FELLAShip to Better Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FELLAship.
- Who it may be relevant to
- Registry conditions: High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia, Blood Sugar; High. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Change From Baseline in Life's Essential 8 Overall Score [Time frame: 24 Weeks]
Secondary outcome measures (12)
- Change From Baseline in Life's Essential 8 Blood Pressure Score [Time frame: 24 Weeks]
- Change From Baseline in Life's Essential 8 Body Mass Index Score [Time frame: 24 Weeks]
- Change in Life's Essential 8 Diet (subjective) [Time frame: 24 Weeks]
- Change From Baseline in Life's Essential 8 Blood Lipids Score [Time frame: 24]
- Change From Baseline in Life's Essential 8 Blood Glucose Score [Time frame: 24 Weeks]
- Change From Baseline in Perceived Stress Score [Time frame: 24 Weeks]
- Change in Life's Essential 8 Physical Activity (Self Reported) [Time frame: 24 Weeks]
- Change in Life's Essential 8 Physical Activity (Accelerometry) [Time frame: 24 Weeks]
- Change From Baseline in Life's Essential 8 Nicotine Exposure Score [Time frame: 24 Weeks]
- Change From Baseline in Life's Essential 8 Sleep Health Score [Time frame: 24 Weeks]
- Change From Baseline in Patient Activation Measure (PAM) Score [Time frame: 24 Weeks]
- Change From Baseline in Health-Related Social Needs Score [Time frame: 24 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The Worship Center Cristian Church — Birmingham
Identifiers
NCT: NCT07220213 · IRB-300015137 · UAB