"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes

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

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 eating meals and snacks at regular times and in specific amounts to help stabilize blood sugar levels. The study will see if this approach is acceptable and effective over several months.

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.

How does the MyPlan - Individualized Eating Pattern treatment differ from other treatments for dietary management?

The MyPlan treatment is unique because it offers a personalized eating plan that considers individual food preferences and lifestyle, unlike traditional rigid dietary plans. It uses a dynamic approach to create meal options that match personal needs and preferences, helping individuals maintain control and motivation to adhere to their nutrition plan. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment MyPlan - Individualized Eating Pattern, MyPlan - Individualized Structured Eating Plan?

Research shows that individualized nutrition plans, which consider personal preferences and health goals, can help people make better food choices and stick to healthier eating patterns. This approach has been effective in managing conditions like diabetes by providing practical tools for long-term dietary changes. ^{1 4 6 7 8}

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Aligning nutrition assistance programs with the Dietary Guidelines for Americans. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Nutrition therapy recommendations for the management of adults with diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Exchange lists: revised 1986. [2009]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dynamic Macronutrient Meal-Equivalent Menu Method: Towards Individual Nutrition Intervention Programs. [2020]

5. United States 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. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Increasing dietary fibre intake in healthy adults using personalised dietary advice compared with general advice: a single-blind randomised controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A tool for individualized management of fat-controlled diets. [2006]

8. Switzerland 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. [2021]