FELLAShip to Better Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Not identifying as Black and male

Under age 18

Non-English speakers

Not living in the Birmingham, Alabama metro area

Trial design

Treatments tested in this trial

  • FELLAship

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

The Worship Center Christian Church

Collaborator