The goal of this clinical trial is to evaluate the implementation and effectiveness of the FELLAship program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are:
* Does participation in the FELLAship program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)? * What factors influence the adoption, delivery, and sustainability of the FELLAship program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors.
Participants will:
* Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches. * Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care. * Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes. * Use a smartwatch, blood pressure cuff, and other tools to track progress in real time. * Participate in exit focus groups or interviews to share feedback about the intervention. * A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability.
This study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.
Self-identified Black men
Age 18 or older
LE8 (Life's Essential 8) score (threshold not specified, but implies "less than ideal" CVH)
English speaking
Not identifying as Black and male
Under age 18
Non-English speakers
Not living in the Birmingham, Alabama metro area
Crossover
FELLAship
BehavioralTheFELLAship intervention, grounded in Social Cognitive Theory (SCT) and guided by the Socioecological Model (SEM), focuses on enhancing participants' skills, knowledge and beliefs, and self-efficacy to promote cardiovascular health (CVH). The program provides health education aligned with the Diabetes Prevention Program (DPP) and American Heart Association's Check. Change. Control. (AHA CCC) curriculum to support behavior change in diet, physical activity, tobacco use, sleep, and clinical care engagement. Team-based coaching and physical activity sessions strengthen behavioral confidence and skill application.
Change From Baseline in Life's Essential 8 Overall Score
Change from baseline in the Life's Essential 8 overall cardiovascular health score (range 0-100, higher scores indicate better cardiovascular health), assessed at 12 and 24 weeks.
Change From Baseline in Life's Essential 8 Blood Pressure Score
Change from baseline in the Life's Essential 8 blood pressure subscore (range 0-100, higher scores indicate better cardiovascular health), derived from systolic and diastolic blood pressure measured using an automated sphygmomanometer.
Change From Baseline in Life's Essential 8 Body Mass Index Score
Change from baseline in the Life's Essential 8 body mass index subscore (range 0-100, higher scores indicate better cardiovascular health), calculated using measured height (inches) and weight (pounds) to derive BMI.
Change in Life's Essential 8 Diet (subjective)
Change from baseline in the Life's Essential 8 diet subscore (range 0-100, higher scores indicate better cardiovascular health), measured using the 16-item Mediterranean Eating Pattern for Americans questionnaire.
Change From Baseline in Life's Essential 8 Blood Lipids Score
Change from baseline in the Life's Essential 8 blood lipids subscore (range 0-100, higher scores indicate better cardiovascular health), derived from non-HDL cholesterol measured from a blood sample.
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University of Alabama at Birmingham
Lead sponsor
The Worship Center Christian Church
Collaborator
