Food Rx + CHW: a community health worker-led medically tailored grocery intervention to address food insecurity and type 2 diabetes, a pilot randomized trial

BACKGROUND: Food insecurity increases an individual's risk of poor health outcomes from costly and preventable chronic diseases such as type 2 diabetes. METHODS: In this pilot study, primary care patients with self-reported food insecurity and a diagnosis of type 2 diabetes received 12 weekly home deliveries of fresh produce and shelf-stable foods. About half of the participants were also supported by a community health worker (CHW) providing nutrition education, cooking instruction, and resource linkages (Food + CHW). Participants (n=31) self-checked hemoglobin A1C, blood pressure, and weight on devices at home at three time points: baseline, three months, and six months. RESULTS: Participants (84% female, 32% Black, 66% White, 22% Hispanic, and 58 years old on average) had an average HbA1c of 8%. For the Food-only group (n=15), there was no significant change in hemoglobin A1c at either time point. For the Food + CHW group (n=16), the mean change in HbA1c was -0.85 (95% CI, [-0.048, -1.66], P value = 0.039) from baseline to 3 months and -1.65 (95% CI, [-2.84 - 0.472], P value = 0.012) from baseline to 6 months and a majority of participants (81%) had a reduction in hemoglobin A1c at six months. Diastolic blood pressure for the Food-only group increased by an average of 6.5 mmHg (p= 0.02) between baseline and 3 months but remained stable for the Food + CHW group. In both groups, systolic blood pressure and weight did not change significantly. Participants in the Food + CHW group reported significant increases in daily servings of fruit, nutrition label reading, eating meals cooked from scratch, and farmer's market shopping while the Food-only group did not. CONCLUSION: These findings suggest that CHWs support a patient's ability to reduce hemoglobin A1c through dietary behavior changes and sustain this reduction over time.​ This trial was retrospectively registered at ClinicalTrials.gov (NCT06476990) on June 20, 2024.