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Food is Medicine in Pediatric Patients With Diabetes

ConditionsType I DiabetesPediatricsFood Insecurity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Celiac disease or severe gluten allergy

Congenital, genetic, or chronic comorbidities

DCF Custody

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Community Servings

    Other intervention

    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.

  • PedsQL Survey

    Other intervention

    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.

  • Nutrition Counseling

    Other intervention

    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.

  • SDOH Survey

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Community ServingsExperimental treatment 4 interventions
Group B: Standard of Care Pediatric Type I DiabetesActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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).

Time frame
12 months

Secondary outcomes

1

Healthcare Utilization

A secondary outcome measure is the difference in healthcare utilization outcomes between the control and intervention groups. Healthcare utilization will be determined by additional insulin refill requests, urgent care visits, emergency room visits, and hospital admissions during the study and follow-up period.

Time frame
12 months
2

HRQOL Outcomes

A secondary outcome measure is the difference in HRQOL outcomes between the control and intervention groups. HRQOL will be determined by the PedsQL survey for the appropriate age group at timepoints 0, 3, 6, and 12 months.

Time frame
12 months
3

Medically-tailored Meals Sustainability

A secondary outcome measure within the intervention arm only will be a qualitative analysis of the survey responses regarding utility of the Community Servings intervention at conclusion of the intervention to sustainability practices at end of study.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

Source ClinicalTrials.gov

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