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

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.