Digital Health/Social Media 4044 A Cardiovascular Health and Wellness Mobile Health Intervention Among Church-going African-Americans: Formative Evaluation of the FAITH! App LaPrincess Brewer1, Ashok Kumbamu2, Christina Smith1, Sarah Jenkins1, Clarence Jones3, Sharonne Hayes2, Christi A. Patten2, Lisa A. Cooper4, and Lora Burke5 1Mayo Clinic; 2Mayo Clinic College of Medicine; 3Hue-Man Partnership; 4Johns Hopkins University School of Medicine; 5University of Pittsburgh OBJECTIVES/GOALS: To evaluate the FAITH! (Fostering African- American Improvement in Total Health) App mHealth lifestyle intervention by using post-intervention feedback obtained from par- ticipants in our intervention pilot study. METHODS/STUDY POPULATION: We used qualitative methods (focus groups) to elicit post-intervention feedback. Participants who completed the pilot study were recruited to one of two focus groups. Semi-structured focus groups were conducted to explore participants’ views on the app functionality, utility and satisfaction as well as its impact on healthy lifestyle change. Sessions were audio-recorded, transcribed verbatim and qualitative data were analyzed by systematic text con- densation thematic analysis. RESULTS/ANTICIPATED RESULTS: Nine individuals participated (N = 4 and N = 5) in each of the two focus groups. Their mean age was 47.9 years (SD 12.1), 67% were women, and all had at least an education level of some college. Six overarching themes emerged from the data: (1) overall impression, (2) content usefulness (3) formatting, (4) implementation, (5) impact and (6) suggestions for improvement. Underpinning the themes was a high level of agreement that the intervention facilitated healthy behavioral change through cultural tailoring, multimedia education modules and social networking. Among the suggestions for improve- ment were streamlining of app self-monitoring features, personaliza- tion based on individual’s cardiovascular risk and attentiveness to nuanced cultural perspectives. DISCUSSION/SIGNIFICANCE OF IMPACT: This formative evaluation found the FAITH! App mHealth lifestyle intervention had high reported satisfaction and impact on the health-promoting behaviors of African-Americans, thereby improving their overall cardiovascular health. The findings provide further support for the acceptability of mHealth interven- tions among African-Americans. CONFLICT OF INTEREST DESCRIPTION: None. 4382 All IN for Health: Promoting good health and engaging a health research volunteer community in the Hoosier state Jessica Hall1, Christine Drury, and Carmel Egan 1Indiana University School of Medicine OBJECTIVES/GOALS: • To improve and expand health and research literacy throughout Indianabysharinghealth-focusedresourcesandresearchoutcomes. • To encourage and increase health research participation throughout Indiana by promoting health research opportunities, including clinical studies. METHODS/STUDY POPULATION: • Discover and understand community concerns and barriers to good health and clinical research participation by providing a platform for individuals and communities to share their voices. • Educate Indiana residents on the importance of participating in health research. • Engage with the community to meet them where they are (online) and continue to build relationships throughout the state. • Promote healthy living for Indiana residents by sharing health education and resources from existing state health organizations and initiatives. • Develop and maintain the largest statewide database of research volunteers. RESULTS/ANTICIPATED RESULTS: • The anticipated results from this program include engagement of all populations and all communities throughout the state in con- versation and education around good health and health research, aswell as participation inhealth research acrossthe CTSI’s partner organizations. Large-scale growth is expected in both the online communityandconsentedvolunteerregistryisexpectedtoinclude and engage racially and ethnically diverse populations, as well as special health populations, such as representatives of rural com- munities,aged,rarediseasesurvivors,andtransgenderindividuals. DISCUSSION/SIGNIFICANCE OF IMPACT: • Thorough this work, the Indiana CTSI has developed a unique program, educating the public about health research and oppor- tunities to participate, while simultaneously supporting research departments with marketing promotion of their efforts, and a ready statewide volunteer community. 4230 An App a Day: Examining Clinical Evidence for Safety and Efficacy of Diabetes Mobile Health Apps Avantika Pathak, MS1, Susan Bain2, and Eunjoo Pacifici2 1USC School of Pharmacy; 2USC Department of Regulatory and Quality Sciences OBJECTIVES/GOALS: Mobile health applications are widely used by the public but vary in how they are classified and regulated. This study examines the evidence of the safety and efficacy of mobile medical applications specifically focusing on those that are used to manage dia- betes. METHODS/STUDY POPULATION: To understand the cur- rent regulatory landscape of mobile health applications (mHealth apps) for diabetes, a literature survey was conducted using the Pubmed database. Top mHealth apps were identified by searching the Apple store website using 10 key terms associated with diabetes management applications. A maximum of ten results, when available for each key term, were studied by exploring the FDA databases to understand how the products were regulated and if any were subject to recalls. These selected mHealth apps were also searched on clinicaltrials.govtoseeifthere wereongoingorcompletedclinicaltrials and if the trials were designed to include efficacy and safety outcome measures. RESULTS/ANTICIPATED RESULTS: Of the 71 mHealth apps for diabetes management that were identified, 16 were regulated. JCTS 2020 Abstract Supplement 53 https://www.cambridge.org/core/terms. https://doi.org/10.1017/cts.2020.189 Downloaded from https://www.cambridge.org/core. Carnegie Mellon University, on 06 Apr 2021 at 00:57:40, subject to the Cambridge Core terms of use, available at http://clinicaltrials.gov https://www.cambridge.org/core/terms https://doi.org/10.1017/cts.2020.189 https://www.cambridge.org/core