Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives

This study is looking at ways to lower the risk of heart and blood vessel diseases (cardiovascular diseases or CVD) in African American adults who have trouble getting enough food (food insecurity). It's testing an intervention called CVD-FIT, which includes monthly income support, weekly money for healthy food, and education on reducing CVD risk. This is compared to an "Enhanced Usual Care" group that only receives the education. The study wants to see if CVD-FIT can reduce your 10-year risk of CVD and improve your quality of life. To join, you must be an African American adult, at least 18 years old, have experienced food insecurity in the past year, and be at risk for CVD (for example, if you are 40 or older and have diabetes, high blood pressure, or high cholesterol). The study is currently unclear about its recruitment status.

Study design
This is an interventional study planning to enroll 200 participants. Participants will be randomly assigned to either the CVD-FIT group or the Enhanced Usual Care group.
What's involved
You would have study visits at the beginning, 3 months, 6 months, and 12 months after being assigned to a group. The CVD-FIT group would receive monthly income supplementation and weekly reimbursement for healthy food purchases, along with mailed education and telephone calls with a health educator. The Enhanced Usual Care group would receive mailed education and telephone calls with a health educator.
Compensation
The CVD-FIT intervention includes $100 monthly income supplementation and a $50 weekly structured incentive for the purchase of healthy food options.
Follow-up
Participants will be followed for 12 months after being assigned to a group.

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NCT06818669

Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives

Recruiting
NAAges 18+InterventionalHealth services
State University of New York at Buffalo
~200 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:CVD-FITEnhanced Usual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
10-Year CVD Risk
Measured over baseline, 3-months, 6-months, and 12-months post randomization
+1 more outcome measured
Cardiovascular Diseases
1 sites across 1 states
New York1

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Eligibility criteria

Inclusion

self-report as African American/non-Hispanic Black
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

Mental confusion on interview suggesting significant dementia
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.
  • 10-Year CVD Riskbaseline, 3-months, 6-months, and 12-months post randomization

    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.

  • CVD Risk - PREVENTbaseline, 3-months, 6-months, and 12-months post randomization

    CVD Risk will be measured using the PREVENT equation