Clinical Trial

FELLAShip to Better Health

Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-21; most recent amendment 2026-01-21.
Status change: Not Yet Recruiting → Recruiting 2026-01-06
Trial Details
NCT Number NCT07220213
Lead Sponsor University of Alabama at Birmingham
Collaborators: The Worship Center Christian Church
Conditions High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia, Blood Sugar; High, Obesity & Overweight, Diabetes Type 2
Enrollment 90 participants
Start Date 2026-01-01
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-22