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

University at Buffalo (UB)

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Behavioral: CVD-FIT; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06818669

1R01MD018721-01A1 (U.S. NIH Grant/Contract)

R01MD018721 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

CVD-FIT

Experimental group

Description:

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.

Treatment:

Behavioral: CVD-FIT

Enhanced Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Usual Care