Recruiting

Health Impact 360

Sponsor:

University of Michigan

Code:

NCT07034352

Conditions

Health Promotion

Cardiovascular Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Health Impact 360

Usual care - Wait list control

Study Details

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

Conditions

Health Promotion

Cardiovascular Health

Study ID

NCT07034352

Start date

Jun 20, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

328 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8) [ Time Frame: Baseline, 16 weeks ]

Central Contacts and Locations

Central contacts

Locations

Hasselbringe Senior Center

Recruiting

Flint, Michigan, United States, 48504

Contacts

Spirit of Victory

Recruiting

Flint, Michigan, United States, 48504

Contacts

Flint Development Center

Recruiting

Flint, Michigan, United States, 48505

Contacts

RL Jones Community Center

Recruiting

Flint, Michigan, United States, 48505

Contacts

More Information

Sponsor

University of Michigan

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Health Program
  • Health outcomes
  • Social health
  • Walking
  • Health Education and support
  • Mental health
  • social support
  • Health disparities
  • self management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-16.