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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Detroit Hispanic Development Corporation | UNKNOWN |
| Eastside Community Network | UNKNOWN |
| Community Health and Social Service Center (CHASS) |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Impact 360 | Experimental | 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. |
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| Usual care - Wait list control | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Impact 360 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8) | 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. | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mental health based on the perceived stress scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Garner, PhD, RD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health and Social Service Centers (CHASS) | Detroit | Michigan | 48209 | United States | ||
| Eastside Community Network (ECN) |
The data will be made available as soon as the primary team has completed the analysis as proposed in the grant, and no later than time of an associated publication or end of the grant award, whichever comes first. Data deposited in Deep Blue Data will be accessible for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.
Data deposited in Deep Blue Data will be accessible for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.
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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.
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Statisticians will be blinded to arm assignment during analysis.
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| Usual care - Wait list control | Other | Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks. |
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| Baseline, 16 weeks |
| Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale | 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. | Baseline, 16 weeks |
| Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale | 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. | Baseline, 16 weeks |
| Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale | 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. | Baseline, 16 weeks |
| Detroit |
| Michigan |
| 48215 |
| United States |
| Detroit Hispanic Development Corporation (DHDC) | Detroit | Michigan | 48216 | United States |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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