Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a waitlist-control trial. The intervention-randomized participants will receive the intervention first in "Wave 1" and the participants randomized to the control group, "Wave 2", will experience a delay in access to the program until after the end of the Wave 1 intervention period at each participating site.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Statisticians will be blinded to arm assignment during analysis.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Flint, Michigan 48504
Flint, Michigan 48504
Flint, Michigan 48505
Flint, Michigan 48505
More Details
- Status
- Recruiting
- Sponsor
- University of Michigan