Diet-sensitive interventions that address food access—often called Food Is Medicine strategies—have potential to improve clinical outcomes and reduce social needs for patients with diet-related illnesses. Despite promise, randomized evidence for medically tailored grocery programs in patients with type 2 diabetes has been limited. This trial evaluated whether provision of medically tailored groceries (MTG) plus supportive resources improves glycemic control and food-related outcomes among Medicaid-insured adults with elevated hemoglobin A1c (HbA1c).
Between November 2021 and July 2022, investigators enrolled 460 Medicaid-insured adults with type 2 diabetes in southern California who had at least two HbA1c measurements ≥7.5% in the prior year. Participants were randomized 1:1:1 to usual care (N = 153), lower-dose MTG (N = 153), or higher-dose MTG (N = 154) for a 6-month intervention period. The prespecified primary analysis compared the combined MTG groups with control.
The primary outcome was change in HbA1c at 6 months. Secondary outcomes included changes in food security and nutrition security assessed by surveys, and changes in hypertension and body mass index (BMI) measured during routine clinical encounters. The trial also prespecified a dose-response comparison between lower- and higher-dose MTG arms and planned subgroup analyses.
MTG were delivered weekly to participants’ homes. The food provided emphasized healthy produce and was scaled to household size. Monthly monetary equivalents for the lower-dose arm ranged from $100 to $170, and for the higher-dose arm from $135 to $210. In addition to groceries, participants received matched recipes and access to telenutrition counseling. Engagement metrics included self-reported consumption of provided food and participation in telenutrition sessions.
At baseline the mean (SD) age was 59.2 (13.2) years; 284 participants (64.8%) were women; 373 (85.2%) reported Hispanic ethnicity. A majority experienced food-related need, with 254 participants (58%) reporting food insecurity at enrollment. Mean baseline HbA1c was 9.40% (SD 1.53).
Among those randomized to intervention, 244 participants (83.3%) reported eating most or all of the food provided, and 63 participants (21.5%) engaged in telenutrition counseling during the intervention period.
Over 6 months, mean HbA1c declined by 0.66 percentage points in the combined MTG intervention arms and by 0.25 percentage points in the usual-care control group. The estimated treatment difference was -0.40 points (95% CI, -0.73 to -0.08), which met statistical significance (P = 0.016). Both lower-dose and higher-dose MTG produced similar reductions in HbA1c; a clear dose-response effect was not observed.
Provision of MTG significantly improved participants’ odds of reporting food and nutrition security. Odds of achieving food security increased (OR 2.12; 95% CI, 1.13–3.99; P = 0.020), and odds of achieving nutrition security increased more markedly (OR 3.65; 95% CI, 1.84–7.25; P < 0.001).
There were no significant changes in measures of hypertension or body mass index over the study period between intervention and control groups.
Higher-dose and lower-dose MTG resulted in similar improvements in HbA1c, indicating no meaningful dose-response within the ranges provided. Prespecified subgroup analyses by sex, education, baseline food security, baseline nutrition security, and baseline HbA1c level showed consistent results across these groups.
Analyses that adjusted for baseline demographics, food insecurity, nutrition insecurity, self-reported health, comorbidities, and medication changes produced findings similar to the primary unadjusted results, supporting robustness of the observed treatment effects.
In this randomized controlled trial of 460 Medicaid-insured, racially/ethnically diverse adults with type 2 diabetes and elevated baseline HbA1c, a 6-month program of medically tailored groceries delivered weekly, combined with recipes and optional telenutrition, lowered HbA1c by a modest but statistically significant amount compared with usual care and substantially improved both food security and nutrition security. No significant effects were observed for hypertension or BMI, and higher vs lower grocery dose did not materially change outcomes.
The trial is registered on ClinicalTrials.gov (NCT05407376). Key topics reported include Food Is Medicine, diabetes, health care, health equity, nutrition, and treatment.
Conflicts disclosed by authors included research funding to several investigators from government and industry sources and consultancy or advisory relationships for some authors. Specific funding and advisory relationships were described in the source report. The other authors reported no conflicts of interest.