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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: CVD-FIT; Behavioral: Enhanced Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebekah J Walker, PhD; Phone Number: 716-829-5741; Email: rbwalker@buffalo.edu
• Study Contact Backup: Name: Jocelyn Stooks, MPH; Phone Number: 716-829-2364; Email: jstooks@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo
      • Contact: Rebekah J Walker, PhD; Phone Number: 716-829-5741; Email: rbwalker@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Enhanced Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and Mental Health Related Quality of Life	Quality of Life will be measured using the SF-12 questionnaire and reported as physical health related and mental health related scores (score ranges from 0 to 100 with higher numbers indicating better quality of life)	baseline, 3-months, 6-months, and 12-months post randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Food Insecurity; Financial Incentives
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: R01MD018721 (U.S. NIH Grant/Contract); 1R01MD018721-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data will not be shared to protect privacy of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No