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

Overview

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.

Interventions

• Behavioral 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 participan

Primary outcome measures

• Cardiovascular Health [Time frame: 24 weeks]

Secondary outcome measures (12)

• Change in Perceived Stress [Time frame: 24 weeks]
• Change in Life's Essential 8 Blood Pressure [Time frame: 24 weeks]
• Change in Life's Essential 8 Blood Lipids [Time frame: 24 weeks]
• Change in Life's Essential 8 Blood Glucose [Time frame: 24 weeks]
• Change in Life's Essential 8 Body Mass Index [Time frame: 24 weeks]
• Change in Life's Essential 8 Diet (subjective) [Time frame: 24 weeks]
• Change in Life's Essential 8 Diet (objective) [Time frame: 24 weeks]
• Change in Life's Essential 8 Physical Activity (subjective) [Time frame: 24 weeks]
• Change in Life's Essential 8 Physical Activity (objective) [Time frame: 24 weeks]
• Change in Life's Essential 8 Nicotine Exposure [Time frame: 24 weeks]
• Change in Life's Essential 8 Sleep Health [Time frame: 24 weeks]
• Change in Central Aortic Pressure [Time frame: 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• The Ohio State University — Columbus

Publications

• 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
• 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
• 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
• 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 Reductio PMID 40996070

Identifiers

NCT: NCT06055036 · 2023H0180

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗