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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
The Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Sean Matambo
Sean.Matambo@osumc.edu
773-683-9241
Backup
Luiza Reopell
Luiza.Reopell@osumc.edu
614-653-8213
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 340
Treatments
Experimental: Black Impact Intervention
Black Impact Intervention
No_intervention: Black Impact Waitlist Control
Usual Care
Sponsors
Collaborators: American Heart Association
Leads: Ohio State University

This content was sourced from clinicaltrials.gov