| NCT ID | NCT07220213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | High Blood Glucose |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07220213 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying High Blood Glucose. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07220213 currently recruiting?
Yes, NCT07220213 is actively recruiting participants. Contact the research team at leandreaanderson@uabmc.edu for enrollment information.
Where is the NCT07220213 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT07220213 clinical trial?
NCT07220213 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 90 participants.