NCT06818669

Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives

Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives (CVD-FIT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Overview: 200 African American adults at risk for CVD with food insecurity will be randomized 1:1 to CVD-FIT or enhanced usual care (CVD risk reduction education). Each patient will be followed for 12 months, with study visits at baseline, 3, 6, and 12 months. The primary outcome will be 10-year CVD risk using the Pooled Cohort Equation at 12 months post-randomization while the secondary outcomes will be quality of life at 12 months post-randomization and cost-effectiveness of the CVD-FIT intervention compared to enhanced usual care. 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

• Cardiovascular Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-06-30
• Completion: 2031-06-30
• First posted: 2025-02-10
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States