FELLAShip to Better Health

N/ARecruitingNCT07220213

University of Alabama at Birmingham90 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Interventions

FELLAshipBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 24 Weeks

Secondary Outcomes

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.

Time frame: 24 Weeks

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 Weeks

Change From Baseline in Perceived Stress Score

Change from baseline in perceived stress, measured using the Perceived Stress Scale (PSS) score.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 156 Weeks

FELLAShip to Better Health

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts