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NCT07220213Recruiting

FELLAShip to Better Health

Source: ClinicalTrials.gov · Last updated 22 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
21 Oct 2025
Start date
1 Jan 2026
Primary completion date
1 Jan 2027
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT07220213

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 1 Jan 2026 to the primary completion date, 1 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Under age 18

Other

  • Not identifying as Black and male
  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Worship Center Cristian Church
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.