Cardiovascular Risk Reduction for Adults with Food Insecurity Using Structured Incentives (CVD-FIT) - ABSTRACT Cardiovascular disease (CVD) is associated with significant morbidity and mortality, decreased quality of life, and increased health care utilization and cost. Food insecurity, defined as limited or uncertain access to adequate food for an active, healthy life, is reported by nearly one third of adults with cardiovascular disease in the United States and is associated with increased 10-year cardiovascular disease risk and increased risk of death. Current interventions in adults with food insecurity focus on identification and referral, food supplementation, or access to food options at the community level through grocery stores or rebates. However, these interventions do not address poverty as an underlying driver of food insecurity and do not target long- term CVD risk reduction, especially in African Americans. As a result, there is an urgent need to develop interventions that address food insecurity and account for underlying poverty while targeting CVD risk factor reduction. Two emerging research areas that have the potential to bridge the gap in terms of anchoring food insecurity within poverty and targeting CVD risk reduction are income supplementation and behavioral economics. Income supplementation focuses on providing supplemental income to support immediate consumption, maintain a basic living standard, or build long-term security. Evidence from recent studies show that small amounts of income supplementation (~$100/month) are associated with significant reduction in food insecurity. Preliminary data from our group and a pilot study of the proposed intervention suggests feasibility, acceptability, and preliminary efficacy in improving outcomes among food insecure adults. The proposed study - Cardiovascular risk reduction for adults with food insecurity using structured incentives (CVD-FIT) - will test 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. 200 African American at risk for CVD with food insecurity will be randomized 1:1 to CVD-FIT or enhanced usual care (CVD risk reduction education). Primary outcomes include 10-year CVD risk reduction, quality of life, and cost effectiveness. AIM 1: Test the efficacy of CVD-FIT on improving 10-year CVD risk in African Americans at risk for CVD with food insecurity using the Pooled Cohort Equations. AIM 2: Test the efficacy of CVD-FIT on improving quality of life in African Americans at risk for CVD with food insecurity. AIM 3: Test the cost- effectiveness of CVD-FIT in in African Americans at risk for CVD with food insecurity. Exploratory analyses will examine mediators (e.g., HbA1c, blood pressure, lipids, healthy eating index, perceived stress) and moderators (e.g., age, sex, socioeconomic status) on intervention effect.
