Produce Prescription Program Shows No Benefit for Cardiometabolic Outcomes in Food-Insecure Diabetes Patients

This randomized clinical trial evaluated the effectiveness of a produce prescription program on cardiometabolic health outcomes and healthcare utilization among patients with diabetes at risk for food insecurity. Conducted within an integrated academic health system in the southeastern United States, the study enrolled 2,155 participants who were randomized to receive either the intervention or usual care. The trial followed participants for 12 months, with both groups receiving diabetes self-management educational materials as a baseline component of care.

The intervention consisted of a produce prescription (PRx) program providing participants with a debit card loaded with $80 monthly for up to 12 months to purchase eligible fresh, frozen, or canned fruits, vegetables, and legumes from grocery retailers. The comparator group received usual care plus the same diabetes self-management educational materials. This pragmatic design aimed to test the real-world effectiveness of a food subsidy program within existing healthcare delivery systems.

For the primary outcomes at 12 months, the study found no benefit from the produce prescription program. For HbA1c levels, the adjusted between-arm difference was 0.20 percentage points (95% CI, 0.05%-0.35%) favoring usual care, indicating slightly better glycemic control in the control group. For emergency department visits, the study found no significant between-group differences, though specific effect sizes, absolute numbers, and confidence intervals were not reported for this outcome.

All secondary outcomes similarly showed no significant between-group differences. This included body mass index, blood pressure, and inpatient visits. For each of these outcomes, the study reported no significant differences but did not provide specific effect sizes, absolute numbers, or confidence intervals. The consistent lack of benefit across both primary and secondary outcomes suggests the intervention did not produce measurable improvements in cardiometabolic health or healthcare utilization.

Safety and tolerability findings were not reported in the available data. The study did not provide information on adverse events, serious adverse events, discontinuations, or tolerability issues related to the intervention. This represents a significant gap in the evidence, particularly for a program involving dietary changes and financial incentives that could potentially have unintended consequences.

When compared to prior research on food insecurity interventions for diabetes management, these results contrast with some smaller studies that have shown benefits from food assistance programs. However, this larger, more rigorous trial suggests that simply providing financial resources for healthy foods may not be sufficient to overcome the complex barriers to diabetes management faced by food-insecure populations. The findings align with growing recognition that multifaceted interventions addressing structural, educational, and behavioral factors may be necessary.

Key methodological limitations include moderate benefit use, with only 433 participants (30%) using 80% or more of their monthly allocation. This low utilization rate may have diluted any potential treatment effect and raises questions about implementation barriers. The single-site design in the southeastern US may limit generalizability to other regions or healthcare systems. Additionally, the lack of reported safety data and detailed utilization patterns represents a significant evidence gap.

Clinical implications suggest that clinicians should not expect produce prescription subsidies alone to improve diabetes outcomes in food-insecure patients. While addressing food insecurity remains important for comprehensive diabetes care, this trial indicates that financial assistance for healthy foods may need to be combined with more intensive support, education, or structural interventions to produce measurable clinical benefits. Healthcare systems considering similar programs should anticipate potential implementation challenges and moderate utilization rates.

Unanswered questions include whether higher subsidy amounts, different food categories, or longer intervention durations might yield different results. The optimal combination of food assistance with other support services remains unclear. Future research should explore why utilization was moderate despite financial need, investigate potential subgroup effects, and examine longer-term outcomes beyond 12 months. Additionally, qualitative research could help understand participant experiences and barriers to program use.