key: cord-0262890-g2816yv3
authors: Badri-Fariman, S.; Pourghassem-Gargari, B.; Badri-Fariman, M.; Pourfridoni, M.; Daneshi-Maskooni, M.
title: The Relationship Between Food Security and Dietary Patterns Status with COVID-19 in Northeastern Iran: Protocol for a Case-Control Study
date: 2021-10-26
journal: nan
DOI: 10.1101/2021.10.20.21265103
sha: e28b53ce033a210623ee3b7fc0217ead902cb1ea
doc_id: 262890
cord_uid: g2816yv3

Background: Food insecurity is defined as the limited or uncertain availability of enough food for a consistently active and healthy life. COVID-19 is a highly transmissible viral infection with high mortality due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and, or the uncommon severe pneumonia. This study assesses the relationship between food security and dietary patterns status with COVID-19 in the North Khorasan province, Iran. Methods: This case-control study will be conducted in the men and women aged 20-60 years improved from COVID-19 infection. The cases (n=124) and controls (n=124) were selected according to the eligibility criteria, including recently improved COVID-19 according to the positive COVID-19 PCR test. People referred to public and private laboratories or employees of public and private factories, offices, and departments of hospitals and universities (for the cases) and negative PCR tests without any clinical signs of COVID-19 infection (for the controls). The North Khorasan province was the target place. The groups are matched for age, sex, and body mass index (BMI). The assessments will include anthropometric measurements and general demographic, USDA 18-item food security (18item-FSSM), and 147-item food frequency (FFQ) questionnaires. Finally, the determination of the relationship between food security and dietary patterns status and associated socioeconomic factors with COVID-19 is done. P-value will be <0.05. Discussion: This study would be the first assessment of the relationship between food security and dietary patterns status with COVID-19 disease. It may help planners and policymakers to manage food insecurity and unhealthy dietary patterns and later increasing the immune system and decreasing the incidence of COVID-19. Further studies are suggested. Keywords: Case-control protocol study, COVID-19, Food security, Dietary pattern, Northeastern Iran

other abnormal causes such as acute respiratory distress syndrome, acute heart injury, and

RNAemia that can lead to death (1) (2) (3) (4) . COVID-19 is a highly transmissible viral infection with total mortality due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (5) . The most common symptoms at the onset of the disease are fever, cough, and fatigue, while other symptoms include sputum production, headache, diarrhea, shortness of breath, and lymphopenia (4) . The relative incidence of severe cases is about 20%, and mortality is approximately 3% (6) . The WHO estimates that seasonal flu alone worldwide causes 3-5 million cases of severe illness each year that requires hospitalization and 290,000-650,000 deaths, and overall, acute respiratory diseases estimated 2.38 million deaths worldwide in 2016 (7) . Severe lower respiratory tract infections were the most common cause of death from sepsis from 1990 to 2017 worldwide (6) . According to recent studies, COVID-19 is associated with increased production of pro-inflammatory cytokines, reactive protein C, increased risk of pneumonia, sepsis, acute respiratory distress syndrome, and heart failure (2).

The COVID-19 epidemic is perhaps the most significant global health crisis of our time, with unprecedented human challenges. One of these challenges is food insecurity. More than 820 million people went to bed hungry even before the COVID-19 epidemic, of which 110 million lived in acute food insecurity (United Nations, 2020).

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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. without sufficient financial resources may turn to cheap, low-nutrient foods to buy food (8) .

For this reason, food insecurity can be defined as limited or uncertain access nutritionally to adequate and safe food or limited or uncertain ability to gain acceptable foods in socially acceptable ways (9) . The range of food insecurity varies from anxiety about access to food at the household level to a high degree of hunger among children who have no food to eat (10) .

Food insecurity can be chronic, seasonal, transient, or at the level of household, region or nation and is a complex and multidimensional phenomenon that in addition to quantity and quality, also includes social, cultural and psychological dimensions (11) . It is not limited to people who do not have enough energy and nutrients, but also occurs when people do not have the right to choose food, are afraid of running out of food, or make significant changes in their food preferences (12) . Food insecurity may trigger a complex cycle of poorer dietary intake and compensatory overconsumption of poor quality foods, predisposing an individual to increased metabolic risk. Furthermore, food insecurity rises household stress, forces tradeoffs between food and medical care, increases the risk of medication non-adherence, and leads to poorer chronic disease self-management, all-important pathways toward worse metabolic and chronic disease outcomes (13) . So what food insecurity at the household level and the individual is a social disease with obvious health consequences (14) . It is known that in the general population, food insecurity and chronic conditions are associated with risk factors for chronic disease. Food insecurity, inadequate intake of essential nutrients, impaired development of mental, psychological, and behavioral dysfunction in children and adults and is associated with decreased resistance to disease. The inability to buy nutritious and adequate food and the resulting psychological and emotional stress can have adverse health effects or All rights reserved. No reuse allowed without permission.

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The copyright holder for this preprint this version posted October 26, 2021. ; https://doi.org/10.1101/2021.10.20.21265103 doi: medRxiv preprint exacerbate illnesses caused by other risk factors. Food insecurity is indirectly associated with obesity, high blood pressure, and impaired lipids, and blood sugar (15, 16) . Chronic food shortages lead to nutritional deficiencies, loss of food diversity, and low power modes that affect the ability of physical activity. In addition, the risk of high blood pressure increases due to the presence of high sodium and low potassium elements in highly processed, inexpensive foods. As well as lack of food may also lead to an inability to maintain hydration (17) . In addition, food insecurity is a physiologically stressful and emotional condition. This stress leads to an increase in cortisol, which is associated with an increase in the accumulation of body fat (incredibly visceral fat), which is a risk factor for diabetes and cardiovascular disease (18) . Asia has less than half the prevalence of food insecurity, according to the US Economic Search Service, and according to recent meta-analyses, the prevalence of food insecurity in Iran is 49% (19, 20) . Income is a determining factor in food insecurity and hunger. Special events that affect the household budget such as job loss, not having a permanent job, increasing family members or loss of food aid, as well as factors that affect diet such as ethnicity, differences in eating habits in various regions, and age and education of the head of the household are effective in creating food insecurity (21) . In separate studies in the world and Iran, the relationship between food insecurity and diseases such as obesity, reduced disease resistance, hyperlipidemia, diabetes, mental retardation, premenstrual syndrome, acne, depression, gastrointestinal cancer, upper extremities, osteoporosis, starvation, malnutrition, weakened immune system and reduced quality of life (9) .

Also, in recent years, a lot of attention has been paid to dietary patterns. Because dietary patterns take into account the internal relationships between dietary compounds while maintaining the diversity of all food intake and by using this method, people's nutritional behavior, which is a broad picture of food and nutrient intake, can be better reflected All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. considered a method that can show more aspects of the relationship between diet and infectious diseases. The dietary pattern of the populations is different due to geographical differences, socio-economic status, the culture of eating habits. Therefore it is necessary to do it separately in each place, while the passage of time creates the need for new study (22) .

The role that nutrition plays in supporting the immune system has been well established. A wealth of clinical data suggests that the supply of calories, proteins particularly essential amino acids and vitamins, including vitamins A, B6, B12, C, D, E, and folate. Trace elements such as zinc, iron, selenium, magnesium, copper, and omega-3 fatty acids, eicosapentaenoic acid, and docosahexaenoic acid play an essential complementary role in supporting the immune system. Bad consumption of these nutrients is overall, leading to reduced resistance to infections and therefore an increased burden of infectious diseases. Inadequate consumption of these nutrients is widespread, leading to reduced resistance to infections and thus an increased burden of infectious diseases (7) .

According to the recent pandemic of COVID-19 based on the statistics of the WHO and the relationship between food insecurity and the occurrence of malnutrition and its subsequent effects on weakening the immune system and increasing the risk of infectious diseases.

This study will aim to compare the food security and dietary patterns status with the possibility of developing COVID-19 symptoms in newly improved patients and non-infected individuals.

1) To determine and compare food security status in groups of people improved from COVID-19 and those who non-infected. All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 

We are determining and comparing independent quantitative and qualitative variables (household size, number of living children, employment status, household economic status, being covered by support organizations, receiving food aid, homeownership status, education status, race or ethnicity, and blood groups) in Groups of people improved from COVID-19 and non-patients.

Study design and Setting: The design of this study will be a case-control study which will be performed on men and women aged 20-60 years living in North Khorasan province, Iran, in a 1:1 ratio between case and control groups. Participants will be selected according to the study criteria from among those who refer to public and private laboratories, employees of offices, factories, administrative departments of universities, and hospitals. To minimize bias, case and control groups will be matched for the age (every ten years), gender (male and female), and body mass index (BMI) (as defined by the WHO; lean (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. To prevent possible errors and to ensure the accuracy of the test result, in general questionnaires completed by individuals in the case and control groups, will be asked questions such as specific and non-specific symptoms of COVID-19 such as gastrointestinal symptoms, respiratory symptoms, fever, lack of sense of smell and Taste, dry cough, etc.

• Pathologically confirmed COVID-19 (group of people improved by COVID-19) • Observe the symptoms of COVID-19 during the study • People who have not answered more than half of the food frequency questionnaire • People whose total daily energy intake is less than or more than three standard deviations from the average energy Variables assessed in this study: Variables evaluated in this study, include anthropometric assessments, general demographic questionnaires, USDA 18-item food security questionnaire All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (item-FSSM18), and a valid 147-item food frequency questionnaire (FFQ) based on face-toface interviews by a researcher and a colleague of a senior nutrition expert.

The usual nutritional intake will be assessed using a valid and reliable 147-item semi-quantitative food frequency questionnaire (FFQ) (23) (24) (25) . Trained dietitians, researchers, and a colleague of a senior nutrition expert will be asked the participants to report their intake frequency for each food item consumed during the past year in terms of the day, week, month, and year. The reported frequency according to the desired serving size of each food item or household measure will be converted into grams per day (26) .

Information on food security during the last 12 months using a validated and reliable food insecurity questionnaire that includes 18 questions and its validity and reliability has been confirmed (27) by conducting a face-to-face interview by a researcher and a colleague of a senior nutrition expert collected. Rating of 18-item USDA household food security status questionnaire is that is given positive rate to answers "often true," "sometimes true," "almost every month," "some months," and "yes" and zero score to responses "not true," "does not know or refused," "only 1 or 2 months", and "no." Finally, scores 0-2 in the secure food group, 3-7 in the insecure food group without hunger, 8-12 in the insecure food group with moderate hunger, and 13 and higher in the insecure food group with severe hunger are situated (28) .

Anthropometric measurements: Weight, height, and waist circumference are determined by using a digital scale, stadiometer, and none elastic tape, respectively. They are measured thus: weight without shoes, with minimal clothing, and with a 100-g accuracy; height without shoes, standing, heels against the wall, flat and forward head, and with 0.5-cm accuracy; and waist circumference with minimal clothing, midway between the last rib and the iliac crest.

Other assessments: Demographic and socio-economic information of this study using a demographic questionnaire including age, level of education, marital status, employment All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted October 26, 2021. ; https://doi.org/10.1101/2021.10.20.21265103 doi: medRxiv preprint status, family economic status, number of children, ethnicity, blood type, receiving food aid, covered by health insurance and support organizations Being, medical history and taking dietary supplements will be collected. Also, this questionnaire has two more questions for the case group than the control group. These two questions include the length of time since the disease and the state of recovery from the illness (recovery and quarantine at home or hospitalization and recovery in the hospital or hospitalization and recovery in the ICU).

Statistical data analysis will be performed using SPSS software (version 16.0; SPSS Inc., Chicago, IL, USA). Mean, and standard deviation will be used to describe quantitatively continuous and discrete variables. The Kolmogorov-Smirnov test will be used to test the normality of quantitative data. Independent t-test will be used to compare the mean of standard quantitative variables between case and control groups and Mann-Whitney test will be used to compare the mean of abnormal quantitative variables between case and control groups. Also, Chi-square and Fisher tests will be used to compare the distribution of qualitative variables among the groups. The significance p-value will be less than 0.05.

The sample size: First, a pilot study to get acquainted with the research environment, how patients respond to questionnaires, changes needed General questionnaire of demographic characteristics and socio-economic factors, determining the number of samples and the accuracy of the study was conducted. According to this pilot study performed on 13 patients recovering from COVID-19 whose positive PCR test was confirmed by Esfarayen Central Laboratory, the percentage of food insecurity was 69% (P2 = 0.69) and based on the pilot study performed on 13 people who had never had COVID-19 and whose PCR test result was negative were 46% (P1 = 0.46). Then, the sample size was calculated 124 cases and an equal number of controls with 5% drop, 95% power, and 95% confidence interval and using the following formula: All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 

This study is the first case-control interview-based study to examine the food security status and dietary patterns of individuals in the case group (improved by COVID-19) and the control group (individuals who have never had a COVID-19 infection). The practical purpose of this project is to provide information to planners to design the next steps in reducing food insecurity, modifying the diet, and using the appropriate diet, boosting the immunity system, reducing the incidence of COVID-19 infection, and perhaps other infectious and viral diseases.

The study's strengths are case-control design, protocol publication, and the assessment of dietary patterns and food security status.

The study's limitations are self-reporting of dietary intakes, and lack of cooperation of some patients in the end, which may lead to patients being replaced.

This study would be the first assessment of the relationship between food insecurity and dietary patterns status with COVID-19. It can help planners and policymakers manage food insecurity and poor and inadequate nutritional intakes. It may boost the immune system and decrease the incidence of viral or bacterial infections, especially COVID-19. Further studies are suggested.

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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. obtained from all the participants. Participation is free, and a patient can withdraw at whatever point the person feels they are unable to continue. There is no bar to receiving the other health care services of the center. The personal information of participants will be kept secret before, during, and after the study.

-Consent for Publication: Not applicable.

-Availability of Supporting Data: The datasets used and, or analyzed during the current study are available from the corresponding author on a reasonable request.

There is no potential conflict of interests for research, authorship, and publication.

-Funding: Not applicable.

-Authors'Contributions: SBF, BPG, and MDM conceived and developed the idea for the study and writing the original draft. MBF contributed to data collection. MP has contributed to the review and editing of the draft. All authors read and approved the final manuscript.

-Consent to Publish: Not applicable.

-Acknowledgements: This MSc thesis was supported by the Tabriz University of Medical

Sciences. The cooperation of the Jiroft University of Medical Sciences is acknowledged.

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