Recruiting

FELLAship Program

Sponsor:

University of Alabama at Birmingham

Code:

NCT07220213

Conditions

High Blood Glucose

High Cholesterol

High Cholesterol/Hyperlipidemia

Blood Sugar; High

Obesity & Overweight

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FELLAship

Study Details

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

Study ID

NCT07220213

Start date

Jan 1, 2026

Status verified date

Jan, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Change From Baseline in Life's Essential 8 Overall Score [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

LeAndrea D Anderson

2059960089leandreaanderson@uabmc.edu

Locations

The Worship Center Cristian Church

Recruiting

Birmingham, Alabama, United States, 35210

Contacts

Jeff Givhan

205-451-1750jgivhan@theworshipcentercc.org

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-01-22.