Food is Medicine in Pediatric Patients With Diabetes

NCT07535502 | Not Yet Recruiting

• 1 other identifier: STUDY00002969
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Food is Medicine; Type I Diabetes; Pediatrics; Food Insecurity; Continuous Glucose Monitoring; Medically-tailored Meals

Outcome Measures

Primary Outcomes (2)

• Difference in nutrition-related clinical outcomes

  The primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Nutrition-related outcomes will include growth metrics (Z-score and percentile rank), and height and weight will be combined to report Body Mass Index (BMI) in kg/m\^2 metrics.

  12 months

• Difference in Diabetes-related clinical outcomes

  One primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Diabetes outcomes will include changes in insulin dosage (units/mL/day), continuous glucose monitoring metrics (glucose in mg/dL, time spent at range intervals and variability as percentages), and Hemoglobin A1c (percentage).

  12 months

Secondary Outcomes (3)

• Healthcare Utilization

  12 months

• HRQOL Outcomes

  12 months

• Medically-tailored Meals Sustainability

  12 months

Study Arms (2)

Community Servings

EXPERIMENTAL

The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study.

Other: Community Servings; Other: PedsQL Survey; Other: Nutrition Counseling; Other: SDOH Survey

Standard of Care Pediatric Type I Diabetes

ACTIVE COMPARATOR

The control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study.

Other: PedsQL Survey; Other: Nutrition Counseling; Other: SDOH Survey

Interventions

Community Servings OTHER

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.

Community Servings

PedsQL Survey OTHER

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.

Community Servings; Standard of Care Pediatric Type I Diabetes

Nutrition Counseling OTHER

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.

Community Servings; Standard of Care Pediatric Type I Diabetes

SDOH Survey OTHER

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.

Community Servings; Standard of Care Pediatric Type I Diabetes

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Current patients of the UMMMC Pediatric Endocrinology Clinic
• Children and Adolescents less than or equal to 17 years of age at the time of enrollment
• Diagnosed with Type 1 Diabetes at least 3 months ago
• Public (MassHealth or Medicaid) Health Insurance

You may not qualify if:

• Celiac disease or severe gluten allergy
• Congenital, genetic, or chronic comorbidities
• DCF Custody
• Pregnant women
• Prisoners
• Non-English speaking subjects

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Children's Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (4)

• Erika Hanson, Sara Raza, Katie Garfield, Erin Mizraki, Hannah Rahim, Jessica Samuels, Carmel Shachar, Emily Broad Leib, Alissa Wassung, and Cate Hensley; Food is Medicine: A State Medicaid Policy Toolkit; Harvard Law School Center for Health Law and Policy Innovation and Food is Medicine Coalition

  BACKGROUND

• Drewnowski A, Specter SE. Poverty and obesity: the role of energy density and energy costs. Am J Clin Nutr. 2004 Jan;79(1):6-16. doi: 10.1093/ajcn/79.1.6.

  PMID: 14684391 BACKGROUND

• Gundersen C, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff (Millwood). 2015 Nov;34(11):1830-9. doi: 10.1377/hlthaff.2015.0645.

  PMID: 26526240 BACKGROUND

• Chobot A, Piona C, Bombaci B, Kaminska-Jackowiak O, Mancioppi V, Passanisi S. Exploring the Continuous Glucose Monitoring in Pediatric Diabetes: Current Practices, Innovative Metrics, and Future Implications. Children (Basel). 2024 Jul 27;11(8):907. doi: 10.3390/children11080907.

  PMID: 39201842 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lawrence Rhein, MD, MPH

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

• Arvin Garg, MD, MPH

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

• Leslie Soyka, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline E French, BS, MBE

CONTACT

5088870106; madeline.french2@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist and Pediatric Pulmonologist; Chair, Department of Pediatrics and Associate Professor, UMass Chan Medical School

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)