Design of Black Impact: A Randomized Controlled Trial Evaluating the Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention.

Abstract

Background: Lower attainment of cardiovascular health (CVH), indicated by lower scores on the American Heart Association's Life's Essential 8 metrics, is a major contributor to Black men having the shortest life expectancy of any nonindigenous race/sex group. Evidence-based community interventions to improve CVH in Black men are sparse; thus, an academic-community-government-industry partnership was developed to cocreate and test a 24-week CVH intervention for Black men, Black Impact, in line with best practices for community-based participatory research.

Methods and results: The Black Impact intervention is delivered by health coaches, fitness trainers, and community health workers and emphasizes weekly physical activity, health education, and addressing social needs. Together, academic-community-government-industry partners will conduct a randomized, waitlist-controlled trial among 340 Black men with suboptimal CVH to determine intervention: (1) efficacy on CVH and psychosocial stress; (2) effect on individual and interpersonal outcomes; (3) effect on biological mechanisms responsive to psychosocial stress; and (4) organizational contexts and resources necessary for sustainability of the academic-community-government-industry partnership. An intervention working group of academic-community-government-industry partner representatives will guide implementation and evaluation. Upon trial completion, findings (eg, change in CVH at 24 weeks [primary], change in perceived stress at 24 weeks [coprimary], biological mechanisms, psychosocial process mediators [stress, social and interpersonal processes]) will be disseminated in scientific and lay settings.

Conclusions: Robust clinical trials are needed to test novel interventions focused on CVH equity. Black Impact will determine intervention efficacy, evaluate biological and psychosocial mediators of impact, and lay a framework for sustainability and scalability.

Registration: URL: https://clinicaltrials.gov/; Unique Identifier: NCT06055036.