NCT06640478

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

NUTRI-Beta Study: A Pilot Clinical Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed description

The proposed study is a 12-week pilot, single-blinded, randomized, controlled clinical trial in prepubertal children (6-17 years old) newly diagnosed with stage 3 of type 1 diabetes (T1D) within 60 days. The total duration of the study is 24 weeks, but the nutrition intervention is only delivered during 12 weeks with a 24-week follow up visit. We expect to enroll a total of 12-40 children (6-20 per study group). We will be investigating the potential role of a frequent personalized nutrition counseling intervention (7 sessions in a hybrid model) in addition to weekly distribution of selected healthy foods. We expect the diet quality of the youth receiving the intervention (you) will improve during and after the study intervention. There will be two study groups: intervention and control group. The intervention group will receive a food bag containing specific healthy foods with high anti-inflammatory properties weekly for 12 weeks, in addition to seven nutrition counseling sessions. The provided foods are a combination of 6 types of foods including: a) seasonal fruits (containing high amounts of vitamin C and vitamin E), b) legumes, c) nuts, d) yogurt, e) vegetables and f) seafood. The portions of each food group component of the "healthy foods bag" will follow the current USDA dietary guidelines according to the age of the study participant. \[1\] By contrast, the control group will receive weekly grocery store gift cards of similar monetary value of the "healthy food bag" in addition to seven nutrition counseling sessions based on the standard MyHealthy plate model. In regards to the nutrition counseling sessions, this counseling will be provided as a hybrid model with a combination of 4 in-person nutrition counseling sessions and 3 virtual dietary counseling sessions provided by a registered dietitian. In summary: 1. Intervention group will receive NUTRI-Beta foods basket + nutrition counseling (NUTRI-Beta dietary counseling) + standard insulin treatment (either insulin injections or insulin pump per patient preference)+ standard of care insulin therapy and use of a 24-hour continuous glucose monitor, and 2. Control group will receive the standard nutrition counseling per the American Dietary Association (ADA) Guidelines \[2\] + weekly grocery store gift cards + standard of care insulin therapy and use of a 24-hour continuous glucose monitor. The NUTRI-Beta clinical trial study visits will include a total of 10 visits during the 24 weeks of the study: Screening visit (V0), baseline visit (enrolment visit= V1), nutrition counseling visit 2 (week 2 post enrollment), nutrition counseling visit 3 (V3-virtual, week 3), nutrition counseling visit 4 (V4-in person, week 4), nutrition counseling visit 5 (V5-virtual, week 6), nutrition counseling visit 6 (V6-in person, week 8), nutrition counseling visit 7 (V7-virtual, week 10), visit 8 ( 12 weeks after enrollment- end of nutrition intervention), and visit 9 (24 weeks after enrollment). We expect that this nutrition intervention (NUTRI-Beta) will be acceptable to children with new diagnosis of clinical diabetes (stage 3 of T1D) and will improve their diet intake and quality, their nutrition status and may increase their likelihood of residual beta-cell function in the treatment group. Evaluation of the partial remission of T1D will be completed through the determination of the insulin dose-adjusted A1C (IDAA1C) and residual beta cell function through the measurement of peak C-peptide levels during a 2-hour mixed-meal tolerance test (MMTT) after 12 and 24 weeks of the nutrition intervention. The treatment group is expected to have higher rates of partial remission of T1D measured by the IDAA1C, better diet quality, better glycemic metrics and reduced needs of total daily dose of insulin (TDD) (unit/kg/day).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-10-15
• Last updated: 2026-03-04

Locations

2 sites across 1 country: United States