Food is Medicine for Children with Type 1 Diabetes
This study is looking at whether providing special meals can help children and teenagers with Type 1 Diabetes. It's called "Food is Medicine in Pediatric Patients With Diabetes." Participants will receive 10 medically-tailored meals per week from Community Servings for 6 months. They will also get standard nutrition counseling from a registered dietitian. The study aims to see if these meals improve health outcomes related to nutrition and diabetes, and also improve their quality of life. We are looking for about 50 children and teenagers, aged 5 to 17, who have Type 1 Diabetes, are current patients at UMMMC Pediatric Endocrinology Clinic, have had diabetes for at least 3 months, and have public health insurance. The study will measure these improvements over 12 months. The current status of the study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 50 participants. Participants will be randomly assigned to either receive the Community Servings meal plan or not.
- What's involved
- Participants will receive 10 medically-tailored meals per week for 6 months and nutrition counseling. They will also complete quality of life and social driver of health surveys at baseline, 3 months, 6 months, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months, with assessments at 3, 6, and 12 months after enrollment.
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Food is Medicine in Pediatric Patients With Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lawrence Rhein, MD, MPH · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School
- Arvin Garg, MD, MPH · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School
- Leslie Soyka, MD · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School
Who to contact
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Do you actually qualify for this trial?
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What this trial measures
- Difference in nutrition-related clinical outcomes12 months
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.
- Difference in Diabetes-related clinical outcomes12 months
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).