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A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)
Sponsor: Milton S. Hershey Medical Center
Summary
The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, acceptability, and fidelity of this intervention will be measured. We will also explore the likelihood of prolonging the honeymoon phase of T1D in the intervention study group. Comparisons will be made between this combined nutrition intervention and free healthy foods vs. current standard nutrition counseling. Both study groups will receive standard of care treatment for T1D (insulin therapy). The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 of T1D, and may lead to prolongation of the honeymoon phase. The overall goal is to promote the beta cell function survival and to reduce the progression to stage 4 of T1D. Condition or Disease: * Type 1 Diabetes Mellitus * New Diagnosis of Stage 3 Type 1 Diabetes ≤ 60days Intervention/Treatment: \- Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks
Official title: NUTRI-Beta Study: A Pilot Clinical Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-11-20
Completion Date
2026-06-30
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
NUTRI-Beta Counseling
Dietary Counseling focused on anti-inflammatory foods
Standard dietary counseling
Standard of Care therapy: Nutrition counseling per the ADA clinical guidelines and USDA MyPlate model
Free weekly produce foods
Free weekly produce
Locations (2)
Penn State Health Children's
Hershey, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States