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ACTIVE NOT RECRUITING
NCT06640478
NA

A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)

Sponsor: Milton S. Hershey Medical Center

View on ClinicalTrials.gov

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

OTHER

NUTRI-Beta Counseling

Dietary Counseling focused on anti-inflammatory foods

DIETARY_SUPPLEMENT

Standard dietary counseling

Standard of Care therapy: Nutrition counseling per the ADA clinical guidelines and USDA MyPlate model

DIETARY_SUPPLEMENT

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