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Food is Medicine in Pediatric Patients With Diabetes

The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ready-made meals planned for children with type 1 diabetes, along with food and nutrition advice, can improve health and quality of life and reduce health care visits. It is for children and teens who may have trouble getting enough food or the right foods.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are a current patient at the UMMMC Pediatric Endocrinology Clinic.
  • Are 17 or younger when joining the study.
  • Were diagnosed with type 1 diabetes at least 3 months ago.
  • Have MassHealth or Medicaid health insurance.

Who can't join

  • Have celiac disease, an illness caused by eating gluten, or a severe gluten allergy.
  • Have another health condition that was present at birth, is caused by genes, or is long-lasting.
  • Are in Department of Children and Families (DCF) custody.
  • Are pregnant.
  • Are a prisoner.
  • Do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Celiac disease or severe gluten allergy * Congenital, genetic, or chronic comorbidities * DCF Custody * Pregnant women * Prisoners * Non-English speaking subjects

Study sites (1)

MA