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

NCT ID: NCT06055036

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2027-03-31

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; Obesity; Cardiovascular Diseases; Smoking; Sleep; Hyperlipidemias; Diet, Healthy; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Black Impact Intervention

Black Impact Intervention

Group Type: EXPERIMENTAL

Black Impact Intervention

Intervention Type: BEHAVIORAL

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.

Black Impact Waitlist Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

• healthcare provider-imposed limitations on physical activity.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Joseph, MD

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sean Matambo

Role: CONTACT

Sean.Matambo@osumc.edu

773-683-9241

Luiza Reopell

Role: CONTACT

Luiza.Reopell@osumc.edu

614-653-8213

Facility Contacts

Sean Matambo

Role: primary

Sean.Matambo@osumc.edu

773-683-9241

Luiza Reopell

Role: backup

Luiza.Reopell@osumc.edu

614-653-8213

References

Joseph JJ, Gray DM 2nd, Williams A, Zhao S, McKoy A, Odei JB, Brock G, Lavender D, Walker DM, Nawaz S, Baker C, Hoseus J, Price T, Gregory J, Nolan TS. Addressing non-medical health-related social needs through a community-based lifestyle intervention during the COVID-19 pandemic: The Black Impact program. PLoS One. 2023 Mar 9;18(3):e0282103. doi: 10.1371/journal.pone.0282103. eCollection 2023.

Reference Type: BACKGROUND

PMID: 36893165 (View on PubMed)

Addison S, Yang Y, Metlock F, King M, McKoy A, Williams A, Gregory J, Gray DM 2nd, Joseph JJ, Nolan TS. The Role of Social Support in Cardiovascular Clinical Trial Participation among Black Men: Black Impact. Int J Environ Res Public Health. 2022 Sep 23;19(19):12041. doi: 10.3390/ijerph191912041.

Reference Type: BACKGROUND

PMID: 36231354 (View on PubMed)

Joseph JJ, Nolan TS, Williams A, McKoy A, Zhao S, Aboagye-Mensah E, Kluwe B, Odei JB, Brock G, Lavender D, Gregory J, Gray DM 2nd. Improving cardiovascular health in black men through a 24-week community-based team lifestyle change intervention: The black impact pilot study. Am J Prev Cardiol. 2022 Jan 13;9:100315. doi: 10.1016/j.ajpc.2022.100315. eCollection 2022 Mar.

Reference Type: BACKGROUND

PMID: 35146467 (View on PubMed)

Nolan TS, Williams A, Gillespie SL, Gur T, Walker D, Garner JA, Galley J, Reopell L, Wilson A, Lartey K, Ojembe N, Hubbard A, Ballas J, Appana B, Aboagye-Mensah E, Smith S BS, Griffin M BS, Zhao S, Brock GN, Baker C, Hoseus J, Briggs D, Gregory J, Roberts MW, Porter M, Joseph JJ. Design of Black Impact: A Randomized Controlled Trial Evaluating the Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention. J Am Heart Assoc. 2025 Oct 7;14(19):e039380. doi: 10.1161/JAHA.124.039380. Epub 2025 Sep 25.

Reference Type: DERIVED

PMID: 40996070 (View on PubMed)

Other Identifiers

2023H0180

Identifier Type: -

Identifier Source: org_study_id