Health Impact 360: Advancing Physical, Social, and Mental Health Among Marginalized Communities for Cardiovascular Health Equity
NCT ID: NCT07034352
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
328 participants
INTERVENTIONAL
2025-06-20
2026-11-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Able to participate in group-based programming
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Detroit Hispanic Development Corporation
UNKNOWN
Eastside Community Network
UNKNOWN
Community Health and Social Service Center (CHASS)
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Jennifer Garner
Assistant Professor
Principal Investigators
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Jennifer Garner, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Community Health and Social Service Centers (CHASS)
Detroit, Michigan, United States
Eastside Community Network (ECN)
Detroit, Michigan, United States
Detroit Hispanic Development Corporation (DHDC)
Detroit, Michigan, United States
Countries
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Other Identifiers
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HUM00256551
Identifier Type: -
Identifier Source: org_study_id
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