findmyKOL
Clinical trialNCT06055036RecruitingInterventional

Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention

SponsorOhio State UniversityEnrollment340Blood PressureCardiometabolic SyndromeCardiovascular DiseasesDiet, HealthyHyperlipidemiasHypertension+6 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • the Ohio State University

    Columbus, Ohio, United States

    Joshua Joseph
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
24 Aug 2023
Primary completion
31 Mar 2026
Completion
31 Mar 2027
Last update posted
6 Oct 2025
Registered enrollment
340
Registry id
NCT06055036

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.