RecruitingNot ApplicableNCT07220213

FELLAShip to Better Health


Sponsor

University of Alabama at Birmingham

Enrollment

90 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called FELLAShip to Better Health — is a community-based program designed to help Black men in the Birmingham, Alabama area improve their heart health through peer support and lifestyle changes. The program addresses the reality that Black men face disproportionately high rates of heart disease. **You may be eligible if...** - You identify as a Black man - You are 18 or older - You live in the greater Birmingham, Alabama metro area - You speak English - Your overall cardiovascular health score (Life's Essential 8) is below ideal - You have no restrictions from a doctor about physical activity **You may NOT be eligible if...** - You do not identify as a Black man - You are under 18 - You live outside the Birmingham, AL metro area - You do not speak English - Your doctor has told you not to exercise - Your cardiovascular health is already considered ideal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFELLAship

TheFELLAship 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.


Locations(1)

The Worship Center Cristian Church

Birmingham, Alabama, United States

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NCT07220213


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