Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CVD-FIT, Enhanced Usual Care.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives (CVD-FIT)
Overview
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.
Interventions
- 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.
Primary outcome measures
- 10-Year CVD Risk [Time frame: baseline, 3-months, 6-months, and 12-months post randomization]
- CVD Risk - PREVENT [Time frame: baseline, 3-months, 6-months, and 12-months post randomization]
Secondary outcome measures (1)
- Physical and Mental Health Related Quality of Life [Time frame: baseline, 3-months, 6-months, and 12-months post randomization]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University at Buffalo — Buffalo
Identifiers
NCT: NCT06818669 · R01MD018721 · 1R01MD018721-01A1