Recruiting

Cardiovascular Health

Sponsor:

Ohio State University

Code:

NCT06055036

Conditions

Cardiometabolic Syndrome

Physical Inactivity

Hypertension

Type 2 Diabetes

PreDiabetes

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Black Impact Intervention

Study Details

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.

Conditions

Cardiometabolic Syndrome

Physical Inactivity

Hypertension

Type 2 Diabetes

PreDiabetes

Study ID

NCT06055036

Start date

Aug 24, 2023

Status verified date

Sep, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Black Impact Intervention

Black Impact Intervention

no intervention: Black Impact Waitlist Control

Usual Care

Interventions

Black Impact Intervention

The Black Impact intervention is an academic-community-government partnership adapted from the Diabetes Prevention Program and American Heart Association Check, Change, Control programs based on stakeholder feedback and to afford incorporation of additional evidence-based strategies for influencing target outcomes. The intervention is a 24-week community-based lifestyle intervention to improve cardiovascular health among Black men. Each participant will be assigned to a group with >5 participants based on participant proximity to a central community meeting location. Each team will be guided weekly by a health coach who delivers content and coaching around the lifestyle intervention modeled on the diabetes prevention program and check, change, control blood pressure program, a community health worker who helps to address social needs and connects participants to primary care services, and a trainer who leads physical activity. Teams meet for 90 minutes per week.

Primary outcome measure

  • Cardiovascular Health [ Time Frame: 24 weeks ]

Central Contacts and Locations

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43202

Contacts

Principal Investigator:

Joshua Joseph

More Information

Sponsor

Ohio State University

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.