High Blood GlucoseNCT07220213
FELLAShip to Better Health
A study testing FELLAship in people with High Blood Glucose and High Cholesterol, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia
- What is being tested?
- FELLAship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Worship Center Cristian Church
Birmingham, Alabama, 35210
Jeff Givhan, 205-451-1750 ext. 4942, jgivhan@theworshipcentercc.org
About this study
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.
Read more
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.
- Conditions
- High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia, Blood Sugar; High, Obesity & Overweight, Diabetes Type 2
- Being tested
- FELLAship
- Medical subject headings
- Hyperglycemia, Hypercholesterolemia, Hyperlipidemias, Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FELLAshipBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Weeks
Change From Baseline in Perceived Stress Score
Change from baseline in perceived stress, measured using the Perceived Stress Scale (PSS) score.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 156 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood GlucoseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized trial with intervention and control waitlist arms
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Worship Center Christian Church
- Responsible party
- Principal investigator, Nashira Brown, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220213
- Sponsor's protocol ID
- IRB-300015137
- Other IDs
- UAB
- Status last verified
- Jan 2026
- First submitted
- 21 Oct 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.