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

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

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Detroit Hispanic Development Corporation

  collaborator UNKNOWN

• Eastside Community Network

  collaborator UNKNOWN

• Community Health and Social Service Center (CHASS)

  collaborator UNKNOWN

• University of Michigan

  lead OTHER

Principal Investigators

• Jennifer Garner, PhD, RD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-20

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• United States

Study Locations