Food is Medicine in Pediatric Patients With Diabetes

Summary

The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.

Conditions

• Type I Diabetes
• Pediatrics
• Food Insecurity

Interventions

OTHER

Nutrition Counseling

Participants will recieve standare-of-care nutrition counseling from a registered dietician with the UMass Pediatric Endocrinology clinic to receive education and review dietary and nutrition recommendations personalized to the patient and management of Type I diabetes.

OTHER

Community Servings

Participants randomized to the intervention group will receive the Community Servings medically-tailored meal plan for the first 6 months after enrollment. The Community Servings plan will provide 10 medically-tailored meals per week, delivered to the participant residence on the day of the week preferred by the participant. Following enrollment, participants will meet with a Community Servings team member to review dietary restrictions. The meals were designed by Registered Dieticians for children and adolescents with Type 1 Diabetes and will be prepared and distributed by the Community Servings team. Participants in the intervention arm will also be asked to complete a survey on the utility of the Community Servings intervention at the conclusion of the program, 6 months after initial enrollment. The survey and responses will be housed in the REDCap.

OTHER

PedsQL Survey

All participants or their parents will complete a baseline quality of life assessment appropriate for their age group and again at 3 months, 6 months, and at end of follow-up at 12 months. The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. This model integrates multidimensional physical, emotional, social, and school functioning scales and reports total, physical health, and psychological health summary scores. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database.

OTHER

SDOH Survey

All participants or their parents will complete a baseline social driver of health (SDOH) survey at the time of enrollment and again at 3 months, 6 months, and at end of follow-up at 12 months. The SDOH survey is provided for all patients at UMass and evaluates the risk for food, housing, utility, and transportation concerns. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database.

Sponsors & Collaborators

• University of Massachusetts, Worcester

  lead OTHER

Principal Investigators

• Lawrence Rhein, MD, MPH · UMass Chan Medical School

• Arvin Garg, MD, MPH · UMass Chan Medical School

• Leslie Soyka, MD · UMass Chan Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-03

Primary Completion

2027-12-31

Completion

2029-12-31

Countries

• United States

Study Locations