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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD018721-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The overarching aim of this proposal is to test the efficacy and cost-effectiveness of CVD-FIT, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training in African Americans with food insecurity.
Study Overview: 200 African American adults at risk for CVD with food insecurity will be randomized 1:1 to CVD-FIT or enhanced usual care (CVD risk reduction education). Each patient will be followed for 12 months, with study visits at baseline, 3, 6, and 12 months. The primary outcome will be 10-year CVD risk using the Pooled Cohort Equation at 12 months post-randomization while the secondary outcomes will be quality of life at 12 months post-randomization and cost-effectiveness of the CVD-FIT intervention compared to enhanced usual care.
Patient Randomization. A permuted block randomization method will be used to assign subjects to intervention or control. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines.
Description of the CVD-FIT Intervention: The CVD-FIT intervention will incorporate 1) $100 monthly income supplementation; 2) $50 weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training.
Enhanced Usual Care Control Group: Participants randomized to the enhanced usual care group will receive the same mailed education and health educator delivered education and skills training sessions as the CVD-FIT intervention group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVD-FIT | Experimental | The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator. |
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| Enhanced Usual Care | Active Comparator | Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVD-FIT | Behavioral | The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-Year CVD Risk | 10-year CVD risk will be measured by the Pooled Cohort risk reduction equation recommended for race- and sex- specific risk calculation for African Americans 40 to 79 years of age. | baseline, 3-months, 6-months, and 12-months post randomization |
| CVD Risk - PREVENT | CVD Risk will be measured using the PREVENT equation | baseline, 3-months, 6-months, and 12-months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Physical and Mental Health Related Quality of Life | Quality of Life will be measured using the SF-12 questionnaire and reported as physical health related and mental health related scores (score ranges from 0 to 100 with higher numbers indicating better quality of life) | baseline, 3-months, 6-months, and 12-months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebekah J Walker, PhD | Contact | 716-829-5741 | rbwalker@buffalo.edu | |
| Jocelyn Stooks, MPH | Contact | 716-829-2364 | jstooks@buffalo.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| University at Buffalo | Recruiting | Buffalo | New York | 14203 | United States |
individual participant data will not be shared to protect privacy of participants
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| ID | Term |
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| D002318 | Cardiovascular Diseases |
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Patients will be randomized 1:1 to CVD-FIT (a multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training) or enhanced usual care (CVD risk reduction education).
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| Enhanced Usual Care | Behavioral | Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator. |
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