FELLAShip to Better Health

NCT ID: NCT07220213

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FELLAship

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.

Group Type: EXPERIMENTAL

FELLAship

Intervention Type: BEHAVIORAL

TheFELLAship intervention, grounded in Social Cognitive Theory (SCT) and guided by the Socioecological Model (SEM), focuses on enhancing participants' skills, knowledge and beliefs, and self-efficacy to promote cardiovascular health (CVH). The program provides health education aligned with the Diabetes Prevention Program (DPP) and American Heart Association's Check. Change. Control. (AHA CCC) curriculum to support behavior change in diet, physical activity, tobacco use, sleep, and clinical care engagement. Team-based coaching and physical activity sessions strengthen behavioral confidence and skill application.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FELLAship

TheFELLAship intervention, grounded in Social Cognitive Theory (SCT) and guided by the Socioecological Model (SEM), focuses on enhancing participants' skills, knowledge and beliefs, and self-efficacy to promote cardiovascular health (CVH). The program provides health education aligned with the Diabetes Prevention Program (DPP) and American Heart Association's Check. Change. Control. (AHA CCC) curriculum to support behavior change in diet, physical activity, tobacco use, sleep, and clinical care engagement. Team-based coaching and physical activity sessions strengthen behavioral confidence and skill application.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Worship Center Christian Church

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Nashira Brown

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Worship Center Cristian Church

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

LeAndrea D Anderson

Role: CONTACT

leandreaanderson@uabmc.edu

2059960089

Facility Contacts

Jeff Givhan

Role: primary

jgivhan@theworshipcentercc.org

205-451-1750 ext. 4942

Other Identifiers

UAB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300015137

Identifier Type: -

Identifier Source: org_study_id