NCT06818669 · State University of New York at Buffalo
Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives
(CVD-FIT)
What this study is about
The overarching aim of this proposal is to test the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
Enhanced Usual Care
Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
Primary outcome measures
10-Year CVD Risk
Time frame: baseline, 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 - PREVENT
Time frame: baseline, 3-months, 6-months, and 12-months post randomization
CVD Risk will be measured using the PREVENT equation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Buffalo, New York
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations