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

NCT06640478 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Lina Huerta Saenz, MD, FAAP · Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640478 on ClinicalTrials.gov