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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Grant/Funding Number | UAB Center for Clinical and Translational Science and O'Neal Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| The Worship Center Christian Church | UNKNOWN |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FELLAship | Experimental | 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. |
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| Waitlist Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FELLAship | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Life's Essential 8 Overall Score | 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. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Life's Essential 8 Blood Pressure Score | 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. | 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LeAndrea D Anderson | Contact | 2059960089 | leandreaanderson@uabmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Worship Center Cristian Church | Recruiting | Birmingham | Alabama | 35210 | United States |
Individual participant data (IPD) will not be shared because the study involves a relatively small, community-based sample recruited from a single faith-based organization. Even with de-identification, there is a heightened risk that individuals could be re-identified based on demographic characteristics or other contextual details. To protect participant privacy and honor community trust, we will limit data access to the study team and approved partners under strict data security protocols.
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050171 | Dyslipidemias |
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randomized trial with intervention and control waitlist arms
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| Change From Baseline in Life's Essential 8 Body Mass Index Score |
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. |
| 24 Weeks |
| Change in Life's Essential 8 Diet (subjective) | 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. | 24 Weeks |
| Change From Baseline in Life's Essential 8 Blood Lipids Score | 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. | 24 |
| Change From Baseline in Life's Essential 8 Blood Glucose Score | 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. | 24 Weeks |
| Change From Baseline in Perceived Stress Score | Change from baseline in perceived stress, measured using the Perceived Stress Scale (PSS) score. | 24 Weeks |
| Change in Life's Essential 8 Physical Activity (Self Reported) | 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. | 24 Weeks |
| Change in Life's Essential 8 Physical Activity (Accelerometry) | 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. | 24 Weeks |
| Change From Baseline in Life's Essential 8 Nicotine Exposure Score | 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. | 24 Weeks |
| Change From Baseline in Life's Essential 8 Sleep Health Score | 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. | 24 Weeks |
| Change From Baseline in Patient Activation Measure (PAM) Score | Change from baseline in patient activation, measured using the Patient Activation Measure (PAM) score. | 24 Weeks |
| Change From Baseline in Health-Related Social Needs Score | 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. | 24 weeks |
| RE-AIM Adoption, Implementation, and Maintenance Indicators | 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. | 156 Weeks |
| D052439 | Lipid Metabolism Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |