Cardiovascular Health, Health Promotion
Conditions
Keywords
Health Program, Health outcomes, Social health, Walking, Health Education and support, Mental health, social support, Health disparities, self management
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
Interventions
BEHAVIORALHealth 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.
OTHERUsual 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.
Sponsors
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Detroit Hispanic Development Corporation
Eastside Community Network
Community Health and Social Service Center (CHASS)
Community Based Organization Partners
Michigan United
Hurley Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statisticians will be blinded to arm assignment during analysis.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mental health based on the perceived stress scale | 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. |
| Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale | 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. |
| Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale | 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. |
| Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale | 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. |
Countries
United States
Contacts
CONTACTMichelle Clayson
PRINCIPAL_INVESTIGATORJennifer Garner, PhD, RD
University of Michigan
Outcome results
None listed