Reducing cardiovascular risk in adults facing food insecurity with financial incentives
Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives (CVD-FIT)
This study is testing whether giving financial help and support for buying healthy foods can lower heart disease risk and improve the lives of African American adults who are struggling with food insecurity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06818669 on ClinicalTrials.gov |
What this trial studies
This intervention aims to evaluate the effectiveness and cost-efficiency of CVD-FIT, which combines monthly income supplementation, weekly incentives for purchasing healthy foods, and telephone-based education on cardiovascular disease (CVD) risk reduction. The study will involve 200 African American adults who are food insecure and at risk for CVD, randomized to receive either the CVD-FIT intervention or enhanced usual care. Participants will be monitored over 12 months to assess changes in their CVD risk and quality of life.
Who should consider this trial
Good fit: Ideal candidates are African American adults aged 40 and older who are food insecure and at risk for cardiovascular diseases.
Not a fit: Patients with significant mental health issues or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower cardiovascular disease risk among food-insecure individuals.
How similar studies have performed: While similar approaches have been explored, this specific intervention combining financial incentives and education is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Buffalo, New York
- University at Buffalo — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Rebekah J Walker, PhD
- Email: rbwalker@buffalo.edu
- Phone: 716-829-5741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.