Planned Eating Patterns for Type 1 Diabetes

No longer recruiting at 1 trial location

Overseen By Angelica Cristello Sarteau, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Metabolic disorders, Unstable thyroid, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an individualized eating plan to help young people with type 1 diabetes manage their blood sugar levels more effectively. Participants will collaborate with a dietitian to create a personalized eating schedule, focusing on meal timing, frequency, and carbohydrate intake throughout the day. The trial seeks teens aged 12-17 who have had type 1 diabetes for at least a year and are experiencing blood sugar levels outside the ideal range (HbA1c between 7.5-11%). Teens must be prepared to follow this eating plan for six months and log their meals using an app like MyFitnessPal. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies tailored for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on an eating strategy for managing diabetes.

What prior data suggests that this individualized eating strategy is safe for youth with type 1 diabetes?

Research shows that personalized meal planning can safely help manage health conditions. In the MyPlan study, researchers create a meal plan tailored to each person's needs. Studies have found that these personalized plans help meet dietary goals without causing harm. Although specific safety data for the MyPlan approach is not yet available, meal planning is generally low-risk when done with professional guidance. Participants in this study will work with a dietitian, ensuring the plan is safe and suitable for each person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MyPlan approach because it offers a personalized way to manage Type 1 diabetes in adolescents. Unlike traditional methods that often emphasize general dietary guidelines, MyPlan pairs youth with a dietitian to tailor an individualized eating plan. This plan helps set and refine action plans focused on specific eating behavior goals, making it more adaptable to each person's lifestyle and needs. By focusing on personalized support and structured eating habits, MyPlan aims to improve adherence and outcomes, which could offer a more effective and sustainable way to manage the condition.

What evidence suggests that the MyPlan eating strategy is effective for improving glycemic levels in youth with type 1 diabetes?

Research shows that personalized eating plans can help manage type 1 diabetes, especially in young people. This trial will evaluate the "MyPlan" approach, which aims to improve eating habits, such as meal timing and frequency, crucial for controlling blood sugar. The plan emphasizes consistent meal times and carbohydrate intake, leading to better blood sugar levels. Another study found that personalized eating plans can also enhance emotional health, which is important for maintaining long-term dietary changes. Early evidence suggests that MyPlan could help teenagers with type 1 diabetes manage their condition better through structured eating patterns. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth J Mayer-Davis, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Sarah Couch, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

Inclusion Criteria

HbA1c 8-11%

HbA1c 7.5-11%

Participants must be between 12 and 17 years old.

Exclusion Criteria

Unwillingness to follow a personalized eating plan for 6 months or complete MyFitnessPal logs at least 3 days/week throughout the study.

Females who are pregnant, breast feeding, planning to become pregnant during the study period or delivered a baby in the last 12 months.

You have other medical conditions such as thyroid problems, eating disorders, or serious health conditions that make it inappropriate for you to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessment of glycemic levels and dietary habits

2 weeks

Treatment

Participants follow the 'MyPlan' individualized eating strategy with telehealth counseling

6 months

Weekly telehealth sessions for 2 months, then bi-weekly for 4 months

Follow-up

Participants are monitored for changes in glycemic levels and adherence to the eating plan

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MyPlan - Individualized Eating Pattern
• MyPlan - Individualized Structured Eating Plan

How Is the Trial Designed?

Group I: "MyPlan" - Individualized Planned Eating Pattern Experimental Treatment 1 Intervention

All youth enrolled in the study will receive the 6-month MyPlan behavioral intervention. Youth and their guardian will be paired with a dietitian to individualize the eating pattern and receive support in setting and refining action plans focused on adhering to the five eating behavior goals that define the eating pattern.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Published Research Related to This Trial

There is no one-size-fits-all meal plan for people with diabetes; nutrition therapy must be tailored to each individual's health goals, preferences, and circumstances.

Effective nutrition interventions should focus on a variety of minimally processed, nutrient-dense foods and provide practical tools for sustainable behavior change in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition therapy recommendations for the management of adults with diabetes. Evert, AB., Boucher, JL., Cypress, M., et al.[2022]

A new tool for managing fat-controlled diets allows for personalized dietary recommendations based on individual food preferences, rather than rigidly restricting certain foods.

This approach groups commonly eaten foods by their fat content, enabling patients to adjust their diets while still adhering to fat control guidelines, making it easier to follow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tool for individualized management of fat-controlled diets. Jansen, C., Dupont, J., Blaker, GG.[2006]

The revised Exchange List for Meal Planning emphasizes a high-carbohydrate, high-fiber diet for individuals with diabetes, reflecting updated nutritional recommendations and improving educational utility.

A new simplified meal planning tool, Healthy Food Choices, was developed to aid in initial education, grouping foods by calories and allowing nutrition counselors to customize meal plans for clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exchange lists: revised 1986. Franz, MJ., Barr, P., Holler, H., et al.[2009]

A 10-week personalized systems nutrition (PSN) program involving 82 healthy participants led to significant reductions in calorie intake and various unhealthy dietary components, resulting in decreased body weight, BMI, and body fat.

The program was particularly effective for individuals with lower phenotypic flexibility, showing notable reductions in LDL and total cholesterol levels, suggesting that personalized nutrition can effectively target behavior change in health-compromised groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Personalized Systems Nutrition Program Improves Dietary Patterns, Lifestyle Behaviors and Health-Related Outcomes: Results from the Habit Study. de Hoogh, IM., Winters, BL., Nieman, KM., et al.[2021]

In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting over 75% of their energy requirements, compared to 76% in the historical intervention group.

The intervention group also showed a significant increase in mean energy and protein intake, with 31 kcal/kg and 1.2 g protein/kg, respectively, indicating that this combined approach is more effective than using a protein-enriched menu alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. Munk, T., Bruun, N., Nielsen, MA., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-11-2021-93cea

"MyPlan" - Individualized Planned Eating Patterns for ... This trial tests a personalized meal plan called 'MyPlan' for young people with type 1 diabetes who struggle with blood sugar control. The plan involves ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4791527/

Effect of the Web-Based Intervention MyPlan 1.0 on Self ... A greater increase in fruit and vegetable intake was found when the Web-based intervention MyPlan 1.0 was used compared to usual care of health ...

3. researchgate.net researchgate.net/publication/392477697_Evaluating_behavioral_goals_for_eating_timing_frequency_and_distribution_of_daily_carbohydrate_consumption_among_youth_with_type_1_diabetes_MyPlan_A_single_arm_pilot_and_feasibility_study

Evaluating behavioral goals for eating timing, frequency ... The objective of the study was to investigate the association between emotional eating and psychosocial health in Spanish adolescents. Cross‐ ...

4. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-025-01303-0

A personalized approach to understanding food cravings and ... The planned approach addresses the limitations of traditional group-level methods, providing insights into eating-related behaviors and outcomes ...

5. mdpi.com mdpi.com/2227-9067/10/2/259

Study of Different Personalised Dietary Plans on Eating ... The objective of this research was to evaluate the effects of different personalised dietary plans on psychological factors in young professional female ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10436119/

Personalized Flexible Meal Planning for Individuals With ... We designed an AI-powered meal planner that helps people create healthy and personalized meal plans based on their health conditions, preferences, and status.

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-08901-4

Adapting the myPlan safety app to respond to intimate partner ... Based on input data, a personalized safety plan with relevant referral information is generated from the evidence-based algorithm designed for ...

8. arxiv.org arxiv.org/html/2502.20601v1

NutriGen: Personalized Meal Plan Generator Leveraging ... This approach ensures that meal plans align with individual dietary goals while incorporating features such as calorie counts, alternative food ...

9. mdpi.com mdpi.com/2072-6643/17/9/1492

Improving Personalized Meal Planning with Large ... Background/Objectives: Identifying and decomposing compound ingredients within meal plans presents meal customization and nutritional analysis challenges.

10. researchgate.net researchgate.net/publication/391214299_Meal-Plan_App_Personalized_Meal_Plans_Based_on_Unique_Needs

Personalized Meal Plans Based on Unique Needs Meal-Plan App: Personalized Meal Plans Based on Unique Needs. April ... (data and knowledge-based) and producing a complex structured output.