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

Recruiting now · Not applicable

Conditions studied: Health Promotion, Cardiovascular Health

In brief

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

Key facts

Study ID

NCT07034352

Run by

University of Michigan

People needed

328

Starts

2025-06-20

Expected to finish

2026-12-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• English or Spanish speaking
• Able to participate in group-based programming

You may not qualify if…

• All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses

Where it is running

• Hasselbringe Senior Center — Flint, Michigan, United States (enrolling)
• Spirit of Victory — Flint, Michigan, United States (enrolling)
• Flint Development Center — Flint, Michigan, United States (enrolling)
• RL Jones Community Center — Flint, Michigan, United States (enrolling)
• Eastside Community Network (ECN) — Detroit, Michigan, United States
• Detroit Hispanic Development Corporation (DHDC) — Detroit, Michigan, United States
• Community Health and Social Service Centers (CHASS) — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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