20 Participants Needed

Nutrition and Counseling for Type 1 Diabetes

(NUTRI-Beta Trial)

Recruiting at 1 trial location
LH
EN
LH
Overseen ByLina Huerta Saenz, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

LH

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

Willing and able to give assent and to have a parent or legal guardian to provide informed consent
I have tested positive for at least one type 1 diabetes autoantibody.
Willing and able to give assent and have a parent or legal guardian provide informed consent
See 5 more

Exclusion Criteria

I haven't taken any diabetes-affecting meds in the last 30 days.
Prior diagnosis or positive screening of food sensory disorders
I have used non-insulin treatments for high blood sugar in the last 30 days.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Baseline visit including enrollment and initial assessments

1 day
1 visit (in-person)

Treatment

Participants receive weekly distribution of healthy foods and intensive nutrition counseling for 12 weeks

12 weeks
7 visits (4 in-person, 3 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Weekly Free Healthy Foods + Intensive Nutrition Counseling
Trial Overview The study tests whether providing weekly healthy foods and detailed nutrition guidance improves the management of Type 1 Diabetes in children. The goal is to extend the 'honeymoon phase', where diabetes is easier to control, compared to usual care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of care nutrition counseling (MyHealthy plate model and ADA clinical guidelines)Experimental Treatment1 Intervention
STANDARD OF CARE NUTRITION COUNSELING: 1. A 12-week distribution of weekly grocery store gift cards of similar monetary value of the NUTRI-Beta food bag in addition to 2. MyPlate USDA model with similar frequency of nutrition counseling visits but following the American Dietary Association (ADA) Guidelines, and 3. Standard insulin treatment (either insulin injections or insulin pump per patient preference) and 24-hour continuous glucose monitor
Group II: NUTRI-Beta Intervention GroupActive Control2 Interventions
We will provide healthy foods (NUTRI-Beta Food bag) to the intervention group weekly for 12 weeks, in addition to an intensive nutrition counseling program (NUTRI-Beta Counseling) and close 24-hour continuous glucose monitoring. The healthy foods bag will contain a combination of 6 types of foods including: 1. seasonal fruits (containing high amounts of vitamin C and E) 2. legumes, 3. nuts, 4. yogurt, and 5. seasonal vegetables (carotenoids, tomatoes, broccoli, celery, etc.). 6. seafood or seafood-related products The portions of each food group component of the NUTRI-Beta basket will follow the current USDA dietary guidelines according to the age of the participant: a) Intervention group will receive NUTRI-Beta foods bag + intensive nutrition counseling (NUTRI-Beta dietary counseling) + standard insulin treatment (either insulin injections or insulin pump per patient preference) and T1D technology use

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

Penn State University

Collaborator

Trials
380
Recruited
131,000+

Findings from Research

This scoping review analyzed 22 articles and eight systematic reviews on nutrition management for children and adolescents with type 1 diabetes, revealing a focus on carbohydrate counting and dietary intake patterns rather than personalized dietary counseling.
Only four studies included tailored nutrition interventions, highlighting a significant gap in research regarding the effectiveness of individualized medical nutrition therapy for long-term management in young patients.
Nutrition Interventions in Pediatric Patients with Type 1 Diabetes: An Evidence Analysis Center Scoping Review.Handu, D., Piotrowski, M.[2022]
Individuals with type 1 diabetes require personalized nutrition therapies to enhance their health and metabolic outcomes, but many are not following recommended dietary guidelines.
Various meal planning strategies, such as basic nutrition guidelines and carbohydrate counting, have been proposed to help patients better manage their diets, although the effectiveness of these interventions remains uncertain.
Dietary strategies for adult type 1 diabetes in light of outcome evidence.Matteucci, E., Giampietro, O.[2021]
A simple educational program significantly improved dietary knowledge and carbohydrate (CHO) counting skills in 48 Type 1 diabetes patients over four interactive meetings, leading to better management of their condition.
The improvements in dietary knowledge and CHO management persisted for at least 7 months after the course, indicating that such educational interventions can establish lasting habits for better diabetes control.
Teaching and training programme on carbohydrate counting in Type 1 diabetic patients.Bruttomesso, D., Pianta, A., Crazzolara, D., et al.[2019]

References

Nutrition Interventions in Pediatric Patients with Type 1 Diabetes: An Evidence Analysis Center Scoping Review. [2022]
Dietary strategies for adult type 1 diabetes in light of outcome evidence. [2021]
Teaching and training programme on carbohydrate counting in Type 1 diabetic patients. [2019]
Improving dietary quality in youth with type 1 diabetes: randomized clinical trial of a family-based behavioral intervention. [2022]
Evaluation of a psycho-educational nutritional program in diabetic patients. [2022]
Nutrition education for risk factor reduction and patient education: a review. [2019]
Pediatric, adolescent, and young-adult nutrition issues in IDDM. [2019]
Effect of nutritional counseling on the blood glucose and nutritional knowledge of diabetic subjects. [2019]
Diabetes and nutrition recommendations: a practical perspective. [2008]
10.United Statespubmed.ncbi.nlm.nih.gov
Individualized diets for diabetic patients. [2019]
Dietary Intake and Adherence to the Recommendations for Healthy Eating in Patients With Type 1 Diabetes: A Narrative Review. [2022]
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