NCT Number: NCT07034352
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Community Health and Social Service Centers (CHASS), Detroit, Michigan, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
Acronym: HI360
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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