Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT06818669
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CVD-FIT — BEHAVIORAL
    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 — BEHAVIORAL
    Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University at BuffaloBuffaloNew York14203
Rebekah J Walker, PhD
[email protected]
716-829-5741

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By research site
University at Buffalo· Buffalo, NY

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