NCT07220213

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

October 21, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

October 21, 2025

Last Update Submit

January 21, 2026

Conditions

High Blood GlucoseHigh CholesterolHigh Cholesterol/HyperlipidemiaBlood Sugar; HighObesity & OverweightDiabetes Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (13)

  • Change From Baseline in Life's Essential 8 Blood Pressure Score

    24 Weeks

  • Change From Baseline in Life's Essential 8 Body Mass Index Score

    24 Weeks

  • Change in Life's Essential 8 Diet (subjective)

    24 Weeks

  • Change From Baseline in Life's Essential 8 Blood Lipids Score

    24

  • Change From Baseline in Life's Essential 8 Blood Glucose Score

    24 Weeks

  • +8 more secondary outcomes

Study Arms (2)

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.

Behavioral: FELLAship

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.

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.

FELLAship

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Worship Center Cristian Church

Birmingham, Alabama, 35210, United States

RECRUITING

MeSH Terms

Conditions

HyperglycemiaHypercholesterolemiaHyperlipidemiasObesityOverweightDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

LeAndrea D Anderson

CONTACT

2059960089leandreaanderson@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: randomized trial with intervention and control waitlist arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2025

First Posted

October 23, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)