Recruiting

FELLAShip to Better Health

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…

ClinicalTrials.gov IDNCT07220213
PhaseNA
Enrollment90
SponsorUniversity of Alabama at Birmingham
Age18 Years
SexMALE
I'm interested View official listing

Conditions studied

High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia, Blood Sugar; High, Obesity & Overweight, Diabetes Type 2

About this study

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.

Interventions

Primary outcomes

Eligibility information

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)

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.