An interventional study of FELLAship in High Blood Glucose, High Cholesterol and High Cholesterol/Hyperlipidemia, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
Among 316 studies in Hyperglycemia with a site in United States — 30 open to participants now, 38 under way, 1 of them phase 3. Hyperglycemia · United States.
Among the 316 studies in Hyperglycemia with a site in United States, this one is the 90th largest by planned enrollment of the 265 interventional ones that give a count, is one of 9 that started in 2026, is one of 143 with no phase, reaches primary completion later than 17 of the 37 other live ones, and was the 309th registered.
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 90 is above the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →30 of the 316 studies in Hyperglycemia with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 72 Hyperglycemia studies recruiting now, 43 (60%) set no upper age limit and 23 (32%) stop at 75 or younger; 11 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →316 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 33 · Phase 2 30 · Phase 3 27 · Phase 4 43
First in 1998; this study’s year is marked. 9 started in 2026.
Median enrollment 48 across the 265 interventional studies, 84 across the 50 observational. Of the 258 that completed or were terminated, 111 (43%) have results posted.
39 of 316 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 1 study filed under Hyperglycemia — fewer than ten, so there is no comparison to draw.
20 of the studies in Hyperglycemia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07215312Eli Lilly and CompanyA Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin | 2026-11 |
| NCT07543068Sam Houston State UniversityDiabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults | 2026-11 |
| NCT07216508Icahn School of Medicine at Mount SinaiLiver Transplant CGM | 2026-11-30 |
| NCT05455619SynDevRx, Inc.Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer | 2026-12 |
| NCT07270016University of PittsburghPilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes | 2026-12 |
Among the 316 studies in Hyperglycemia with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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
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
Plan to share: 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 208 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 12 months is below that.
Counting every sponsor, half of 225 studies reached it within 14 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Alabama at Birmingham →