Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) - Study protocol for a randomized controlled trial.

BACKGROUND:There is strong evidence that disparities in the burden of diabetes exist by both race and poverty. Food insecurity, or an inability to or limitation in accessing nutritionally adequate food, is an important modifiable social determinant of health, particularly in adults with chronic disease. African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure. METHODS:We describe a 4-year ongoing randomized controlled trial, which will test the separate and combined efficacy of monthly food vouchers and monthly food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, African Americans with type 2 diabetes mellitus using a 2 × 2 factorial design. Three hundred African American adults with clinical diagnosis of diabetes and HbA1c ≥ 8% will be randomized into one of four groups: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus stock boxes; and 4) diabetes education plus combined food vouchers and stock boxes. Our primary hypothesis is: among low-income, food insecure, African Americans with type 2 diabetes, those receiving diabetes education enhanced with food supplementation (food vouchers alone, stock boxes alone, or combination) will have significantly greater reduction in HbA1c at 12 months compared to those receiving diabetes education only. DISCUSSION:Results from this study will yield valuable insight currently lacking on how best to design and deliver diabetes interventions to low-income, food insecure, African Americans with diabetes that takes into account both clinical and social determinants of health. TRIAL REGISTRATION:This study was registered on November 29, 2019 with the United States National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT04181424).