Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use: A Randomized Clinical Trial.

Importance: Food-as-medicine programs are becoming increasingly common, and rigorous evidence is needed regarding their effects on health. Objective: To test whether an intensive food-as-medicine program for patients with diabetes and food insecurity improves glycemic control and affects health care use. Design, Setting, and Participants: This stratified randomized clinical trial using a wait list design was conducted from April 19, 2019, to September 16, 2022, with patients followed up for 1 year. Patients were randomly assigned to either participate in the program immediately (treatment group) or 6 months later (control group). The trial took place at 2 sites, 1 rural and 1 urban, of a large, integrated health system in the mid-Atlantic region of the US. Eligibility required a diagnosis of type 2 diabetes, a hemoglobin A1c (HbA1c) level of 8% or higher, food insecurity, and residence within the service area of the participating clinics. Intervention: The comprehensive program provided healthy groceries for 10 meals per week for an entire household, plus dietitian consultations, nurse evaluations, health coaching, and diabetes education. The program duration was typically 1 year. Main Outcomes and Measures: The primary outcome was HbA1c level at 6 months. Secondary outcomes included other biometric measures, health care use, and self-reported diet and healthy behaviors, at both 6 months and 12 months. Results: Of 3712 patients assessed for eligibility, 3168 were contacted, 1064 were deemed eligible, 500 consented to participate and were randomized, and 465 (mean [SD] age, 54.6 [11.8] years; 255 [54.8%] female) completed the study. Of those patients, 349 (mean [SD] age, 55.4 [11.2] years; 187 [53.6%] female) had laboratory test results at 6 months after enrollment. Both the treatment (n = 170) and control (n = 179) groups experienced a substantial decline in HbA1c levels at 6 months, resulting in a nonsignificant, between-group adjusted mean difference in HbA1c levels of -0.10 (95% CI, -0.46 to 0.25; P = .57). Access to the program increased preventive health care, including more mean (SD) dietitian visits (2.7 [1.8] vs 0.6 [1.3] visits in the treatment and control groups, respectively), patients with active prescription drug orders for metformin (134 [58.26] vs 119 [50.64]) and glucagon-like peptide 1 medications (114 [49.56] vs 83 [35.32]), and participants reporting an improved diet from 1 year earlier (153 of 164 [93.3%] vs 132 of 171 [77.2%]). Conclusions and Relevance: In this randomized clinical trial, an intensive food-as-medicine program increased engagement with preventive health care but did not improve glycemic control compared with usual care among adult participants. Programs targeted to individuals with elevated biomarkers require a control group to demonstrate effectiveness to account for improvements that occur without the intervention. Additional research is needed to design food-as-medicine programs that improve health. Trial Registration: ClinicalTrials.gov Identifier: NCT03718832.