Skip to main content
OpenTrials
Completed

NCT Number: NCT05147324

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

The purpose of this study is to test the acceptability and effectiveness of an individualized eating strategy as part of diabetes self-management to improve glycemic levels among youth with type 1 diabetes (T1D) and suboptimal glycemic management. Investigators will assess participant acceptability of and adherence to a 6-month individualized eating strategy ("MyPlan") characterized by approximate day-to-day consistency in the frequency and timing of meals and snacks and distribution of carbohydrate throughout the day. Within-individual change in glycemic levels between baseline and 6-months of the study will also be compared. The goal of the study is to inform the design of a future randomized clinical trial to test the addition of the MyPlan eating strategy to ongoing diabetes clinical care among youth with T1D.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Behavior, Animal Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Loading trial locations.

About this study

This is a pilot, single-arm clinical trial to assess whether "MyPlan" is an acceptable and effective dietary strategy to be included in future fully powered trials aimed at optimizing diabetes outcomes in youth with T1D. Youth and guardian dyads will be enrolled for a total of 6 months, during which time dyads will be counseled to follow an individualized eating pattern ("MyPlan") defined by five eating behavior goals: 3-4 meals per day and 1-2 optional snacks; eating occasions no less than 2 hours or greater than 4 hours apart; target carbohydrate ranges for each eating occasion; no post-dinner snacking; eating occasion within 1-2 hours of waking. The plan, including the eating behavior goals, will be tailored to youth and family routines and preferences. Registered dieticians will support participant adherence to the plan via telehealth counseling sessions on a weekly basis for the first 2 months followed by bi-weekly sessions for 4 months. Investigators will assess a) acceptability of the eating pattern and counseling strategy according to youth and guardians; b) youth adherence to the five eating behavior targets; c) change in youth glycemic levels between baseline and 6-months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Youth 12-17 years old
  • History of T1D of at least one year
  • HbA1c 7.5-11%
  • Guardian willing to also participate
  • English as preferred language

Exclusion criteria

  • Youth with other metabolic disorders, unstable thyroid disease, diagnosed eating disorders, prohibitively strict dietary restrictions, or those with other serious condition that renders participation inappropriate.
  • Females who are pregnant, breast feeding, planning to become pregnant during the study period or delivered a baby in the last 12 months.
  • Unwillingness to follow a personalized eating plan for 6 months or complete MyFitnessPal logs at least 3 days/week throughout the study.

Treatment and study plan

"MyPlan" - Individualized Planned Eating Pattern

Behavioral

Sessions involve a structured behavior change counseling module derived from FLEX (NCT01286350), DASH-4-Teens (NCT00585832), and a Social Cognitive Theory and Transtheoretical Model informed conceptual framework, which uses education, motivation and self-efficacy enhancement, goal setting, and problem-solving skills training to initiate and sustain eating pattern adherence. Sessions support incremental progress towards meeting all five eating behavior goals by helping youth develop action plans, troubleshoot barriers to adherence, and refine action plans to improve adherence. Youth log in MyFitnessPal at least three days per week. Logs are used to assess and troubleshoot adherence, support youth in developing and refining action plans, and reward youth with points. Incentives are allocated using a point scheme designed to promote logging and goal achievement. Formal adjustment of the eating pattern is based on adherence according to logs and youth/guardian acceptability.

Other names: "MyPlan"

Primary outcomes

  1. Percent Time in Range (Baseline)

    Time frame: Baseline (Week 0-2)

    Percentage of time spent in the glycemic range of 70-180 mg/dL between Baseline week 0-2 week of blinded continuous glucose monitor (CGM) wear time.

  2. Percent Time in Range (Week 22-24)

    Time frame: Week 22-24

    Percentage of time spent in the glycemic range of 70-180 mg/dL during Week 22-24 of blinded continuous glucose monitor (CGM) wear time.

  3. Adherence to Each Eating Behavior Goal

    Time frame: Between Week 22 and Week 24

    Percentage of participants who adhered to each eating behavior goal assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22-24:

    Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking;

  4. Adherence to 0-5 Eating Behavior Goals

    Time frame: Between Week 22 and Week 24

    Percentage of participants who adhered to 0-5 eating behavior goals assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24.

    Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks Goal 4. No snacking after dinner Goal 5. Meal/snack consumed ≤2 hours of waking

  5. Mean Adherence to Overall Eating Behavior Pattern

    Time frame: Between Week 22 and Week 24

    Mean number of eating behavior goals (range: 0-5) adhered to by participants as assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24:

    Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking;

  6. Mean Acceptability Score (Youth)

    Time frame: Week 26

    Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable).

  7. Acceptability Percentage (Youth)

    Time frame: Week 26

    Percentage of youth with a mean acceptability score (range: 5-20) <=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score >10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth.

  8. Mean Acceptability Score (Guardian)

    Time frame: Week 26

    Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable).

  9. Acceptability Percentage (Guardian)

    Time frame: Week 26

    Percentage of guardians with a mean acceptability score (range: 5-20) <=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score >10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian.

Secondary outcomes

  1. Change in Hemoglobin A1c Percentage

    Time frame: Baseline (Week 0) and Endline (Week 26)

    Change in point-of-care hemoglobin A1c (HbA1c) percentage.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Cincinnati

Registry information

Official study title

Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.