Health Impact 360: Advancing Physical, Social, and Mental Health Among Marginalized Communities for Cardiovascular Health Equity (HI360)

January 16, 2026 updated by: Jennifer Garner, University of Michigan

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48216
        • Detroit Hispanic Development Corporation (DHDC)
      • Detroit, Michigan, United States, 48209
        • Community Health and Social Service Centers (CHASS)
      • Detroit, Michigan, United States, 48215
        • Eastside Community Network (ECN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Impact 360
16-week, group-based comprehensive health program that covers all behavioral and clinical dimensions of heart health: healthy eating, physical activity, quality sleep, tobacco cessation, blood pressure, cholesterol, Hemoglobin A1c, and Body Mass Index.
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 that will be on the wait list will be evaluated. These participants will be enrolled into the treatment program 16-20 weeks after the first treatment group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)
Time Frame: 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.
Baseline, 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mental health based on the perceived stress scale
Time Frame: 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.
Baseline, 16 weeks
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale
Time Frame: 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.
Baseline, 16 weeks
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale
Time Frame: 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.
Baseline, 16 weeks
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale
Time Frame: 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.
Baseline, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Detroit Hispanic Development Corporation
Eastside Community Network
Community Health and Social Service Center (CHASS)

Investigators

  • Principal Investigator: Jennifer Garner, PhD, RD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 13, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Actual)

June 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00256551
  • OT2HL158287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be made available as soon as the primary team has completed the analysis as proposed in the grant, and no later than time of an associated publication or end of the grant award, whichever comes first. Data deposited in Deep Blue Data will be accessible for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.

IPD Sharing Time Frame

Data deposited in Deep Blue Data will be accessible for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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