Recruiting

Cardiovascular Risk Reduction

Sponsor:

State University of New York at Buffalo

Code:

NCT06818669

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CVD-FIT

Enhanced Usual Care

Study Details

Brief summary:

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.

Conditions

Cardiovascular Diseases

Study ID

NCT06818669

Start date

Jun 1, 2025

Status verified date

Feb, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Enhanced Usual Care

Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.

Interventions

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.

Primary outcome measure

  • 10-Year CVD Risk [ Time Frame: baseline, 3-months, 6-months, and 12-months post randomization ]
  • CVD Risk - PREVENT [ Time Frame: baseline, 3-months, 6-months, and 12-months post randomization ]

Central Contacts and Locations

Central contacts

Rebekah J Walker, PhD

716-829-5741rbwalker@buffalo.edu

Jocelyn Stooks, MPH

716-829-2364jstooks@buffalo.edu

Locations

University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Rebekah J Walker, PhD

716-829-5741rbwalker@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Food Insecurity
  • Financial Incentives

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-02-06.