FELLAShip to Better Health
Recruiting · NCT07220213 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Resides in the Metropolitan Birmingham, Alabama area
- No physical activity restrictions imposed by a healthcare provider
Exclusion criteria
- Not identifying as Black and male
- Under age 18
- Non-English speakers
- Not living in the Birmingham, Alabama metro area
- Having a healthcare provider-imposed restriction on physical activity
- Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)
Where it is running
3 locations listed across 1 US state.
- The Worship Center Cristian Church - Birmingham, Alabama, United States
- The Worship Center Cristian Church - Birmingham, Alabama, United States
- The Worship Center Cristian Church - Birmingham, Alabama, United States