Blood Sugar; High, Diabetes Type 2, High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia, Obesity & Overweight
Conditions
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.
Interventions
BEHAVIORALFELLAship
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.
Sponsors
University of Alabama at Birmingham
The Worship Center Christian Church
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized trial with intervention and control waitlist arms
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Life's Essential 8 Overall Score | 24 Weeks | Change from baseline in the Life's Essential 8 overall cardiovascular health score (range 0-100, higher scores indicate better cardiovascular health), assessed at 12 and 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health-Related Social Needs Score | 24 weeks | Change from baseline in health-related social needs, measured using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening Tool. |
| RE-AIM Adoption, Implementation, and Maintenance Indicators | 156 Weeks | Adoption, implementation, and maintenance indicators of the FELLAship intervention, assessed using structured interviews, meeting documentation, and organizational records in alignment with the RE-AIM framework. |
| Change From Baseline in Life's Essential 8 Blood Pressure Score | 24 Weeks | Change from baseline in the Life's Essential 8 blood pressure subscore (range 0-100, higher scores indicate better cardiovascular health), derived from systolic and diastolic blood pressure measured using an automated sphygmomanometer. |
| Change From Baseline in Life's Essential 8 Body Mass Index Score | 24 Weeks | Change from baseline in the Life's Essential 8 body mass index subscore (range 0-100, higher scores indicate better cardiovascular health), calculated using measured height (inches) and weight (pounds) to derive BMI. |
| Change in Life's Essential 8 Diet (subjective) | 24 Weeks | Change from baseline in the Life's Essential 8 diet subscore (range 0-100, higher scores indicate better cardiovascular health), measured using the 16-item Mediterranean Eating Pattern for Americans questionnaire. |
| Change From Baseline in Life's Essential 8 Blood Lipids Score | 24 | Change from baseline in the Life's Essential 8 blood lipids subscore (range 0-100, higher scores indicate better cardiovascular health), derived from non-HDL cholesterol measured from a blood sample. |
| Change From Baseline in Life's Essential 8 Blood Glucose Score | 24 Weeks | Change from baseline in the Life's Essential 8 blood glucose subscore (range 0-100, higher scores indicate better cardiovascular health), derived from hemoglobin A1c measured from a blood sample. |
| Change From Baseline in Perceived Stress Score | 24 Weeks | Change from baseline in perceived stress, measured using the Perceived Stress Scale (PSS) score. |
| Change in Life's Essential 8 Physical Activity (Self Reported) | 24 Weeks | Change from baseline in the Life's Essential 8 physical activity subscore (range 0-100, higher scores indicate better cardiovascular health), derived from self-reported minutes of moderate or vigorous physical activity per week. |
| Change in Life's Essential 8 Physical Activity (Accelerometry) | 24 Weeks | Change from baseline in the Life's Essential 8 physical activity subscore (range 0-100, higher scores indicate better cardiovascular health), derived from 7 days of accelerometry data collected using an ActiGraph device. |
| Change From Baseline in Life's Essential 8 Nicotine Exposure Score | 24 Weeks | Change from baseline in the Life's Essential 8 nicotine exposure subscore (range 0-100, higher scores indicate better cardiovascular health), based on self-reported use of cigarettes or inhaled nicotine delivery systems. |
| Change From Baseline in Patient Activation Measure (PAM) Score | 24 Weeks | Change from baseline in patient activation, measured using the Patient Activation Measure (PAM) score. |
| Change From Baseline in Life's Essential 8 Sleep Health Score | 24 Weeks | Change from baseline in the Life's Essential 8 sleep health subscore (range 0-100, higher scores indicate better cardiovascular health), measured using self-reported average hours of sleep per night. |
Countries
United States
Contacts
CONTACTLeAndrea D Anderson
Outcome results
None listed