Cardiovascular Diseases
Conditions
Keywords
Food Insecurity, Financial Incentives
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.
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
BEHAVIORALCVD-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.
BEHAVIORALEnhanced Usual Care
Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
Sponsors
State University of New York at Buffalo
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-Year CVD Risk | baseline, 3-months, 6-months, and 12-months post randomization | 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. |
| CVD Risk - PREVENT | baseline, 3-months, 6-months, and 12-months post randomization | CVD Risk will be measured using the PREVENT equation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical and Mental Health Related Quality of Life | baseline, 3-months, 6-months, and 12-months post randomization | 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) |
Countries
United States
Contacts
CONTACTRebekah J Walker, PhD
CONTACTJocelyn Stooks, MPH
Outcome results
None listed