Implementation and Effectiveness Outcomes of a Pilot Comparative Effectiveness Randomized Controlled Trial Evaluating...

Area of Science:

• Pediatric Primary Care
• Nutrition Interventions
• Public Health

Background:

• Food Is Medicine (FIM) programs improve diet and food security but lack evidence in pediatric populations.
• Obesity is a growing concern in children, necessitating effective interventions.
• Medicaid-eligible children with elevated BMI are a vulnerable group for nutritional support.

Purpose of the Study:

• To assess the implementation and health outcomes of two FIM strategies in at-risk children.
• To compare the effectiveness of produce vouchers versus home delivery with nutrition education.
• To evaluate feasibility, acceptability, and impact on health markers in a pediatric cohort.

Main Methods:

• Pilot comparative effectiveness randomized trial with 150 Medicaid-eligible children (aged 5-12, BMI ≥85th percentile).
• Three arms: biweekly produce vouchers + education, biweekly produce home delivery + education, or wait-list control.
• Measured implementation outcomes (retention, redemption, etc.) and child health outcomes (diet, BMI z-scores, labs) over 32 weeks.

Main Results:

• High redemption rates for vouchers (88%) and consistent delivery of produce (18 lb/week).
• Parents reported reduced grocery costs with both FIM strategies.
• Voucher group showed a significant decrease in aspartate aminotransferase compared to controls (p=0.006).

Conclusions:

• Food Is Medicine programs are feasible and well-accepted in at-risk pediatric populations.
• The produce voucher model demonstrated slightly higher acceptability.
• Further large-scale studies are needed to confirm effectiveness.