Nutrition and Counseling for Type 1 Diabetes
(NUTRI-Beta Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used non-insulin therapies or certain medications affecting glucose levels within 30 days before the trial.
What data supports the effectiveness of the treatment Weekly Free Healthy Foods + Intensive Nutrition Counseling for Type 1 Diabetes?
Research shows that educational programs on carbohydrate counting can improve dietary knowledge and habits in people with Type 1 diabetes, leading to better management of blood sugar levels. Additionally, family-based interventions that include motivational interviewing and problem-solving have been effective in improving dietary intake and glycemic control in youth with Type 1 diabetes.12345
Is the Nutrition and Counseling treatment for Type 1 Diabetes safe for humans?
The research articles suggest that nutrition education and counseling, including programs focused on improving dietary knowledge and carbohydrate counting, are generally safe for people with Type 1 diabetes. These programs have been shown to improve dietary habits and knowledge without reported safety concerns.34567
How does the treatment 'Weekly Free Healthy Foods + Intensive Nutrition Counseling' differ from other treatments for type 1 diabetes?
This treatment is unique because it combines the provision of free healthy foods with intensive nutrition counseling, focusing on improving dietary habits and nutritional knowledge, which can lead to better diabetes control. Unlike standard treatments that primarily focus on medication and insulin management, this approach emphasizes lifestyle changes and education to enhance overall health outcomes.4891011
What is the purpose of this trial?
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 ≤ 60daysIntervention/Treatment:- Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks
Research Team
Lina Huerta Saenz, MD, FAAP
Principal Investigator
Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine
Eligibility Criteria
This trial is for children recently diagnosed with stage 3 Type 1 Diabetes (within the last 45 days). It's designed to see if a combination of free healthy foods and intensive nutrition counseling, along with standard insulin therapy, can help manage their condition better than just standard advice.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline visit including enrollment and initial assessments
Treatment
Participants receive weekly distribution of healthy foods and intensive nutrition counseling for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Weekly Free Healthy Foods + Intensive Nutrition Counseling
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
Penn State University
Collaborator