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Not yet recruiting Not applicable NCT07535502

Food is Medicine in Pediatric Patients With Diabetes

No applicable phase (e.g. observational)
Conditions: Type I Diabetes Pediatrics Food Insecurity

Sponsor: University of Massachusetts, Worcester

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Community Servings
OTHER
PedsQL Survey
OTHER
Nutrition Counseling
OTHER
SDOH Survey
OTHER
Locations 1
United States (1)
UMass Memorial Children's Medical Center
Worcester , Massachusetts
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
5 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
20.05.2026
Completion date
31.12.2029
Registry ID
NCT07535502
Source
clinicaltrials.gov
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