NCT07034352

Health Impact 360: Advancing Physical, Social, and Mental Health Among Marginalized Communities for Cardiovascular Health Equity

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Health Promotion
• Cardiovascular Health

Interventions

Type	Name	Description
BEHAVIORAL	Health Impact 360	Participants will be assigned to a team and teams will meet 1-2 times per week for sessions at a local community organization. Sessions will be up to 2 hours long and will include two parts: (1) 30-60 minutes of activities related to physical, mental, social, financial, and community health, and (2) 60-75 minutes of group physical activity (walking), including stretches to warm up and cool down.
OTHER	Usual care - Wait list control	Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-06-24
• Last updated: 2026-01-20

Locations

3 sites across 1 country: United States