Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives
NCT ID: NCT06818669
Last Updated: 2026-02-06
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-06-01
2031-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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CVD-FIT
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.
CVD-FIT
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.
Enhanced Usual Care
Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
Enhanced Usual Care
Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
Interventions
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CVD-FIT
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.
Enhanced Usual Care
Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
Eligibility Criteria
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Inclusion Criteria
* screen positive for food insecurity over the past 12-months using a food insecurity risk tool developed through completion of the research team's current NIH funded R01 (R01MD013826)
* at risk for CVD defined as age ≥40 years and having a clinical diagnosis of diabetes, or hypertension, or hyperlipidemia, or being overweight/obese (defined as a BMI\>25), or being a current smoker
* able to communicate in English.
Exclusion Criteria
* Participation in other cardiovascular disease clinical trials
* Alcohol or drug abuse/dependency based on screening using CAGE questionnaire
* Active psychosis or acute mental disorder based on self-report
* Life expectancy \<12 months.
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
State University of New York at Buffalo
OTHER
Responsible Party
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Rebekah Jo Walker
Principal Investigator
Locations
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University at Buffalo
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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