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

Study acronym: NUTRI-Beta
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Oct 30, 2026 to Jun 30, 2026
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 1 of 2 sites
    • Study description expanded, about 2 words
  2. Primary and study completion pushed from Jun 30, 2026 to Oct 30, 2026v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v6
  4. Trial status: Active, Not Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2025 to Jun 30, 2026
    • Study completion date: Dec 31, 2025 to Jun 30, 2026
    • Study description revised
    • Site details revised at 2 of 2 sites
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v4
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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Oct 30, 2025 to Sep 30, 2025
    • Start date changed from estimate of Dec 1, 2024 to Nov 20, 2024
    • Eligibility criteria revised
    • Study description revised
  2. Start date: Oct 15, 2024 to Dec 1, 2024v2 Show 8 more changesShow less
    • Primary completion date: Sep 30, 2025 to Oct 30, 2025
    • Interventions: Active Comparator: Intervention Group (Other) to Free weekly produce foods (Dietary Supplement), NUTRI-Beta Counseling (Other), Standard dietary counseling (Dietary Supplement)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (46)
    • Study description expanded, about 24 words
    • Site contact updated
    • Study title revised
    • Collaborators shortened, about 3 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06640478
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)		 Type 1 Diabetes
Related terms Diabetes Mellitus, Type 1
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov