Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings

The purpose of this clinical trial is to evaluate an evidence-based intervention, Health Impact 360, toward the promotion of cardiovascular health (CVH), including physical, mental, and social health outcomes, among adults living in marginalized communities. Study hypotheses include: * Participants in the Health Impact 360 intervention arm will have better CVH (i.e., a higher overall LE8 score) at the 16-week endpoint compared to the control. * Participants in the Health Impact 360 intervention arm will report better mental health (i.e., a lower perceived stress score) at the 16-week endpoint compared to the control. * Participants in the Health Impact 360 intervention arm will report better social support and well-being (i.e., higher emotional support and instrumental support scores and reduced social isolation) at the 16-week endpoint compared to control. * Participants with greater intervention engagement (e.g., better session attendance) will experience greater intervention impacts across all primary and secondary outcomes relative to the minimally engaged peers. Researchers will compare outcomes among intervention participants to outcomes among delayed intervention control participants who will be invited to participate in Health Impact 360 once all endpoint measures are collected. Participants will: * Engage in group-based programming twice per week for 8 weeks * Engage in group-based programming once per week for 8 weeks * Participate in survey-based and biometric data collection at two timepoints: baseline and 16-week endpoint * Self-monitor their physical activity via a study-provided pedometer

NCT Number	NCT07034352
Lead Sponsor	University of Michigan Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Detroit Hispanic Development Corporation, Eastside Community Network, Community Health and Social Service Center (CHASS), Community Based Organization Partners, Michigan United, Hurley Medical Center
Conditions	Health Promotion, Cardiovascular Health
Enrollment	328 participants
Start Date	2025-06-20
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-16