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

Not Applicable

Recruiting

• Conditions: Health Promotion; Cardiovascular Health

• Registration Number: NCT07034352
• Lead Sponsor: University of Michigan

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study Start: 2025-06-20
• Study First Submitted QC: 2025-06-23
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)	Baseline, 16 weeks	LE8 CVH Score will be averaged for each participant at baseline and 16 weeks on the individual LE8 metrics (i.e., scores of 0-100 for eight items). An average score of 0 to 49 is defined as low CVH, 50 to 79 is moderate CVH, and 80 to 100 is high CVH.

Secondary Outcome Measures

Name	Time	Method
Change in mental health based on the perceived stress scale	Baseline, 16 weeks	The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale	Baseline, 16 weeks	This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating more emotional support.
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale	Baseline, 16 weeks	This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating more instrumental support.
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale	Baseline, 16 weeks	This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating greater social isolation.

Trial Locations

Locations (3)

Community Health and Social Service Centers (CHASS); 🇺🇸 Detroit, Michigan, United States

Eastside Community Network (ECN); 🇺🇸 Detroit, Michigan, United States

Detroit Hispanic Development Corporation (DHDC); 🇺🇸 Detroit, Michigan, United States