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

ABSTRACT

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.