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

NCT06055036 | Recruiting

• 1 other identifier: 2023H0180
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Health

  The primary outcome for the randomized controlled trial is change in cardiovascular health at 24-week follow-up, which will be calculated using between-subject differences rather than within-subject differences, using a linear mixed-effects to evaluate changes from baseline in Life's Essential 8 score (range 0-100, higher scores are better). Study wave will be a covariate in the models. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24-weeks). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. Residual plots will examine model assumptions and model fit, with transformation of the outcomes (e.g. log, square-root, Box-Cox) used as needed to satisfy modelling assumptions (e.g. normality, constant variance) and achieve appropriate model fit.

  24 weeks

Secondary Outcomes (21)

• Change in Perceived Stress

  24 weeks

• Change in Life's Essential 8 Blood Pressure

  24 weeks

• Change in Life's Essential 8 Blood Lipids

  24 weeks

• Change in Life's Essential 8 Blood Glucose

  24 weeks

• Change in Life's Essential 8 Body Mass Index

  24 weeks

Study Arms (2)

Black Impact Intervention

EXPERIMENTAL

Black Impact Intervention

Behavioral: Black Impact Intervention

Black Impact Waitlist Control

NO INTERVENTION

Usual Care

Interventions

Black Impact Intervention 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 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• healthcare provider-imposed limitations on physical activity.

Sponsors & Collaborators

• Ohio State University: lead
• American Heart Association: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43202, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 36893165 BACKGROUND

• 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.

  PMID: 36231354 BACKGROUND

• 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.

  PMID: 35146467 BACKGROUND

• 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.

  PMID: 40996070 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Sedentary Behavior; Hypertension; Diabetes Mellitus, Type 2; Prediabetic State; Obesity; Cardiovascular Diseases; Smoking; Hyperlipidemias

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Vascular Diseases; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Joshua Joseph, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Matambo

CONTACT

773-683-9241; Sean.Matambo@osumc.edu

Luiza Reopell

CONTACT

614-653-8213; Luiza.Reopell@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyst is blinded to the intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: randomized, wait-list controlled trial with 2 arms

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 26, 2023
• Study Start: August 24, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)