Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives

NCT06818669 | Recruiting DMC

• 2 other identifiers: R01MD0187211R01MD018721-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Food Insecurity; Financial Incentives

Outcome Measures

Primary Outcomes (2)

• 10-Year CVD Risk

  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.

  baseline, 3-months, 6-months, and 12-months post randomization

• CVD Risk - PREVENT

  CVD Risk will be measured using the PREVENT equation

  baseline, 3-months, 6-months, and 12-months post randomization

Secondary Outcomes (1)

• Physical and Mental Health Related Quality of Life

  baseline, 3-months, 6-months, and 12-months post randomization

Study Arms (2)

CVD-FIT

EXPERIMENTAL

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: CVD-FIT

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

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.

CVD-FIT

Enhanced Usual Care BEHAVIORAL

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

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Rebekah J Walker, PhD

CONTACT

716-829-5741; rbwalker@buffalo.edu

Jocelyn Stooks, MPH

CONTACT

716-829-2364; jstooks@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized 1:1 to CVD-FIT (a 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) or enhanced usual care (CVD risk reduction education).

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)