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

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

ArmDescriptionAssigned 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.
  • 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.

Recruiting Locations

Hasselbringe Senior Center
Flint, Michigan 48504
Contact:
Tarnesa Martin
313-583-7088
healthimpact360@umich.edu

Spirit of Victory
Flint, Michigan 48504
Contact:
Tarnesa Martin
313-583-7088
healthimpact360@umich.edu

Flint Development Center
Flint, Michigan 48505
Contact:
Latressa Gordon
313-583-7088
healthimpact360@umich.edu

RL Jones Community Center
Flint, Michigan 48505
Contact:
Latressa Gordon
313-583-7088
healthimpact360@umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Michelle Clayson
734-763-2003
mclayson@umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.