Impact of Medically Tailored Meals on Clinical Outcomes Among Low-Income Adults with Type 2 Diabetes: A Pilot Randomized Trial

Background: Adults with type 2 diabetes (T2DM) and adverse social determinants of health experience barriers to healthful eating, and achieve poorer glycemic control and clinical outcomes. Objective: To examine the impact of medically tailored meals (MTM) with medical nutrition therapy (MNT) on clinical outcomes among adults with DM. Design: Pilot randomized controlled trial. Participants: English-speaking adults with DM and hemoglobin A1c (A1c) levels > 8% insured by Maryland Medicaid plans. Intervention: The treatment group received home delivery of 12 medically tailored, frozen meals and a fresh produce bag weekly for 3 months, and individual calls with a registered dietitian monthly for 6 months in addition to usual care. The control group received usual care. Outcomes were change from baseline to 6 months in A1c (primary), body mass index (BMI), blood pressure, food insecurity, and diabetes-related quality of life, knowledge, and self-efficacy (secondary). Key Results: We randomized 74 adults; 77% completed data collection. The mean age was 48 years, 40% were male, 77% were Black, and the mean A1c was 10.3%. Eighty-six percent of meals were delivered, and on average 4.8 nutrition visits were completed. At 6 months, both groups had similar improvements in A1c (- 0.7 vs. - 0.6%); the control group reported more favorable changes in diabetes medications. Changes in systolic blood pressure and BMI at 6 months did not differ between groups. Diabetes-related quality of life, knowledge, and self-efficacy improved modestly, but not differently by group. Food insecurity decreased significantly from baseline to 3 months in the intervention (53 to 17%) compared to control (48 to 44%; p < 0.05), which lessened but remained significant at 6 months. Conclusions: Recruitment and retention of an at-risk group of adults with DM was feasible. Intervention uptake was good but did not improve clinical outcomes. More comprehensive and clinically integrated interventions are likely needed to achieve significant clinical benefits. ClinicalTrials.gov Registration: NCT04034511.