event (any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study, regardless of causal relationship) that meets one or more of the following criteria: results in death; or is life threatening (see below); or requires hospitalization or prolongation of an existing hospitalization (see below); or results in a persistent or significant disability or incapacity (see below); or results in a congenital anomaly or birth defect Additionally, an important medical event that may not result in death, be life threatening, or require hospitalization may be considered an SAE when, based on appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above. Examples of such events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasia or convulsions that do not require hospitalization, or development of drug dependency or drug abuse. An adverse event is considered life threatening when this places the subject at immediate risk of death from the event as it occurred. A life-threatening event does not include an event that might have caused death had it occurred in a more severe form but that did not create an immediate risk of death as it actually occurred. For example, drug-induced hepatitis that resolved without evidence of hepatic failure would not be considered life threatening, even though drug-induced hepatitis of a more severe nature can be fatal. A hospitalization planned before the start of the study for a preexisting condition that has not worsened does not constitute an SAE (e.g. elective hospitalization for a cholecystectomy due to a preexisting condition of biliary colic that has not worsened during the study). Disability is defined as a substantial disruption in a person's ability to conduct normal activities of daily living. If there is any doubt whether an event constitutes an SAE, this event should be reported as an SAE. Any SAE should be reported within 24 hours of the investigator's or study coordinator's becoming aware of this. Reporting of SAEs to Ethics Committees will comply with local requirements. The Project Manager will devise a study monitoring plan which will be implemented by experienced monitors from each of the regional coordinating centres. Monitoring will take place to ensure compliance with the protocol GCP Principles and any local requirements. From March 25, 2020, due to lockdown measures relating to the Covid-19 emergency, the monitoring plan has been adjusted to a remote format. This study will be designed, conducted, analysed and reported in accordance with ICH-GCP Principles and all local requirements in each participating country. Ethics approval will be obtained from a number of ethics committees, including the University of Sydney Human Research Ethics Committee. In India, approvals from the Health Ministry Screening Committee and the All India Institute of Medical Sciences (Central Coordinating Centre) have been obtained. Further ethics committee approvals will be obtained from each hospital participating in India. In Sri Lanka, approval will be obtained from the Ethics Review Committee, Faculty of Medicine, University of Kelaniya, which is accredited by the Ministry of Health. In Bangladesh, ethics committee approval from icddr,b will be sufficient to allow involvement of all hospitals. The trial will be registered with the Clinical Trials Registry of India and the Sri Lanka Clinical Trials Registry before initiating the study. Participants willing to take part in the study will be consented by trial centres as per the ethical requirements. A two-stage consent process will be utilised; with written informed consent being obtained both at initial engagement during pregnancy, as well as prior to randomisation. Participants will be given adequate explanation about the study and will be given ample time to consider their trial participation. They will be given the opportunity to ask questions about the trial and what their participation involves, and will receive clarification from the investigator and other study staff. Prior to a subject's participation in the trial, a written informed consent form (using appropriately translated versions where appropriate) should be signed and personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion. If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion and must attest the written informed consent form. A copy of the signed written informed consent form will be given to the trial participant. All documents and data relating to this study are strictly confidential. Documents given to the investigators and trial centres by the Coordinating Centres should not be disclosed to other parties without the written approval of the sponsors. The investigator and his or her team should maintain confidentiality of the identity of all study participants and assure security and confidentiality of study data and documents. The Steering Committee will be the decision-making body for the trial. It will provide scientific direction to the study; approve t h e protocol and subsequent amendments; monitor study progress; and plan dissemination. The Steering Committee will meet through teleconference or other modes of communication at regular intervals to discuss study progress. In the event of a study related injury or death to a clinical trial participant, the sponsor(s) hold insurance policies to cover medical expenses and/or pay compensation in compliance with local ethical requirements. All essential trial documents will be archived and retained at the trial centre and/or coordinating centres for at least 15 years after the completion of the study. At the end of such period, the investigator shall notify, in writing, the project management team of its intent to destroy all study material. The steering committee will have full ownership of the study data, its storage, and dissemination. All publications will be reviewed and approved by the steering committee which will be named on all reports. The research teams, collaborating investigators and their respective centres will be named, and trial participants acknowledged in the final report and in publications arising from the trial. The aim of the LIVING study is to determine whether a resource and culturally appropriate lifestyle intervention program in South Asian countries (Bangladesh, India, Sri Lanka), provided to women with Gestational Diabetes Mellitus (GDM) after childbirth, will reduce the incidence of type 2 diabetes (T2DM) and dysglycaemia, in a manner that is affordable, acceptable and scalable. The intervention will be delivered by auxiliary nurse midwives or other relevant non-physician healthcare worker in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. We will then evaluate this in a Randomised Controlled Trial to determine whether it will reduce the incidence of T2DM and dysglycaemia, in a manner that is affordable, acceptable and scalable. Prior to the finalisation of the intervention, a qualitative formative process will be implemented to understand relevant local contextual factors (barriers and facilitators), behaviour of actors (capabilities, opportunities, motivations) and the health systems processes (actual and potential) for management of GDM and post-pregnancy care in the three countries. This will be guided by Normalisation Process Theory [1] and Michie's behaviour change theories [2] to understand the capabilities, opportunities and motivation of hospital administrators, existing nurse auxiliaries (or equivalent) and patients in relation to the intervention. In addition to desktop document analysis, process mapping work and semi-structured interviews, focus group discussions with key stakeholders will be conducted. This will allow optimisation of intervention for local delivery. This will also inform finalisation of the training program and material for the healthcare workers who will deliver the intervention (henceforth described as "facilitators").We will then optimise this intervention using an iterative, systems-based and user-centred approach. The formative stage research will be conducted in a total of 7 sites (4 in India, 2 in Bangladesh and 1 in Sri Lanka). The formative phase has 2 objectives: To explore how health systems diagnose and manage gestational diabetes, content of the intervention and the best method to deliver the intervention using the existing health systems infrastructure and workforce. To refine the content and process of intervention delivery Focus group discussion (FGD) 7 FGDs (one per hospital) with 6-8 women in each group. The focus groups will be comprised of post-partum women within 24 months of delivery who were previously diagnosed with GDM. A purposive sample of hospitals will be selected from study sites that have agreed to take part in the LIVING trial. One centre will be chosen in Sri Lanka, as this is considered sufficient to capture the likely diversity within the dominant health system. One public and one private hospital will be included from Bangladesh, North India and South India. Women with prior or current GDM will be purposively sampled from hospital records, with the objective of including some diversity related to sociodemographic background. These women will be contacted either by a phone call or during a visit to the hospital for routine care and written informed consent will be obtained from those who are willing to participate in the study. All interviews will be conducted by one or more trained social scientist(s). Written informed consent will include permission to record the FGD/interview and the participants will be informed about respondent confidentiality and data usage. The project team will brief the participants on the purpose of the study. The discussion topics will be simple and easy to understand. Prompts and probes will be used to encourage the group to expand and broaden their discussions. Each FGD/interview would be conducted by a team of two, a moderator and a note-taker, and would last for approximately 45-90 minutes. All the questions listed in FGD guide and Interview schedule will be flexible and open ended. All the interviews will take place at the health centre and interviews will be audio-recorded. The recorded interviews will be transcribed verbatim and translated to English (where necessary), and will be stored in Microsoft word format. Access to the data will only be given to the researchers involved in the qualitative study and will be solely used for the purpose of research. The audio recordings will be analysed using emergent codes to develop themes. The principles of thematic analysis for key issues, recurring issues and commonly emerging topics, to identify patterns will be used.Each of these items will be initially coded, and a coding scheme developed for compiling and grouping information from the various interviews. The study findings will be presented in an anonymous way with participants' quotes in order to corroborate the interpretation of analysis [3] . The steps of coding and charting will be done using NVIVO (QSR International, Melbourne, Victoria), a qualitative data analysis software. A multidisciplinary research team will guide the entire analysis process. FGDs and Interview data analyses will be utilised to inform the development of a culturally/contextually specific intervention for LIVING study. Objective 1 -To explore how health systems diagnose and manage gestational diabetes and the best method to deliver the intervention using the existing health system infrastructure and workforce. This will be addressed through in-depth interviews of relevant healthcare professionals (endocrinologists/obstetricians/hospital administrators/other care providers such as auxiliary nurse midwives or dieticians) and with post-partum women previously diagnosed with GDM in last 24months. Note: questions will vary according to type of healthcare professional. In your opinion, who would be the best health professional to deliver the intervention if it were to become usual practice? iii. In your opinion, what type of non-physician healthcare workers are available at the hospital who might have the ability to lead group sessions for women? Explore attitudes towards task-sharing. iv. According to you, do we need to provide incentives to participants attending the group sessions? If so, what type of incentives? b) What is your opinion on sustainability of the intervention, if the results of the study were to be positive? c) Logistics of the group sessions i. What do you think would be the ideal size of group for sessions? ii. What days / times of the week do you think would be most suitable to hold the session? iii. How easy will it be to find space for the sessions? iv. What are the ways to utilise the potential support from peers to encourage sustainable behaviour change? v. Do you think it would be feasible to create teams of 3-4 people within the group for internal monitoring of outcomes and enable teams to compare their performance against other teams? Generally, what type of food you have eaten after the child birth? d) Were you able to make decisions regarding your diet / food cooked at home after delivery? Are there any factors which have an impact on the mother's diet ( Probe: potential barriers and facilitators-family structure ,family support, resources available, customs and rituals) 4) Intervention a) Do you think women with GDM/postpartum in your hospital need some information to bring awareness in the patients' outlook towards GDM & its treatment? If yes, please elaborate. If no, give reasons. b) According to you what are the different ways which we can adopt to engage these women for our program? c) Please suggest the best way you feel this intervention can be delivered (probe: at the hospital/mode of delivery-phone call, SMS /frequency of contact) d) Do you have any suggestions on how to keep women engaged with us in year 2 and 3? e) What are the ways to utilise the potential support from peer/family members to encourage sustainable behaviour change? f) Who do you think will be the best person to deliver this intervention if this was to become a usual practice, why do you feel so (probe: doctor/nurse/counsellor/MSW) g) What are the major challenges you expect women to encounter while this intervention is being delivered? Can you suggest measures to overcome these? h) Do you feel this intervention should be a part of the usual care for GDM? i) How big should be a group? Why do you think this is an appropriate size? j) How much time should one group session last? k) Which days do you think are good for group sessions and what time do you think will be the best to conduct group sessions, why is it so? l) What should be an appropriate place to conduct these sessions? Why do you suggest this place? m) Do you have any more thoughts you would like to share with us? Do you have any questions for us? Any additional comments to be sought. Objective 2 -To refine the content and process of intervention delivery.This will be addressed through FGDs. Each focus group will include currently with or recently experienced (now postpartum) GDM. Each session is expected to last for 45-90 minutes. After providing a brief introduction to the study and intervention, collect the following information: a) Socio-demographic details -age, literacy status, economic status, residence (urban/rural), type of family (nuclear/extended), occupation, number of children, source of water, electrification, ownership of mobile phone, availability of cooking gas, availability of toilet facility at home and distance from the hospital. b) At your home who is in control of kitchen i.e. who makes the decisions related to dietary intake? Theme 1: Physical activity a) Explore perceptions of post-partum physical activity. b) Explore understanding of leisure time physical activity. c) Explore beliefs about adequate physical activity. d) Explore opportunities for exercise available and type of exercise available. e) Understand levels of exercise through household activities and perceptions of these being sufficient. c) Explore barriers to exercise (environmental or social barriers/lack of motivation/perceptions of post pregnancy weight gain). d) Explore potential facilitators of exercise. a) Explore perceptions about healthy diet (relationship to weight gain, content). b) Explore perceptions about post-partum diet (e.g. should be high in sugar and ghee). c) Explore barriers to dietary change (e.g. who makes choices about family diet?). d) Explore potential facilitators for dietary change. Theme 3: Patient journey once diagnosed with GDM a) Explore journey especially with respect to post-partum advice about future risks and how to manage these (including whether OGTT testing had been offered). b) Explore post-partum interactions with delivery hospital and opportunities for reengagement. c) Explore concerns regarding costs or inconvenience that may be associated with postpartum care focused on mother's future health. Theme 4: Postpartum screening a) Explore facilitators and barriers for returning for an OGTT in the post-partum period. After providing a brief introduction to the intervention: a) Explore reasons why women may or may not be interested in participating in the intervention. b) Explore potential facilitators of attendance (e.g. timing with well -baby or family planning services, providing child care). c) Explore preferences for size and timing of groups (day of week / time of day). d) Explore barriers/challenges to attend group sessions at prescribed intervals. e) Explore preferences for including family members / friends being involved in group sessions. f) Explore preference for type of health professional delivering group sessions. g) Explore preference for peer interactions. h) Preference of remote support strategies-phone call/SMS/smartphone apps and any facilitators or barriers to remote support (e.g. literacy, infrequent phone access). Asian women with gestational diabetes mellitus . This study will compare a low intensity post-delivery lifestyle program to usual care among women diagnosed with Gestational Diabetes Mellitus (GDM) during their recent pregnancy. Before you decide to participate, it is important for you to understand why the research is being conducted, and what it will involve. Please take the time to read the following information carefully and if you wish, please discuss it with your doctor, other healthcare provider, relatives and friends. Your participation is voluntary and you are entirely free to decide whether or not to take part in this study. If you choose to take part, you are free to withdraw at any time, without giving any reason. If you choose not to take part, your medical care or legal rights will not be affected, and you will continue to receive standard care given by your doctors and other healthcare providers. If there is anything that is not clear, or if you would like to have more information, please do not hesitate to ask the doctor or the study team. The trial doctor/research coordinator will discuss the study with you in detail. Once you understand the study and if you have no objections to your involvement, you will be asked to sign the consent form (last page of this document). By signing the consent form, you do not alter your legal rights, but you indicate that you understand the information and have no objection to participating in the study. You will be given a copy of this Participant Information Statement and Consent Form to keep for your records. What is this study about? Gestational diabetes mellitus is a form of diabetes consisting of high blood glucose (sugar) levels during pregnancy. It develops in 4% pregnancies worldwide and is associated with complications to both mother and baby. In South Asia, the GDM rate is much higher and appears to be increasing over time. High blood glucose levels usually disappear after pregnancy, but women with GDM and their children are at an increased risk of developing type 2 diabetes later in life. Type 2 diabetes is a lifelong condition often requiring long term medication use and associated with increased risks of heart disease, stroke, kidney disease, and eye disease. Studies from India suggest that 35-40% of women with GDM will develop type 2 diabetes within 5 years of delivery. There is evidence that lifestyle modification programs can be useful in delaying the development of type 2 diabetes among other groups of people at high risk of developing this condition. However, it is not known whether a lifestyle modification program developed for women in South Asia with previous GDM can be successful is preventing the development of type 2 diabetes. In this study, we will develop and test a new low intensity lifestyle program that has a high probability of being feasible, acceptable and affordable in the South Asian context for women with prior GDM. Who is running the study? In India, the study is being conducted by the All What will the study involve for me? There are two stages of involvement in this study. At this stage, women with GDM will be identified at 24-34 weeks pregnancy through the performance of a standard Oral Glucose Tolerance Test (OGTT). This test will be performed if this has not already been done as part of your routine care during pregnancy. If you are found to have GDM, you will receive appropriate care for this condition, but we will also provide education to improve your knowledge about diet and physical activity both during and after pregnancy. We will collect your contact details and preferred method of contact. Within the first 6 months after delivery, we may contact you one or more times to check your progress and to remind you to attend an appointment at 6 months post-delivery. When you attend this appointment, we will perform another OGTT. If this test shows that you have developed type 2 diabetes, we will refer you to a doctor for proper care; otherwise, we will invite you to participate in the second stage of the study which is aimed at testing a new lifestyle modification program. This will be discussed with you in more detail if you agree to participate in stage 2. When you visit the hospital for your routine care at 24-34 weeks of pregnancy, you will be offered an OGTT to determine if you have GDM. You may have already had this test done, and, if so, it will not be repeated. The OGTT requires you to fast overnight (no food from 10:00 pm until the time of the test the next morning). When you come to the hospital for your OGTT, you will have a blood test (two ml or half teaspoonful of blood will be obtained), be asked to drink a solution of glucose (sugar), and one and two hours later, you will have blood samples withdrawn (two ml or half teaspoonful of blood will be obtained at each time). If you are diagnosed with GDM during your antenatal visit, you will be briefed about the study. If you are interested in the study, you will need to indicate your voluntary willingness to participate by signing the Consent Form. Whether or not you agree to participate in the study, you will receive standard treatment for GDM, and we will also provide you with information to improve your knowledge about nutrition, physical activity and managing stress both during and after pregnancy. Details of the post pregnancy phase of the study will also be discussed with you. Your permission will be obtained to contact you after delivery, and preferred contact method and details will be collected at this point. The study doctor/research staff will then collect basic information about you. You will be invited to come back when your baby becomes 6 months old (Post-Delivery Visit). A blood test and another OGTT will be performed. At this stage if you are diagnosed with type 2 diabetes, you will be referred to a doctor for proper care. If not, you will be asked to participate in the post-pregnancy stage 2 of the study, which will test the lifestyle modification program. This will be explained to you in detail and you can make a decision then about whether or not you wish to participate in this stage of the study. How much of my time will the study take? Interviews conducted by the research team will take between 40 to 60 minutes. We appreciate your other commitments and will fit in with your schedule. Who can participate in this study? You can participate in this study if: You are aged 18 years or older, and are 24-34 weeks pregnant You will not be able to take part in the study if: you have already had a test that shows that you do not have GDM your residence is too far from hospital you or your family does not have a usable mobile phone Do I have to be in the study? Can I withdraw from the study once I have started? At this stage, the actual study (recruitment of participants) has not yet began. We will approach you for a second stage consent between 3-9 months after your delivery. However, being in this study is completely voluntary and you do not have to take part. Your decision whether to participate will not affect your current or future relationship with the researchers or any individuals or organizations related to this study. If you decide to take part in the study and then change your mind later, you are free to withdraw at any time by informing to the doctor or study facilitator at the hospital. If you decide to withdraw from the study, we will not collect any more information from you. Please let us know at the time when you withdraw what you would like us to do with the information we have collected about you up to that point. If you wish, your information will be removed from our study records and will not be included in the study results. What are the possible risks and benefits of participation in this study? There will be no costs associated for being in the study. This study will not involve the use of any drugs, medications or procedures. The risks of participating in this study include: Blood collection: There may be temporary bruising, discomfort, or local irritation of the skin where the blood sample is taken. Giving up your time to participate in the study: This might cause some inconvenience but we will try to fit the program in to your schedule (e.g., hospital visits). This study will provide you with some information about healthy lifestyle changes to control your blood glucose levels and the risks of developing type 2 diabetes. All blood test results will be provided to you, and you can show them to your usual doctor. If you take part in this study you need to agree to provide correct information to the best of your knowledge visit the trial centre for the post-delivery visit give blood samples as per the schedule advised by the study team While you are in this study you should not participate in any other research study. Inform the study team if you do not want to continue your participation in the study. If you suffer any injuries or complications as a direct result of being in the study, you should contact the study doctor who will assist you in arranging the appropriate medical treatment, as soon as possible. The sponsor(s) holds insurance policies to cover medical care and/or compensation in case of any such events. If you have any questions concerning the availability of medical care or if you think you have experienced a research-related illness, injury or emergency, contact Dr. ___________________________ Phone: _________________________________ (Site level doctor details will be inserted later) You will be informed in a timely manner if any new information becomes available that may be relevant to your willingness to continue participation in the study. Your participation in this study may be stopped if the study is terminated. The study doctor will make sure you receive appropriate ongoing care. You do not have to participate in this study to receive medical advice for any condition. All information collected about you will be kept strictly confidential. Your initials and date of birth will be used as identifiers in the study. Only study monitors, auditors, and the Ethics Committee will be granted direct access to your records for verification of study procedures and/or data, without violating your confidentiality, to the extent permitted by the applicable laws. By signing a written informed Consent Form, you authorise such access. Study findings may be published but you will not be individually identified in these publications. All records and data relating to the study will be destroyed in a secure manner, 15 years after the end of this study while protecting your confidentiality. The blood sample/s you provide during the study will not be stored for further use. Copies of the test reports will be given to you for your records. Your results will be kept confidential and will not be disclosed to any third party. At this stage of the study no treatment or intervention is involved. Your doctor will continue to provide you with appropriate care. You will not be paid for taking part in this study. However, you will be reimbursed for reasonable travel expenses for study visits to the hospital. Yes, you are welcome to tell other people about the study. When you have read this information, a member of the research team will be available to discuss it with you further and answer any questions you may have. You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by ticking the relevant box at the end of the consent form. Please also tick your preferred method of receiving information. The results of the blood tests will be provided to you as soon as they are available from the laboratory. Research involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. If you have any complaints regarding the research you may also contact the Patient Representative at your hospital/ the member secretary of the overseeing ethics committee, whose contact details are provided below. [relevant ethics committee from below] India -Details of site specific hospital HRECs will be added later. You are invited to take part in a research study called LIVING (Lifestyle InterVention IN Gestational diabetes). This study will compare a low intensity post-delivery lifestyle program to usual care among women diagnosed with Gestational Diabetes Mellitus (GDM) during their recent pregnancy. Before you decide to participate, it is important for you to understand why the research is being conducted, and what it will involve. Please take time to read the following information carefully, and if you wish, please discuss it with your doctor, other healthcare provider, relatives and friends. Your participation is voluntary and you are entirely free to decide whether or not to take part in this study. If you choose to take part, you are free to withdraw at any time, without giving any reason. If you choose not to take part, your medical care or legal rights will not be affected and you will continue to receive the usual care given by your doctors and other healthcare providers. If there is anything that is not clear, or if you would like to have more information, please do not hesitate to ask the doctor or the study team. The trial doctor/research coordinator will discuss the study with you in detail. Once you understand the study and if you have no objections to your involvement, you will be asked to sign the Consent Form (last two pages of this document). By signing the Consent Form you do not alter your legal rights, but you indicate that you understand the information and have no objection to participating in the study. You will be given a copy of this Participant Information Statement and Consent Form to keep for your records. (2) What is this study about? Gestational diabetes mellitus (GDM) is a form of diabetes consisting of high blood glucose (sugar) levels during pregnancy. It develops in 4% pregnancies worldwide and is associated with complications to both mother and baby. In South Asia, the GDM rate is much higher and appears to be increasing over time. High blood glucose levels usually disappears after pregnancy but women who have had GDM and their children are at an increased risk of developing type 2 diabetes later in life. Type 2 diabetes is a lifelong condition usually requiring long term medication use and associated with increased risks of heart disease, stroke, kidney disease and eye disease. Studies from India suggest that 35-40% of women who have had GDM will develop type 2 diabetes within 5 years of delivery. There is evidence that lifestyle modification programs can be useful in delaying the development of type 2 diabetes among other groups of people at high risk of developing this condition. However, it is not known whether a lifestyle modification program developed for women in South Asia with previous GDM can be successful is preventing the development of type 2 diabetes. In this study, we will develop and test a new low intensity lifestyle program that has a high probability of being feasible, acceptable and affordable in the South Asian context for women with prior GDM. You were diagnosed with gestational diabetes mellitus during your recent pregnancy. We will test your blood glucose at a post-delivery visit, 3 to 18 months after childbirth, and invite you to participate in the LIVING study if this test shows that you are not diabetic. The following will occur during study visits: An Oral Glucose Tolerance Test (OGTT), and HbA1c test will be performed. The OGTT requires you to fast overnight (no food from 10:00 pm until the time of the test the next morning). When you come to the hospital for your OGTT, you will have a blood test (two ml or half teaspoonful of blood will be obtained), be asked to drink a solution of glucose (sugar), and one and two hours later, you will have blood samples withdrawn (two ml or half teaspoonful of blood will be obtained at each time). At this stage if you are diagnosed with type 2 diabetes, you will be referred to a doctor for proper care. If not, you will be invited to participate in the LIVING study, which will test the lifestyle modification program. After you agree to participate in the study, you will be asked questions about your medical history, the medicines you are taking, and lifestyle factors, such as smoking, diet and exercise. You will have your heart rate, blood pressure, height, weight, and waist circumference measured. You will also be asked questions about any recent visits to, tests performed by, or treatments given by any healthcare provider. You will be randomly (like with a toss of a coin) allocated to either having your normal postpregnancy care (control arm), or in addition to your normal post-pregnancy care, take part in a lifestyle modification program (intervention arm) aimed at promoting physical activity, nutrition, and reduced stress levels. If you are allocated to the control arm, you will be seen at the hospital by the study team every 6 months for an average of 2 years (follow-up study visits), for blood tests and other assessments. If you are allocated to the intervention arm, you will be seen at the hospital by the study team every 6 months for an average of 2 years (study visits), for blood tests and other assessments. In addition, you will participate in a lifestyle modification program that includes 4 face-to-face group sessions, combined with ongoing support through a range of activities that may include text or voice messaging, and phone calls.. The group sessions may be videorecorded, audiorecorded, and/or observed remotely via video/telephone calls by the research team. Any videorecording will be focused on the facilitator only. At these visits, you will be asked about lifestyle factors, such as diet, exercise, and tobacco use. You will have your heart rate, blood pressure, weight, and waist circumference measured. You will be asked questions about any recent visits to, tests performed by, or treatments given by any healthcare provider. Any serious new health problems will also be recorded. At these visits, you will be asked about lifestyle factors such as diet, exercise, and tobacco use. You will have your heart rate, blood pressure, weight, and waist circumference measured. You will be asked questions about any recent visits to, tests performed by, or treatments given by any healthcare provider. Any serious new health problems will also be recorded. In addition blood tests will be performed, including an Oral Glucose Tolerance Test (OGTT). This test requires you to fast overnight (no food from 10:00 pm until the time of the test the next day). When you come to the hospital for your OGTT, you will have a blood test (two ml or half teaspoonful of blood will be obtained), be asked to drink a solution of glucose, and two hours later, you will have another blood tests (two ml or half teaspoonful of blood will be obtained again). At the end of the study, you may be invited to take part in an interview which aims to explore your views on the benefits, disadvantages, and acceptability of the lifestyle modification program. It can be a semi structured interview or a focus group discussion (FGD). The interview will be informal with several questions being asked. It will cover information about your life and your health experience and views about the program. The interview will last for approximately one hour and may occur at the same time as your end of study visit, or at a separate time after this, either at the hospital or at your home. During the interview if a question is asked that you do not want to answer, please just say so. The researcher will then move on to another question. The researcher will record the interview, and afterwards the tapes will be used to make a written record. The written record will only be identified by your initials and a study number. Anything you say will be completely confidential and cannot be traced back to you when the research results are published. We may also conduct focus group discussions where we will ask questions related to your experiences with the intervention. About 6-8 women will participate in each group discussion. All FGDs will be digitally recorded, professionally transcribed and your name and personal details will be removed for analysis purposes. The data will be analysed by a small team of experienced researchers and will be stored on a secure, password protected folder accessible only to the researchers. We seek permission to use quotes from your interview in our reports but none of this information will allow identification of an individual person. If you are included in process evaluation, a detailed participant information sheet will be given to you before obtaining a consent from you to participate in the study. The intervention (only for members of the intervention group) includes 4 face-to-face group sessions (one session per week) over the first 6 months. Approximately 2 hours of your time will be required for each face-to-face group session that includes the intervention, as well as relevant study procedures. Apart from this, you are also encouraged to follow a lifestyle modification program as part of your routine daily schedule as per your convenience. Follow-up visits for all participants, including blood tests and other investigations, which will take about 2 hours each visit, will be conducted every 6 months at the hospital. You can participate in this study if: You are aged 18 years or older, and diagnosed with GDM during the antenatal period. You will not be able to take part in the study if: you have already developed type 2 diabetes the travel time from your residence to the hospital is over 2 hours (unless individual circumstances will not impede hospital attendance for study visits) you or your family do not have a usable mobile phone (7) Do I have to be in the study? Can I withdraw from the study once I have started? Being in this study is completely voluntary and you do not have to take part. Your decision whether to participate will not affect your current or future relationship with the researchers or any individuals or organizations related to this study. If you decide to take part in the study and then change your mind later, you are free to withdraw at any time by informing the doctor or study facilitator at the hospital. If you decide not to take part in the study, and you wish to continue treatment, you will still receive the standard treatment available for your condition. It is important that you discuss the alternatives to participating in this study with your doctors. Data that can be withdrawn: If you decide to withdraw from the study, we will not collect any more information from you. Please let us know at the time when you withdraw what you would like us to do with the information we have collected about you up to that point. If you wish, your information collected during in-depth interviews will be removed from our study records and will not be included in the study results, up to the point that we have analysed and published results. Data that cannot be withdrawn: If you decide to withdraw from the study, we will not collect any more information from you. However, we wish to inform you that due to the nature of group discussions it will not be possible to delete the information from video or audio recordings. In this case, any information already collected will be kept in our records and may be included in the study results. There will be no costs associated for being in the study. This study will not involve use of any drugs, medications or procedures. The risks of participating in this study include: Blood collection: There may be temporary bruising, discomfort, or local irritation of the skin where the blood sample is taken. Giving up your time to participate in the study: This might cause some inconvenience but we will try to fit the program in to your schedule (e.g., hospital visits). Interview: At the end of the study, during the interview there is a risk that a topic could be raised that you may find upsetting. If you find this, please say so. The recording will be stopped immediately. The interview and recording will only start again if you agree and a different topic will be discussed. You might worry afterwards about something you said in the interview. There is no need for this as everything is treated in strict confidence. All the recordings and written records will be made anonymous. If you are still worried, you can contact the interviewer to discuss your concerns. Benefits This study will provide you with some information about healthy lifestyle changes to control your blood glucose levels and the risks of developing type 2 diabetes, independent of the arm to which you are randomised. All study test results will be provided to you, which you can show to your usual doctor. While it is hoped that this study improves medical knowledge and may improve treatment for women who have had GDM, it may not be of direct benefit to you beyond your usual treatment that you would receive from your doctor, and other healthcare providers. Information about the study may be useful in the future to a large number of people if the lifestyle modification program is shown to reduce the risks of developing abnormal blood glucose levels and / or type 2 diabetes, or otherwise. At the end of the study, you will have a chance to talk about your experiences, which you may find helpful. If you take part in this study you need to agree to provide correct information to the best of your knowledge, including information on blood glucose tests during your recent pregnancy visit the trial centre as per the study visits schedule advised by the study team discuss your current medications with the study team and any new medications prescribed by other doctors agree to give blood samples as per the schedule advised by the study team read the SMSs, or listen to the voice messages, sent by the study team. If you have lost your phone, inform the study team If you become pregnant again, inform the study team. tell the study team about any medical problems, doctor visits, hospital visits, or medical procedures that you have while you are in the study not participate in any other interventional research study while you are in this study inform the study team if you do not want to continue your participation in the study. If you suffer any injuries or complications as a direct result of being in study, you should contact the study doctor, who will assist you in arranging the appropriate medical treatment, as soon as possible. The sponsor(s) holds insurance policies to cover medical care and/or compensation in case of any such events. If you have any questions concerning the availability of medical care, or if you think you have experienced a research-related illness, injury or emergency, contact Dr. ___________________________ Phone: _________________________________ (Site level doctor details will be inserted later) You will be informed in a timely manner if any new information becomes available that may be relevant to your willingness to continue participation in the study. After you complete the study, your doctor will decide, in consultation with you, any treatment that is best for you. In addition, the study team will advise you to inform them and see the doctor promptly if any major health problems occur within 1 month of study completion. Your participation in this study may be stopped if the study is terminated. The study doctor will make sure you receive appropriate ongoing care. You do not have to participate in this study to receive medical advice for any condition. All information collected about you will be kept strictly confidential. Your initials and date of birth will be used as identifiers in the study. Only study monitors, auditors, and the Ethics Committee will be granted direct access to your records for verification of study procedures and/or data, without violating your confidentiality, to the extent permitted by the applicable laws. By signing a written Informed Consent Form, you authorise such access. Study findings may be published, but you will not be individually identified in these publications. All records and data relating to the study will be destroyed in a secure manner, 15 years after the end of this study, while protecting your confidentiality. The blood sample/s you provide during the study will not be stored for further use. Copies of the test reports will be given to you for your records. Your results will be kept confidential and will not be disclosed to any third party. (16) Will I be paid for taking part in this study? You will not be paid for taking part in this study. However, you will be reimbursed for reasonable travel expenses for study visits to the hospital. If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. You are invited to take part in the formative phase of a lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus (GDM). The main study aims to determine whether a resource-and culturally-appropriate lifestyle modification program in South Asian countries, provided after childbirth, to women with GDM, will reduce the occurrence of abnormal blood glucose levels and type 2 diabetes, in a manner that is affordable and acceptable. In this study, we will develop and evaluate a new low intensity lifestyle program that has a high probability of being feasible, acceptable and affordable in the South Asian context for women with prior GDM. This formative phase of the study will include gathering of information from the health care providers, hospital administrators and women with current or previous GDM. You have been invited to participate in this study as your hospital is taking part in the study. Interviews will be conducted by the research team and involve gathering information about the diagnosis, management and referral pathways for GDM that could support the LIVING intervention. Interviews will be conducted to explore the feasibility of the intervention program including factors that might influence uptake of the program as part of your routine care with patients. All interviews will be digitally recorded, professionally transcribed and your name and personal details will be removed for analysis purposes. You will be identified by a unique study identification number. The data will be analysed by a small team of experienced researchers and will be stored on a secure, password protected folder accessible only to the researchers. We seek permission to use quotes from your interview in our reports but none of this information will allow identification of an individual person. At the conclusion of the research, the information collected will be securely stored for 15 years minimum is accordance with ethics regulations. Interviews conducted by the research team will take between 45 to 90 minutes. We appreciate your work commitments and will fit this in with your schedule. Your hospital has agreed to participate in the LIVING study. We are now inviting you to participate in the formative phase of the study. You are free to discontinue your involvement with this study at any time by informing us. Your decision whether or not to participate will not affect your current or future relationship with the researchers or organizations related to this study. If you decide to withdraw from the study, we will not collect any more information from you. Please let us know at the time when you withdraw what you would like us to do with the information we have collected about you up to that point. If you wish, your information will be removed from our study records and will not be included in the study results, up to the point that we have analysed and published the results. Aside from giving up your time, we do not expect that there will be any risks or costs associated with taking part in this study. This study is not associated with any financial benefits to researchers and affiliated organizations. This research is intended to better our understanding of lifestyle intervention models in the prevention and delaying of type 2 diabetes for women diagnosed with gestational diabetes. From this process an appropriate standardized lifestyle intervention program will be developed eventually. We will be only collecting information from you by asking few questions and you will not be exposed to any drug, medication or procedure. If you suffer any injuries or complications as a direct result of being in the study, you should contact the study investigator as soon as possible, who will assist you in arranging the appropriate medical treatment. In such cases, to cover medical care and/or compensation in case of any such events the sponsor(s) holds insurance policies. If you have any questions concerning the availability of medical care or if you think you have experienced a research-related illness, injury or emergency, contact Dr. ___________________________ Phone: _________________________________ (Site level doctor details will be inserted later) We intend that this formative phase will assist in the development of the LIVING study intervention which aims to prevent developing type 2 diabetes in women with prior gestational diabetes. We cannot, however, guarantee that it will be of direct benefit to you. (11) What will happen to information about me that is collected during the study? By providing your consent, you are agreeing to us collecting personal information about you for the purposes of this research study. Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise. The information collected during the formative phase of the study will be treated as strictly confidential and not released to anyone outside the research team, except as required by law. The information provided to the researchers will not include any personal information and will be identified by a unique study number only. Study findings may be published but you will not be individually identified in these publications. Yes, you are welcome to tell other people about the study. When you have read this information, a member of the research team will be available to discuss it with you further and answer any questions you may have. (14) Will I be told the results of the study? You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by ticking the relevant box on the consent form. You will receive a summary of the research study results after the study is finished. Research involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of [to be replaced by relevant institution and protocol number]. As part of this process, we have agreed to carry out the study according to the Australian National Statement on Ethical Conduct in Human Research (2007) . If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. If you have any complaints regarding the research you may also contact the Patient Representative at your hospital/ the member secretary of the overseeing ethics committee, whose contact details are provided below. India -Details of site specific hospital HRECs will be added later. I understand that being in this study is completely voluntary, and I do not have to take part. My decision whether to participate will not affect my current or future relationship with the researchers at The George Institute and The University of Sydney I understand that I can withdraw from the study at any time. I understand that personal information about me that is collected over the course of this project will be stored securely and will only be used for purposes that I have agreed to. I understand that information about me will only be told to others with my permission, except as required by law. I understand that the results of this study may be published, and that publications will not contain my name or any identifiable information about me. I agree to take part in an interview for the study. You are invited to take part in the formative phase of a lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus. Gestational diabetes mellitus (GDM) is a form of diabetes consisting of high blood glucose (sugar) levels during pregnancy. It develops in 4% pregnancies worldwide and is associated with complications to both mother and baby. In South Asia, the GDM rate is much higher and appears to be increasing over time. High blood glucose levels usually disappear after pregnancy but women with GDM and their children are at an increased risk of developing type 2 diabetes later in life. Type 2 diabetes is a lifelong condition often requiring long term medication use and associated with increased risks of heart disease, stroke, kidney disease and eye disease. Studies from India suggest that 35-40% of women with GDM will develop type 2 diabetes within 5 years of delivery. There is evidence that lifestyle modification programs can be useful in delaying the development of type 2 diabetes among other groups of people at high risk of developing this condition. However, it is not known whether a lifestyle modification program developed for women in South Asia with previous GDM can be successful in preventing the development of type 2 diabetes. This study aims to determine whether a resource-and culturally-appropriate lifestyle modification program in South Asian countries, provided to women with GDM after delivery, will reduce the occurrence of abnormal blood glucose levels and type 2 diabetes, in a manner that is affordable and acceptable. In this study, we will develop and test a new low intensity lifestyle program that is aimed to be acceptable and affordable in the South Asian context for women with prior GDM. The formative phase of this study will include in-depth interviews with women who either have or were diagnosed with GDM in order to refine the intervention. You have been invited to participate in this study as you were diagnosed with GDM during your current or previous pregnancy. This Information Statement tells you about the research study. Knowing what is involved will help you decide if you want to take part in the research. Please take the time to read this information carefully. Please ask questions about anything that is not clear, or you want to know more about. By giving your consent to take part in this study you are telling us that you: Understand what you have read. Agree to take part in the research study as outlined below. Agree to the use of your personal information as described. You will be given a copy of this Information Statement to keep. In India, the study is being conducted by the All India Institute of Medical Sciences, New Delhi and The George Institute for Global Health, Hyderabad. In Bangladesh, the study is being conducted by International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka and in Sri Lanka by the University of Kelaniya, Sri Lanka. The study is funded by the Indian Council of Medical Research and the National Health and Medical Research Council of Australia and as a part of The Global Alliance for Chronic Diseases scheme. The study is being carried out by following researchers: Interviews will be conducted by the research team and involve gathering information about the diagnosis, management and referral pathways for GDM that could support the LIVING intervention. Interviews will be conducted to explore the feasibility of the intervention program including factors that might influence uptake of the program as part of routine care provided in the hospitals. All interviews will be digitally recorded, professionally transcribed and your name and personal details will be removed for analysis purposes. You will be identified by a unique study identification number. The data will be analysed by a small team of experienced researchers and will be stored on a secure, password protected folder accessible only to the researchers. We seek permission to use quotes from your interview in our reports but none of this information will allow identification of an individual person. At the conclusion of the research, the information collected will be securely stored for 15 years minimum is accordance with ethics regulations. The interviews conducted by the research team will take around 45-90 minutes. We appreciate your other commitments and will fit with your schedule. You can participate in this study if you have been diagnosed to have GDM in your current or previous pregnancy. Participating in this evaluation is completely voluntary and you do not have to take part. You are free to discontinue your involvement with this study at any time by informing us. Your decision whether or not to participate will not affect your current or future relationship with the researchers or organizations related to this study. If you decide to withdraw from the study, we will not collect any more information from you. Please let us know at the time when you withdraw what you would like us to do with the information we have collected about you up to that point. If you wish, your information will be removed from our study records and will not be included in the study results, up to the point that we have analysed and published the results. There would be no costs associated for being in the study. Aside from giving up your time, we do not expect that there will be any risks or costs associated with taking part in the interviews. If you take part in this evaluation, you will not be paid to participate. This research is intended to better our understanding of ways to prevent or delay type 2 diabetes among the women diagnosed with gestational diabetes. The formative research is not associated with any financial benefits to the researchers or affiliated organisations. If you suffer any injuries or complications as a direct result of being in study, you should contact the study doctor as soon as possible, who will assist you in arranging the appropriate medical treatment. In such cases, to cover medical care and/or compensation in case of any such events the sponsor(s) holds insurance policies. If you have any questions concerning the availability of medical care or if you think you have experienced a research-related illness, injury or emergency, contact Dr. ___________________________ Phone: _________________________________ (Site level doctor details will be inserted later) You will not be paid for taking part in this study and there are no other financial benefits (direct or indirect). However, you will be reimbursed for reasonable travel expenses for attending the interviews. By providing your consent, you are agreeing to us collecting personal information about you for the purposes of this research study. Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise. The information collected during the formative phase of the study will be treated as strictly confidential and not released to anyone outside the research team, except as required by law. The information provided to the researchers will not include any personal information and will be identified by a unique study number only. Study findings may be published but you will not be individually identified in these publications. Yes, you are welcome to tell other people about the study. When you have read this information, a member of the research team will be available to discuss it with you further and answer any questions you may have. You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by ticking the relevant box on the consent form. If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. Telephone: +61 2 8627 8176 Email: ro.humanethics@sydney.edu.au Fax: +61 2 8627 8177 (Facsimile) If you have any complaints regarding the research you may also contact the Patient Representative at your hospital/ the member secretary of the overseeing ethics committee, whose contact details are provided below. India -Details of site specific hospital HRECs will be added later. I understand that I can withdraw from the study at any time. I understand that personal information about me that is collected over the course of this project will be stored securely and will only be used for purposes that I have agreed to. I understand that information about me will only be told to others with my permission, except as required by law. I understand that the results of this study may be published, and that publications will not contain my name or any identifiable information about me. You are invited to take part in the formative phase of a lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus. Gestational diabetes mellitus (GDM) is a form of diabetes consisting of high blood glucose (sugar) levels during pregnancy. It develops in 4% pregnancies worldwide and is associated with complications to both mother and baby. In South Asia, the GDM rate is much higher and appears to be increasing over time. High blood glucose levels usually disappear after pregnancy but women with GDM and their children are at an increased risk of developing type 2 diabetes later in life. Type 2 diabetes is a lifelong condition often requiring long term medication use and associated with increased risks of heart disease, stroke, kidney disease and eye disease. Studies from India suggest that 35-40% of women with GDM will develop type 2 diabetes within 5 years of delivery. There is evidence that lifestyle modification programs can be useful in delaying the development of type 2 diabetes among other groups of people at high risk of developing this condition. However, it is not known whether a lifestyle modification program developed for women in South Asia with previous GDM can be successful in preventing the development of type 2 diabetes. This study aims to determine whether a resource-and culturally-appropriate lifestyle modification program in South Asian countries, provided to women with GDM after delivery, will reduce the occurrence of abnormal blood glucose levels and type 2 diabetes, in a manner that is affordable and acceptable. In this study, we will develop and test a new low intensity lifestyle program that is aimed to be acceptable and affordable in the South Asian context for women with prior GDM. The formative phase of this study will include group discussion with women who either have or were diagnosed with GDM in order to refine the intervention. You have been invited to participate in this study as you were diagnosed with GDM during your current or previous pregnancy. This Information Statement tells you about the research study. Knowing what is involved will help you decide if you want to take part in the research. Please take the time to read this information carefully. Please ask questions about anything that is not clear, or you want to know more about. By giving your consent to take part in this study you are telling us that you: Understand what you have read. Agree to take part in the research study as outlined below. Agree to the use of your personal information as described. You will be given a copy of this Information Statement to keep. In India, the study is being conducted by the All India Institute of Medical Sciences, New Delhi and The George Institute for Global Health, Hyderabad. In Bangladesh, the study is being Group discussions with selected participants will be conducted to understand the usefulness and acceptability of the intervention program. If you agree to participate, we will invite you for a group discussion where we will ask questions related to the diagnosis and treatment of gestational diabetes, discuss your experience in accessing services, and seek your opinion about the lifestyle intervention planned for this study. About 6-8 women will participate in each group discussion. All interviews will be digitally recorded, professionally transcribed and your name and personal details will be removed for analysis purposes. You will be identified by a unique study identification number. The data will be analysed by a small team of experienced researchers and will be stored on a secure, password protected folder accessible only to the researchers. We seek permission to use quotes from your interview in our reports but none of this information will allow identification of an individual person. At the conclusion of the research, the information collected will be securely stored for 15 years minimum is accordance with ethics regulations. The discussions conducted by the research team will take around 45-90 minutes. We appreciate your other commitments and will fit with your schedule. You can participate in this study if you have been diagnosed to have GDM in your current or previous pregnancy. Participating in this study is completely voluntary and you do not have to take part. If you decide to take part in the study and then change your mind later, you are free to withdraw from the study at any time by informing us. Your decision whether or not to participate will not affect your current or future relationship with the researchers at any of the participating institutions and your doctor. However, we wish to inform you that due to the nature of group discussions it will not be possible to delete the information from audio recordings. In this case, any information already collected will be kept in our records and may be included in the study results. There would be no costs associated for being in the study. Aside from giving up your time, we do not expect that there will be any risks or costs associated with taking part in the health care consultation recording or interviews. If you take part in this evaluation you will not be paid to participate. This research is intended to better our understanding of ways to prevent or delay type 2 diabetes among the women diagnosed with gestational diabetes. The formative research is not associated with any financial benefits to the researchers or affiliated organisations. If you suffer any injuries or complications as a direct result of being in study, you should contact the study doctor as soon as possible, who will assist you in arranging the appropriate medical treatment. In such cases, to cover medical care and/or compensation in case of any such events the sponsor(s) holds insurance policies. If you have any questions concerning the availability of medical care or if you think you have experienced a research-related illness, injury or emergency, contact Dr. ___________________________ Phone: _________________________________ (Site level doctor details will be inserted later) You will not be paid for taking part in this study and there are no other financial benefits (direct or indirect). However, you will be reimbursed for reasonable travel expenses for the group discussion. (11) What will happen to information about me that is collected during the study? By providing your consent, you are agreeing to us collecting personal information about you for the purposes of this research study. Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise. The information collected during the formative phase of the study will be treated as strictly confidential and not released to anyone outside the research team, except as required by law. The information provided to the researchers will not include any personal information and will be identified by a unique study number only. Study findings may be published but you will not be individually identified in these publications. Yes, you are welcome to tell other people about the study. When you have read this information, a member of the research team will be available to discuss it with you further and answer any questions you may have. You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by ticking the relevant box on the consent form. Research involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of [to be replaced by relevant institution and protocol number]. As part of this process, we have agreed to carry out the study according to the Australian National Statement on Ethical Conduct in Human Research (2007) . If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. Telephone: +61 2 8627 8176 Email: ro.humanethics@sydney.edu.au Fax: +61 2 8627 8177 (Facsimile) If you have any complaints regarding the research you may also contact the Patient Representative at your hospital/ the member secretary of the overseeing ethics committee, whose contact details are provided below. India -Details of site specific hospital HRECs will be added later. I understand that I can withdraw from the study at any time. I understand that personal information about me that is collected over the course of this project will be stored securely and will only be used for purposes that I have agreed to. I understand that information about me will only be told to others with my permission, except as required by law. I understand that the results of this study may be published, and that publications will not contain my name or any identifiable information about me. The Lifestyle Intervention in Gestational Diabetes (LIVING) study is a randomised controlled trial (RCT) of a low intensity lifestyle modification programme tailored to women with GDM in India, Bangladesh, and Sri Lanka. The multiple interacting components of this complex intervention were informed by several successful studies in the prevention of T2DM and weight gain, which have been described elsewhere. The multicentre study will be undertaken over 60 months (December 2015 to December 2020). 1414 women with prior GDM will be recruited from a total of up to 24 hospitals in these three countries. The primary outcome of the randomised trial is the proportion of women with a worsening of glycaemic category at or prior to the final visit: (i) normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM; and (ii) IFG or IGT to T2DM. The secondary outcomes of the study include change in body weight, waist circumference, blood pressure, fasting blood glucose, physical activity level, and diet. The intervention comprises four face-to-face group sessions, 84 automated text or prerecorded voice messages, monthly phone calls, and two 'intensification' sessions in the event that weight goals are not achieved within six months of the commencement of the intervention. The LIVING study process evaluation conducted alongside the RCT will inform policy and decision makers about the reasons why and the mechanisms through which the intervention worked, and whether the intervention is likely to be generalisable and scalable in the real world contexts in which they work. Aims and objectives The overall aim of this process evaluation is to evaluate and understand what worked and why during the implementation of the LIVING intervention. In addition, this study aims to provide additional information that will assist in the interpretation of the LIVING study results. Specific objectives are as follows: i. Evaluate for whom the intervention was effective and why ii. Evaluate whether the intervention was implemented appropriately, and as planned iii. Evaluate whether the intervention is generalisable, scalable, and sustainable in a real world setting Methods and analysis Methodological approaches informing our evaluation framework The RE-AIM framework will be used to inform the LIVING study's process evaluation framework. The RE-AIM framework consists of five dimensions of health-related behaviour interventions: reach to the target population, effectiveness of the intervention, adoption by the intended recipients of the intervention, staff, and institutions such as hospitals, implementation (including consistency of implementation and costs), and maintenance of the intervention effects in specific settings over time. These five dimensions aim to encourage researchers, evaluators and policy makers to identify the elements of health interventions that improve adoption, implementation and sustainability. The RE-AIM framework was considered highly suitable as the LIVING programme was designed with the intention of broader adoption and implementation into policy and practice in the South Asian context and has been used to design our evaluation framework (Figure 1 ). The LIVING study process evaluation framework The evaluation framework ( Figure 1 ) demonstrates each of the intervention components and the relationships among them. Firstly, the framework incorporates the intervention components addressing assumed causal mechanisms. These causal mechanisms (explained in detail in our logic model [ Figure 2 ]) are intended to make it easier to understand why the intervention will work, and to facilitate external scrutiny of their plausibility. These assumptions are underpinned by the key elements of Michie's behaviour change wheel (capability, opportunity, and motivation). Thus, it also serves to test the applicability and robustness of the theory in the context of lifestyle change in women with prior GDM in India, Bangladesh, and Sri Lanka. Secondly, the framework incorporates implementation factors (e.g. reach and recruitment, fidelity and dose, as well as adoption and implementation), mechanisms of impact (e.g. effectiveness, acceptability, and maintenance) and finally, the outcomes of the trial (to be assessed at the end of the study). A mixed methods design will be used to investigate the components of our process evaluation framework. This will involve the integration of both qualitative and quantitative data in the research process including evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs filled at intervention sites, audit reports, quantitative participant evaluation surveys, semi-structured interviews, and focus group discussions. 1. Evaluation datasets: Data from participants will be collected at randomisation, and 6 monthly intervals thereafter, with Oral Glucose Tolerance Tests (OGTT) and HbA1c tests, alternately conducted at the follow-up 6 monthly visits, and both tests at the End of Study visit. 2. Administrative data: Monitoring (at least one every six months) will be conducted by central study staff to ensure compliance with the protocol, and any local requirements. During each visit, the study monitors will fill in a monitoring report on record maintenance, conduct of sessions, and implementation of the programme, and offer feedback to ensure consistency of the implementation. The voice/text messaging report will indicate the number of successful messages sent every month as well as whether the voice message was heard completely, or disconnected early. 3. Programme checklists and logbooks: Programme specific checklists were developed in conjunction with the research team records to assess implementation fidelity, recruitment, intervention delivery, and programme context. Intervention session logs documenting attendance, collection of feedback, and participation of group members will also be analysed. 4. Programme auditing: The delivery of the group sessions will be audited by direct observation, remote observation, or audio or video recording. These data will be analysed alongside the intervention session logs and checklists. At least one of the four sessions conducted for each group will be observed by monitors. The intervention facilitators' conduct of at least one instance of each of the four different sessions will be observed by monitors. 5. Quantitative participant evaluation survey: A barriers and facilitators evaluation survey, administered after the 4 th (and final) group session, at approximately 6 months after randomisation, will be undertaken to explore what women have found to be enabling and challenging in executing lifestyle modification following the group sessions. Surveys will list potential barriers to, and facilitators of, physical activity and healthy eating. Participants will also be able to list barriers and enablers that are not listed in the evaluation form. 6. Semi structured interviews: Semi-structured interviews will be conducted with a sub-group of participants, staff and stakeholders at the end of study. Interviews will also be conducted using a maximum variation sampling technique to ensure that diverse opinions are gained from healthcare workers, hospital administrators, and representatives of relevant government agencies with broad representation across the three countries. 7. Group session evaluation form: All women who attend group sessions will fill a feedback form at the end of each session. They will score their overall experience of the intervention session including feedback on intervention content, its presentation as well as facilitator's skills and behaviour. Below, we describe how each of the data collection tools listed within the evaluation framework will be used. The barriers and facilitators evaluation survey and group session feedback form will help us understand what aspects of women's lifestyle are preventing them from achieving changes, and which aspects of the intervention they found useful, e.g., self-motivation, weather, scheduling, social support, or information. The group session feedback form will explore whether the topics covered in the sessions were relevant to them, whether they felt the trainer was well prepared, whether the time allotted for the session was sufficient, and whether the content was organised and easy to follow. Evaluation datasets These data will be used to quantitatively evaluate effectiveness (e.g. percent change in outcome variables at the end of the trial). Data from case record forms used in initial and follow-up assessments will be used to compare characteristics of intensification and non-intensification participants to identify any trends in whom the intervention was most effective or least effective for. Semi-structured interviews with health workers, and implementers and monitors of the intervention (see annexure 5.1 for interview schedule), and semi-structured interviews or focus group discussions with participants (see annexure 5.2 for discussion schedule) will seek to gain a deeper understanding of the themes underpinning the surveys described above. In addition, they will seek to address the surveys' gaps (e.g. themes that participants raise in the surveys that were not listed by intervention developers in the pre-formulated survey tool). These data will contribute to a deeper understanding of what participants and the health workers delivering the intervention think the causal mechanisms are, as well as their general attitudes towards the intervention. The discussions will include a specific focus on how (from the perspectives of the participant and the health worker) the intervention impacts elements of Michie's Behaviour Change Wheel, that is, women's capability, opportunity, and motivation. In order to investigate the fidelity of the trial, i.e. whether the components of the trial were delivered as intended and in appropriate detail, this process evaluation will utilise mixed methods. Routine monitoring data (e.g. estimated number exposed to recruitment, percent screened for eligibility, percent ineligible for participation, actual number eligible, and actual number who participated) and evaluation datasets will be used to assess reach (whether the intended audience came into contact with the intervention, and how). To assess implementation, and whether poor implementation limited the effects of the intervention, we will use trial administration data pertaining to, for example, the actual number of phone calls, text messages received, and sessions attended. The observation checklist, data obtained from programme auditing, as well as other administrative data collection tools mentioned above will assess the management of group dynamics, the transmission and emphasis of key messages, the provision of all intervention materials, and the participation of the group members. In addition, pre-post assessment of facilitators will be undertaken to evaluate their training, and all facilitators will participate in a self-assessment wheel. We will use these data to understand how facilitators carried out their roles and responsibilities. These data will be supplemented with semistructured interviews with participants, and facilitators. The interviews will seek to understand, from various perspectives, issues of fidelity and dose. A third objective of this process evaluation will be to ascertain whether the intervention is generalisable and scalable. Our theoretical framework will allow researchers, evaluators, and policymakers to pinpoint how the intervention, with reference to the key components of each theory incorporated into our framework, can be scaled up in India, Bangladesh, and Sri Lanka as well as tailored to other contexts, if the intervention is found to be effective. Focus groups and semistructured interviews will be used to understand the barriers and enablers to implementation. In addition, they will seek to understand how the complex intervention was embedded in organisational contexts as the result of individual and collective work to implement the programme. We will investigate the extent to which the integration of the programme attracted continuous investment by people by working together, as well as how it might be expected that this will continue in the future, and in other contexts. Finally, using semi-structured interviews with key stakeholders in decision-making and management, we will enquire about the extent to which current guidelines, environmental social planning, fiscal measures, and legislation, regulation and service provision are conducive to the scale-up, and sustainability of the intervention at each site. Sampling Participants for the interviews will be recruited using maximum variation purposive sampling. Of the 1414 women diagnosed with GDM recruited for the study, approximately half will receive the intervention. 60-90 women with GDM will be recruited at each of the sites in the North India, South India, Bangladesh, and Sri Lanka regions. Evaluation data, session feedback, and data from the barriers and facilitators survey will be obtained from each of the participants in the intervention. For the semi-structured interviews, we will recruit 10-15 women from each of the four regions, arriving at a total of 40-60 interview participants. We will also recruit one facilitator, site investigator, project and hospital management staff, and policy maker from each of the four regions, totalling 20 interview participants. In total, we will recruit 60-80 interview participants. We anticipate that this sample size will be sufficient to achieve thematic saturation. In the event that thematic saturation has not been reached, we will increase our sample of interview participants. Participants will be recruited by the local site staff, and where relevant, reasons for not participating will be elicited. Written consent will be obtained for the discussions (see annexure 5.3 for Participant Information Sheet and Consent Form for intervention facilitators, site investigators, monitors, implementers, and other stakeholders, and annexure 5.4 for Participant Information Sheet and Consent Form for intervention participants). Analysis plan We will undertake thematic analysis of all qualitative data. Data analysis will be conducted contemporaneously with data collection until thematic saturation has been achieved. The development of the coding framework will be informed by the RE-AIM framework as well as the two theories (Michie's Behaviour Change Wheel, and Normalization Process Theory) that have informed our interview and discussion schedules. The analysts will establish themes, under the headings of the evaluation framework: context, causal mechanisms, implementation, mechanisms of impact, and outcomes. Given that the process evaluation is testing a hypothesised causal pathway (described in the logic model - Figure 2) , the analysis will aim to scrutinise the extent to which our logic model predicted the actual impact of the intervention, and also identify unexpected mechanisms. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders (e.g. auxiliary nurse midwives, participants, and management staff). Our analysis will identify components of the intervention, implementation, and outcomes associated with a large degree of agreement, as well as identify any differences in experiences and perspectives among stakeholders. Data from other sources listed in the framework (including administratively collected process data, and survey data) will be used to triangulate themes. Quantitative data will help inform fidelity and dose as described in the previous section. The framework will aid in triangulating qualitative and quantitative findings, as well as identifying the relationships among context, implementation, mechanisms of impact, and outcomes. Data analyses will be ongoing, and process data will be analysed independently of the outcome evaluation data before the two sets of data are combined. Data will also be triangulated, to increase the reliability of results, using the multiple perspectives of analysts (based in India, Bangladesh, Sri Lanka, and Australia) and the diverse disciplinary (social sciences, medical, legal), and cultural backgrounds of the analysts. In addition, at least one analyst (JS) has not been involved in the development of the intervention and as such, we anticipate that this independent perspective will help to triangulate data, and ensure the reliability of our results. Ethics and dissemination All participants for the process evaluation will be given information about the study, and their consent will be obtained. Relevant ethics approval will be obtained beforehand from the respective human research ethics committee of the All India Institute of Medical Sciences, Delhi, India; University of Sydney, New South Wales, Australia; and at each local site in the three countries, India, Bangladesh, and Sri Lanka. The findings of this process evaluation will be documented in academic publications, and presentations at scientific meetings. In addition, the findings will be presented and discussed during planned stakeholder workshops. The manuscript will be approved by the LIVING study Steering Committee prior to all publications or presentations. Trial status The trial was initiated in December 2015 and follow-up will be completed by the end of 2020. The recruitment of the sites, intervention development and its site-specific contextualization as well as the staff training is complete. Results will be reported at the end of 2021. Probes What are your views on the burden of gestational diabetes in India/Sri Lanka/Bangladesh? -Do you perceive this issue to be common? -What kinds of support exist (e.g. family, and community, health care settings and national or subnational programs) to help women with gestational diabetes? -What kind of support is available after delivery in women with gestational diabetes? -What is or should be the role of hospitals, primary health care centres in addressing gestational diabetes? What are your general attitudes towards the intervention? What are you general attitudes towards the: -Face-to-face group sessions -Voice/text messages -Monthly phone calls -Intensification sessions Evaluating whether and how the intervention had impact, for whom and why In your view, has the LIVING intervention motivated participants to make changes to their lifestyle? Evaluating whether the trial was implemented appropriately and as planned What has it been like for you to be involved in the LIVING study? -How has your involvement impacted your day-to-day work, and your institution (if relevant)? Were there any benefits or disadvantages for you or your institution? -Did you experience any problems with the general administration of the trial? If so, please explain. -In your view, has the intervention been delivered according the protocol? -In your view, have facilitator guidelines been followed by you and your colleagues? -What has been your experience of recruitment? What are your thoughts about the eligibility criteria? -How did you find follow-up with participants? -Have you experienced any problems in coordinating with other health workers involved in the study? -Do you have any thoughts about the primary outcomes of the study? -Has there been any contamination from the intervention to the control arm? Evaluating whether the results of the study are generalisable, scalable and sustainable? What has been your experience in embedding the LIVING program within your organisational context? -Did this require any changes to organisational practice or structure? -How have you and your colleagues worked individually and collectively to implement the program within your practice? o Were these efforts continuous and/or consistent? o In your view will you be able to continue these efforts into the future? The research study LIVING (Lifestyle InterVention IN Gestational diabetes) compares a low intensity post-childbirth lifestyle program to usual care among women diagnosed with Gestational Diabetes Mellitus (GDM) during their recent pregnancy. You were involved in the implementation of the intervention in the LIVING study. You are invited to take part in an interview that aims to explore your views on the benefits, disadvantages, and acceptability of this lifestyle modification program. From this interview, we will gather your perspectives on the intervention, which may be incorporated into the design and delivery of the intervention to optimise it for future implementation. This information sheet gives details of the interview planned. You will be given a copy of this information sheet to keep. If there is anything that is not clear, or if you would like to have more information, please do not hesitate to ask the study team. Once you understand the process evaluation, and if you have no objections to your involvement, you will be asked to sign the Consent Form. By signing the Consent Form you do not alter your legal rights, but you indicate that you understand the information and have no objection to participating in the process evaluation. (2) Who is running the study? In India, the study is being conducted by the All The interview will cover information about your views about the program. It will be conducted at a place of your convenience, either at the hospital or at your home. During an interview, if a question is asked that you do not want to answer, please say so. The researchers will then move on to another question. All interviews will be audiorecorded, and transcribed, and your name and personal details will be removed for analysis purposes. The data will be analysed by a small team of experienced researchers and will be stored on a secure, password-protected folder accessible only to the researchers. We seek permission to use quotes from your interview in our reports but none of this information will allow identification of an individual person. An interview will take between 45 and 90 minutes. We appreciate your other commitments, and will fit this in with your schedule. Individuals involved in the implementation of the LIVING study intervention can take part in this process evaluation. Your participation is voluntary and you are entirely free to decide whether or not to take part in this process evaluation. If you choose to take part, you are free to withdraw at any time, without giving any reason. If you choose not to take part, your legal rights will not be affected. Your decision whether to participate will not affect your current or future relationship with the researchers or any individuals or organizations related to this study. Data that can be withdrawn: If you wish, your information collected during the interview will be removed from our study records and will not be included in the study results, up to the point that we have analysed and published results. (7) Are there any risks or costs associated with being in the study? There will be no costs associated with participating in the process evaluation. This process will not involve use of any drugs, medications or procedures. The risks of participating include: (i) Giving up your time to participate in the study: This might cause some inconvenience but we will try to fit the discussions in to your schedule. (ii) Psychological discomfort during the discussion: There is a risk that a topic could be raised that you may find upsetting. If this happens, please say so. The recording of the interview will be stopped immediately. The interview and recording will only start again if you agree, and a different topic will be discussed. You might worry afterwards about something that you said in the discussion. There is no need for this as everything is treated in strict confidence. All the recordings and written records will be made anonymous. If you are still worried, you can contact the researchers to discuss your concerns. This study is not associated with any financial benefits to researchers and affiliated organisations. We will be only collecting information from you by asking few questions and you will not be exposed to any drug, medication or procedure. If you suffer any injuries or complications as a direct result of being in the study, you should contact the study investigator as soon as possible, who will assist you in arranging the appropriate medical treatment. In such cases, to cover medical care and/or compensation in case of any such events the sponsor(s) holds insurance policies. If you have any questions concerning the availability of medical care or if you think you have experienced a research-related illness, injury or emergency, contact Dr._________________________ Phone: ________________________________ (Site level doctor details will be inserted later) It is hoped that this process evaluation will contribute to the revision and refinement of the Type 2 diabetes mellitus prevention intervention for women who have had gestational diabetes mellitus. We cannot, however, guarantee that it will be of direct benefit to you. You will not be paid for taking part in this study. You will be provided refreshments at the discussion. All information collected about you will be kept strictly confidential. Your initials and date of birth will be used as identifiers in the study. Only study monitors, auditors, and the Ethics Committee will be granted direct access to your records for verification of study procedures and/or data, without violating your confidentiality, to the extent permitted by the applicable laws. By signing a written Informed Consent Form, you authorise such access. Study findings may be published, but you will not be individually identified in these publications. All records and data relating to the study will be destroyed in a secure manner, 15 years after the end of this study, while protecting your confidentiality. Yes, you are welcome to tell other people about the study. When you have read this information, a member of the research team will be available to discuss it with you further and answer any questions you may have. You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by ticking the relevant box on the consent form. You will receive a summary of the research study results after the study is finished. Research involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of [to be replaced by relevant institution and protocol number]. As part of this process, we have agreed to carry out the study according to the Australian National Statement on Ethical Conduct in Human Research (2007) . If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. The research study LIVING (Lifestyle InterVention IN Gestational diabetes) compares a low intensity post-childbirth lifestyle program to usual care among women diagnosed with Gestational Diabetes Mellitus (GDM) during their recent pregnancy. You are a participant in the intervention group in the LIVING study. You are invited to take part in a discussion that aims to explore your views on the benefits, disadvantages, and acceptability of the lifestyle modification program that you received. From this discussion, we will gather participants' perspectives on the intervention, which may be incorporated into the design and delivery of the intervention to optimise it for future implementation. This information sheet gives details of the discussions planned. You will be given a copy of this information sheet to keep. If there is anything that is not clear, or if you would like to have more information, please do not hesitate to ask the doctor or the study team. Once you understand the process evaluation, and if you have no objections to your involvement, you will be asked to sign the Consent Form. By signing the Consent Form you do not alter your legal rights, but you indicate that you understand the information and have no objection to participating in the process evaluation. (2) Who is running the study? In India, the study is being conducted by the All The discussion, which may be an individual interview or a group discussion, will cover information about your life and your health experience and views about the program. It will take approximately one hour and may occur at the same time as one of your study follow-up visits, or at a separate time, either at the hospital or at your home. Group discussions to discuss experiences with the intervention will usually include six to eight women. During an individual interview, if a question is asked that you do not want to answer, please say so. The researchers will then move on to another question. If a topic that you do not wish to discuss comes up during a group session, you do not need to contribute to that discussion. All interviews and group discussions will be audiorecorded, and transcribed, and your name and personal details will be removed for analysis purposes. The data will be analysed by a small team of experienced researchers and will be stored on a secure, password-protected folder accessible only to the researchers. We seek permission to use quotes from your interview in our reports but none of this information will allow identification of an individual person. Discussions conducted by the research team will take between 45 and 90 minutes. We appreciate your other commitments, and will fit this in with your schedule. Participants in the intervention group in the LIVING study can take part in this process evaluation. Your participation is voluntary and you are entirely free to decide whether or not to take part in this process evaluation. If you choose to take part, you are free to withdraw at any time, without giving any reason. If you choose not to take part, your medical care or legal rights will not be affected and you will continue to receive the usual care given by your doctors and other healthcare providers. Your decision whether to participate will not affect your current or future relationship with the researchers or any individuals or organizations related to this study. Data that can be withdrawn: If you wish, your information collected during individual interviews will be removed from our study records and will not be included in the study results, up to the point that we have analysed and published results. Data that cannot be withdrawn: Due to the nature of group discussions it will not be possible to delete the focus group discussion information from audio recordings. In this case, any information already collected will be kept in our records and may be included in the study results. There will be no costs associated with participating in the process evaluation. This process will not involve use of any drugs, medications or procedures. The risks of participating include: (i) Giving up your time to participate in the study: This might cause some inconvenience but we will try to fit the discussions in to your schedule (e.g., hospital visits). (ii) Psychological discomfort during the discussion: There is a risk that a topic could be raised that you may find upsetting. If this happens, please say so. The recording of the interview will be stopped immediately. The interview and recording will only start again if you agree, and a different topic will be discussed. If a topic that you do not wish to discuss comes up in a group discussion, you should avoid discussing it. You might worry afterwards about something that you said in the discussion. There is no need for this as everything is treated in strict confidence. All the recordings and written records will be made anonymous. If you are still worried, you can contact the researchers to discuss your concerns. This study is not associated with any financial benefits to researchers and affiliated organisations. We will be only collecting information from you by asking few questions and you will not be exposed to any drug, medication or procedure. If you suffer any injuries or complications as a direct result of being in the study, you should contact the study investigator as soon as possible, who will assist you in arranging the appropriate medical treatment. In such cases, to cover medical care and/or compensation in case of any such events the sponsor(s) holds insurance policies. If you have any questions concerning the availability of medical care or if you think you have experienced a research-related illness, injury or emergency, contact Dr._________________________ Phone: ________________________________ (Site level doctor details will be inserted later) (10) Are there any benefits associated with being in the study? You will have a chance to talk about your experiences, which you may find helpful. Participating in this discussion may not be of any other direct benefit to you. It is hoped that this process evaluation will contribute to the revision and refinement of the Type 2 diabetes mellitus prevention intervention for women who have had gestational diabetes mellitus. We cannot, however, guarantee that it will be of direct benefit to you. You will not be paid for taking part in this study. However, you will be reimbursed for reasonable travel expenses for study visits to the hospital, and provided refreshments at the discussion. (11) What will happen to information about me that is collected during the study? All information collected about you will be kept strictly confidential. Your initials and date of birth will be used as identifiers in the study. Only study monitors, auditors, and the Ethics Committee will be granted direct access to your records for verification of study procedures and/or data, without violating your confidentiality, to the extent permitted by the applicable laws. By signing a written Informed Consent Form, you authorise such access. Study findings may be published, but you will not be individually identified in these publications. All records and data relating to the study will be destroyed in a secure manner, 15 years after the end of this study, while protecting your confidentiality. Yes, you are welcome to tell other people about the study. When you have read this information, a member of the research team will be available to discuss it with you further and answer any questions you may have. You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by ticking the relevant box on the consent form. You will receive a summary of the research study results after the study is finished. Research involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of [to be replaced by relevant institution and protocol number]. As part of this process, we have agreed to carry out the study according to the Australian National Statement on Ethical Conduct in Human Research (2007) . If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. This statistical analysis plan (SAP) describes the statistical methods and data presentations to be used in the summary and analyses of data from Lifestyle Intervention in Gestational Diabetes (LIVING) study. This document is based on the Protocol for LIVING, A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus, Version 6.0 dated May 13, 2020. It describes the final analyses. The document should be finalised before database lock and unblinding. The LIVING study aims to determine whether a resource-and culturally appropriate lifestyle intervention program in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycemic status in a manner that is affordable, acceptable and scalable. The study is an open-label parallel group pragmatic individual randomised controlled trial with blinded primary endpoint adjudication. Eligible women were randomised to receive either usual care or the intervention in a 1:1 ratio. Following randomization, study visits captured data at months 6, 12,18, 24, 30, 36, 42 and 48 or up to the end-of-study (EOS) visit. All participants were required to have a minimum of 12 months follow-up. All EOS visits were scheduled between July 1 st 2020 and January 31 st 2021 The study is conducted in 20 sites in India, Bangladesh and Sri Lanka. Absence of Type 2 diabetes mellitus (T2DM) at 3 to 18 months post-partum oral glucose tolerance test (OGTT). Met criteria for trial registration: o GDM diagnosed 24-34 weeks gestation through OGTT and using International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria or by other criteria outlined in the study protocol if OGTT was performed before 24 weeks of gestation or only a fasting plasma glucose level was obtained prior to 24 weeks gestation. Confirmed case of T2DM Travel time to hospital more than 2 hours (unless individual circumstances will not impede hospital attendance for study visits) Lack of access to a mobile telephone Use of steroids during pregnancy other than for lung maturation of the baby Randomisation occurred through a central, computer-based randomisation service, and was stratified by country, centre and use of insulin during pregnancy. By necessity, neither site investigators nor participants was blinded to allocation (intervention vs. usual care). However, all central study staff, statisticians, and outcome adjudicators were and will remain blinded until final database lock. A sample size of 1414 women with GDM will provide 90% power (2α=0.05) to detect a relative risk of 0.65, assuming that the control group cumulative incidence for change in glycaemic category will be 20% at 24 months and allowing for 20% of missing outcome data. The initial power calculation was based on a chi-square test comparing two proportions at 24 months; however, to account for various study durations, the primary analysis will consist in a survival analysis of time to change in glycaemic category which is expected to have at least the same power as a comparison of proportions. The following 11 subjects were mis-randomised and will be excluded from the ITT analyses: S103023, S103137, S103139, S104012, S106008, S207007, S207012, S207021, S207026, S207031 and S416335. All analyses will be based on the principle of intention-to-treat, i.e. by analysing subjects according to the group they were randomised to and regardless of compliance. The ITT will include all enrolled subjects who are randomised and have a baseline with respect to the efficacy evaluation of this study. Mis-randomised subjects will not be part of the ITT analysis. Analyses of the primary and secondary outcomes will be repeated after including the 11 misrandomised subjects. This will be indicated in the relevant sections of this SAP. The last data available recorded at or prior to the randomisation visit will be used as baseline values unless otherwise specified. Given study participants entered the study at different times and were followed for various durations, the End of Study (EOS) visit will occur at different times for different participants. For longitudinal analyses and descriptive analyses by visit, EOS visits will be re-allocated according to the planned visit schedule (i.e. Month 1, 6, 12, 18, 24 or 30). The allocation, based on the number of days between the date of randomisation and the EOS visit, will be done as follows: Early termination is captured on the CRF and may be due to one of the following reasons: Withdrawal of Informed consent for follow-up visits Development of T2DM Occurrence of pregnancy Unable to contact or unable to follow-up In case of early termination, a patient was expected to have an EOS visit completed at the time of termination. For those who did not terminate early, EOS visits with at least partial data collection were to be conducted after 1 July 2020. All durations (e.g. time to event) will be calculated relative to the date of randomisation, if not specified otherwise. Age will be calculated from the Date of birth to date of randomisation. For analyses of age involving patients who were not randomised, age will be calculated using the date of informed consent instead of the randomisation date. Physical activity will be measured in terms of Metabolic Equivalent for Task (MET) derived from the Global Physical Activity Questionnaire (GPAQ). The total number of METs in a typical week will be used as secondary outcome. Other measures of physical activity, not considered as secondary outcomes, include: Hours of moderate physical activity (total hours per week) Sedentary hours (time spend sitting or reclining) (average hours per day) Hours of sleep (average hours per night) Diet will be measured as the total calorie intake derived from the INTAKE 24 questionnaire. It is calculated as follows: Calories from carbohydrate = 4 x grams of carbohydrate Calories from protein = 4 x grams of protein Calories from fat = 9 x grams of fat Total calorie intake = calories from carbohydrate + calories from protein + calories from fat The calculated total calorie intake will be used as secondary outcome. Other measures of diet, not considered as secondary outcomes, will include: Protein intake (grams) Carbohydrate intake (grams) Fibre intake (grams) Fat intake (grams) Sodium intake (grams) Serious Adverse Events (SAE) and Concomitant Medications (CM) will be categorised by medical experts who will provide corresponding standard terms for free texts used for both SAE and CM. Coding will be performed while blinded to the treatment allocation. The number of patients with available data will be reported. Missing or incomplete data will not be substituted/imputed, except where explicitly stated throughout the SAP. Listings will be sorted by unique subject identifier and analysis time point and/or date if applicable. Dates will be formatted as DDMMMYYYY. Partial dates will be presented on data listings as recorded on CRFs. Rounding for all variables will occur only as the last step, immediately prior to presentation in listings and tables. No intermediate rounding will be performed on derived variables. The standard rounding practice of rounding numbers ending in 0-4 down and numbers ending 5-9 up will be employed. Every table, listing and figure will be produced with an electronic date stamp to document when it was produced. Double programming by 2 independent Statisticians/Statistical programmers will be done on all key analyses. Double programming may be replaced by code review if need arises. Discrepancies and/or data handling decisions will be adjudicated by a third statistician without access to the impacted results. Analyses will be performed using SAS Enterprise Guide version 8.3 or higher (SAS Institute Inc., Cary, NC, USA). All variables will be analysed by descriptive statistical methods. The number of data available and missing data, mean, standard deviation, minimum, quartiles, median, and maximum will be calculated for continuous data. Frequency tables will be generated for categorical data. For categorical variables, the number and percentage of patients with a specific level of the variable will be presented. All tests will be two-sided with a type-I error rate of 5%. Analyses of the primary outcome (change in category of glycaemia from normoglycaemia to IGT, IFG or T2DM or from IFG or IGT to T2DM) will be unadjusted for multiplicity; however, we will control the family-wise error rate across secondary outcomes using a Holm-Bonferroni correction [2] . No other multiplicity adjustment will be applied. No interim analysis was conducted. The flow of subjects through the trial will be described using a Consort diagram (see Figure 1 ). Screening failures will be listed together with the reason for their exclusion from study and all available data (Date of informed consent, Reason for screen failure, Date of last visit). At each visit, we will tabulate the number and proportions of patients according to the following categories: Whether the visit took place (yes vs no) Reason for no assessment (e.g. early discontinuation, LTFU) -see Section 3.5 Visit type (in hospital, at home, by telephone) Oral glucose tolerance test (OGTT) data available when expected (yes or no) Haemoglobin A1c (HbA1c) data available when expected (yes or no) Fasting blood glucose (FBG) data available when expected (yes or no) The following variables will be summarized at baseline: The intervention will be summarised in terms of number of visits, type of visit (face-to-face, online or telephonic or other), if session was in group or individually, and other relevant details. Given the complexity of the intervention and the fact that it only applies to participants randomised to the intervention group, compliance will be defined and summarised after we have analysed the details of the intervention. To assess the potential effect of compliance, we will consider performing a complier average causal effect (CACE) analysis using both a propensity-weighted approach and a joint modelling approach [2] . Categories of medications (e.g. blood pressure lowering, nutritional supplements) will be defined during the blind review. The number and proportion of patients taking a medication from each category at least once during the study will be reported. Differences in proportions between groups will be tested using Fisher's exact test. Descriptive statistics will be presented for all diet and physical activity variables described in Sections 3.7 and 3.8 by visit and randomized group. In addition longitudinal mean plots and repeated-measure generalised linear mixed models will be used to assess differences between groups over time as described in Sections 4.10.1 and 4.10.2. More detailed analyses will be considered in secondary papers and are not described in this SAP. The number of events as well as the number and proportion of participants accessing each service (e.g. hospital, pharmacy, etc.) at least once during the study will be reported overall and by treatment group. Differences in proportions will be tested using Fisher's exact test. More detailed analyses of healthcare utilisation including costs will be conducted later and are not described in this SAP. The primary outcome is a change of glycaemic category, at or prior to final visit defined as: A change from Normal glucose tolerance (NGT) to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or T2DM A change from IFG or IGT to T2DM This will be diagnosed using ADA criteria as given below: Normal glucose tolerance (<100 mg/dL fasting and <140 mg/dL post-glucose load) Impaired glucose tolerance (<100 mg/dL fasting and 140-199 mg/dL post-load) Impaired fasting glucose (100-125 mg/dL fasting and <140mg/dL post-load) Type 2 diabetes (≥126 mg/dL fasting or ≥200 mg/dL post-load) The number and proportion of subjects in each glycaemic category will be reported by group and by visit according to the six following categories: 1) Normoglycaemia 2) IFG 3) IGT 4) IFG + IGT 5) T2DM 6) Unknown glycaemic status This will be done both using a table and a stacked bar chart. Change in glycaemic category for primary outcome as defined in section 2.4.1 will be analysed as a time to event calculated as the number of days between randomisation and the day of the event. For subjects with no event, data will be censored on the day of the last OGTT test results. Survival by treatment arm will be described using a Kaplan-Meier plot with 95% confidence interval will be reported by treatment arm. If available, median time to event as well as quartiles will be derived from the Kaplan-Meier estimates. Censoring will be done at time of last OGTT test. A Cox model will be used to estimate the Hazard ratio of the two arms (Intervention compared to Control). The Cox model will include the randomised group as well as prior use of insulin as fixed effects and study site as a random effect [4] . We will visually assess the proportional hazard assumption. SAS Proc PHREG will be used. We will conduct a sensitivity analysis of the primary endpoint using Poisson regression i.e. using a generalised linear mixed model assuming a Poisson distribution and a Log link. The dependent variable will be a binary indicator (yes vs no) indicating whether the primary outcome occurred for each subject. Covariates will include the randomised group and prior use of insulin as fixed effects and a random effect of study site. The model will adjust for exposure (in years) defined as time to event or censoring, using the same definition as the one used for the survival analysis. The Poisson model will be used to estimate the yearly event rate and 95% confidence interval in each group. The effect of the intervention will be estimated as the rate ratio and its 95% confidence interval. SAS GLIMMIX procedure will be used. Both the Cox and Poisson models will be repeated after adding the following covariates to the model: prediabetes (yes/on), BMI (underweight, normal, overweight, obese), time since GDMaffected pregnancy (as a continuous variable, measured in months) and age (as a continuous variable, measured in years). The Cox and Poisson models described in sections 4.9.2 and 4.9.3 will be conducted according to the following baseline subgroups: Baseline glycaemic status: prediabetes vs normoglycaemia Gravida: 1 vs >1 Country: Bangladesh, India, Sri Lanka Body mass index (BMI): underweight (<18), normal (18) (19) (20) (21) (22) (23) (24) (25) , overweight (>25-30), obese (>30) Insulin use in index pregnancy: yes vs no Time since GDM-affected pregnancy: above vs below or equal to median Age: above vs below or equal to median This will be done by adding the corresponding subgroup variable to the main Cox and Poisson models as a fixed effect together with its interaction with the randomised group. Heterogeneity by subgroup will be quantified by the p-value associated with the interaction term. Results will be presented on forest plots. Analyses described in Sections 4.9.1, 4.9.2 and 4.9.3 will be repeated while using FBG and HbA1c values where an OGTT was not performed as scheduled during a follow-up visit. Censoring will occur at the time of the last relevant measure of glycaemia. For visits where an OGTT was performed, glycaemic categories will be defined according to the definition of Section 4.9. Otherwise, the following hierarchical approach will be used: Secondary outcomes include the following variables: Development of T2DM Fasting blood glucose Body weight Waist circumference Systolic blood pressure Physical activity level defined as the average daily MET (see definition in Section 3.7) Diet defined as the total 24-hour calorie intake (see definition in Section 3.8) Development of T2DM will be analysed in the same way as the primary outcome, i.e. using survival analysis and Poisson regression as described in sections 4.9.2 and 4.9.3. No adjusted or subgroup analyses will be applied to this outcome except for a subgroup analysis according to baseline glycaemic status (normoglycaemia vs pre-diabetes). Each continuous secondary outcome (i.e. all but development of T2DM) will be summarised by visit for each group and overall using mean, standard deviation, median and quartiles. Longitudinal plots will be used to display raw means and 95% confidence intervals by randomised group and by visit. Repeated-measure generalised linear mixed models will be used to assess differences between groups over time for all continuous secondary outcomes. Models will include the randomised group, the visit and the group by visit interaction, use of insulin during pregnancy and the baseline value of the outcome as fixed effects. Random intercepts by subject and by study centre will be added to the model. Within-subject correlations as well as within-site correlations will be assumed to follow an exchangeable structure. The effect of the intervention will be estimated as the adjusted mean difference at each visit and overall (all visits combined) together with its 95% confidence interval. A p-value from the likelihood ratio test will only be calculated for the overall difference based on all visits combined. Missing data will not be imputed; however, any subject with at least one post-baseline value will be included in the longitudinal models. Continuous measurements not already included as primary or secondary outcomes include HbA1c, heart rate and hip circumference. All will be analysed using the same approach as the one applied to secondary outcomes (see Sections 4.10.1 and 4.10.2). Serious Adverse Events (SAE) will be categorised during a blind review (see Section 3.9). Events will be summarised as the number of events as well as the number and percentage of subjects experiencing a given event at least once by category and by treatment arm. Differences in the proportion of subjects experiencing a category of event at least once will be tested using Fisher's exact test. Notes: Estimates obtained from a repeated-measure linear mixed model including the randomised group, the visit and the group by visit interaction, use of insulin during pregnancy and the baseline value of the outcome as fixed effects. Random intercepts by subject and by study centre will be added to the model. Within-subject correlations as well as within-site correlations will be assumed to follow an exchangeable structure A consort diagram showing the number of subjects screened, registered and randomised together with key data (e.g. OGTT, HbA1C and FBG) at each visit will be shown as in the Figure below extracted from the UMPIRE paper. Note: This figure will consist of a stacked bar chart with one bar per visit and the following four categories (summing to 100% within each bar): normal glycaemic status, pre-diabetes, T2DM or unknown status. Each group will be on a separate panel with both panels presented side by site. The figure will be repeated using 6 categories i.e. by splitting the 'pre-diabetes' category into the 3 following: (i) IFG only (ii) IGT only (iii) IFG + IGT. Show n and % in each category on the plot. Measure height, weight, waist circumference, and blood pressure Administer diet and physical activity questionnaires Record healthcare utilisation since delivery Six month visits Measure weight, waist circumference, and blood pressure Determine whether an interim diagnosis of T2DM has been made If an interim diagnosis of T2DM has been made, obtain confirmatory source documentation. The participants will not be followed up further, and will be discontinued from the study intervention. Data will be censored for these participants At Months 6, 18, and 30, perform HbA1c. If value is more than 6.5%, then call patient for OGTT At Months 12, 24 and 36, perform OGTT, unless an interim diagnosis of T2DM has been made, and source documentation is available. Participants who change glycaemic category Administer diet and physical activity questionnaires End of study) Measure weight, waist circumference, and blood pressure Determine whether an interim diagnosis of T2DM has been made If an interim diagnosis of T2DM has been made, obtain confirmatory source documentation If an interim diagnosis of T2DM has not been made, perform OGTT and measure HbA1c Administer diet and physical activity questionnaires Prevalence of diabetes in pregnant women--a study from southern India Prediction of gestational diabetes mellitus at 24 to 28 weeks of gestation by using first-trimester insulin sensitivity indices in Asian Indian subjects Gestational diabetes mellitus manifests in all trimesters of pregnancy Prevalence of gestational diabetes mellitus in Kashmiri women from the Indian subcontinent Global estimates of the prevalence of hyperglycaemia in pregnancy Inadequacy of the risk factor based approach to detect gestational diabetes mellitus Prevalence and trends of the diabetes epidemic in South Asia: a systematic review and meta-analysis Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions The conversion of gestational diabetes mellitus to future type 2 diabetes mellitus and the predictive value of HbA1c in an Indian cohort High prevalence of diabetes and impaired glucose tolerance in India: National Urban Diabetes Survey Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and metaanalysis Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1) Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study Normalisation process theory: a framework for developing, evaluating and implementing complex interventions The behaviour change wheel: a new method for characterising and designing behaviour change interventions Qualitative research practice: A guide for social science students and researchers Contributors to the statistical analysis plan Early study discontinuation/Lost to Follow-up Exposure to the intervention Analysis of the primary outcome Sensitivity analyses using HbA1c and A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial Assessing the sensitivity of methods for estimating principal causal effects A simple sequentially rejective multiple test procedure Accounting for centre-effects in multicentre trials with a binary outcome -when, why, and how xxx.Notes: Estimates obtained from a repeated-measure linear mixed model including the randomised group, the visit and the group by visit interaction, use of insulin during pregnancy and the baseline value of the outcome as fixed effects. Random intercepts by subject and by study centre will be added to the model. Within-subject correlations as well as within-site correlations will be assumed to follow an exchangeable structure