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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

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

Exclusion Criteria:

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

About the study

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

What is being tested

• Health Impact 360 (behavioral)
• Usual care - Wait list control (other)

Sponsor: University of Michigan · Participants: 328 · Started: Jun 20, 2025

Contact the study team

• Michelle Clayson · Phone: 734-763-2003

Official record on ClinicalTrials.gov — NCT07034352

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.