Abstract 14690: ProduceRX Clinical Trial

Abstract

Background: Nutrition related cardiometabolic diseases are leading causes of morbidity, health disparities and health care spending. Produce prescriptions are highly promising to address these issues but impacts on health outcomes have not been tested in a randomized controlled trial. Hypothesis: A pre-randomized controlled trial that provides 6 months of free weekly produce deliveries to the intervention group reduces hemoglobin A1c (HbA1c), body mass index (BMI), and blood pressure (BP), among Medicaid patients with type 2 diabetes (T2DM) and persistently elevated HbA1c when compared to the control group. Methods: A total of 450 eligible Kaiser Permanente Southern California patients were enrolled 1:1:1 into control, high- and low-dose intervention groups. Eligibility criteria included: being enrolled through Medicaid (MediCal), age 18+ years, having T2DM with at least two HbA1c values > 7.5% in the past 12 months. Produce amounts were scaled to household size and ranged from $90-270 and $90-180 for high and low-dose households, respectively. The primary endpoint was change in HbA1c at 6 months (measured up to 90 days post-intervention). Secondary outcomes were changes in BMI and BP. Primary analysis assessed both intervention groups compared to control; exploratory analyses considered dose-response. Analysis was conducted using random effects models. Results: Participants were predominantly Hispanic (85%), female (65%), and in average 59.4(SD=13.2) years old. At baseline, HbA1c was 9.40% (1.52); BMI 34.1kg/m2 (7.95); 74% had elevated BP or hypertension (stage 1 or 2), 58.3% were food insecure. Baseline characteristics were similar between control and intervention groups, 87% of participants had a 6-month HbA1c measure. In intention-to-treat analysis, compared to control, HbA1c at 6 months was significantly reduced in the intervention group: -0.37 [95%CI:-0.71;-0.04],p=0.028. Reduction in HbA1c was not significantly different between the high- and low-dose intervention. Results for BMI and BP are forthcoming. Conclusion: In the first randomized controlled trial of its kind, a produce prescription program significantly improved HbA1c among low-income patients on Medicaid with poor glycemic control at baseline.