NCT06055036 Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
| NCT ID | NCT06055036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Cardiometabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2023-08-24 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
Eligibility Criteria
Inclusion Criteria: * The inclusion criteria are: 1) Black men (self-report); 2) adult age 18 years or older; 3) Life's Essential 8 total average score \< 80; 4) English speaking; and 5) lives in Metropolitan Columbus, Ohio. Exclusion Criteria: * healthcare provider-imposed limitations on physical activity.
Contact & Investigator
Joshua Joseph, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06055036 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Cardiometabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06055036 currently recruiting?
Yes, NCT06055036 is actively recruiting participants. Contact the research team at Sean.Matambo@osumc.edu for enrollment information.
Where is the NCT06055036 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06055036 clinical trial?
NCT06055036 is sponsored by Ohio State University. The principal investigator is Joshua Joseph, MD at Ohio State University. The trial plans to enroll 340 participants.