FELLAShip to Better Health

The University of Alabama at Birmingham

Status: Enrolling

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

Treatments: Behavioral: FELLAship

Study type: Interventional

Funder types: Other

Identifiers

NCT07220213

UAB (Other Grant/Funding Number)

IRB-300015137

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

FELLAship

Experimental group

Description:

FELLAship intervention participants will receive the 24-week intervention according to the curriculum, to be delivered by a health coach, personal trainer, and community health worker.

Treatment:

Behavioral: FELLAship

Waitlist Control

No Intervention group

Description:

Individuals in the waitlist control arm will not receive the intervention during the evaluation period. They will have access to the intervention post-evaluation period.