MyPlan - Individualized Eating Patterns for Adolescents With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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 plan 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 plan 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.

Official Title
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Individualized Eating Patterns to Improve Glycemic Control in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: MyPlan - Individualized Eating Pattern


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyPlan - Individualized Eating Pattern<br>All youth enrolled in the study will receive the 6-month MyPlan behavioral intervention. Youth will be paired with a dietitian to individualize the eating plan and receive support in setting and refining action plans focused on adhering to the five eating behavior goals that define the eating plan. | Behavioral: MyPlan - Individualized Eating Pattern<br>* 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 plan 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 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 eating plan at three months is based on weight status, adherence according to logs, and youth/guardian acceptability.<br>* Other names: MyPlan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent time in range | Change in percentage of time spent in the glycemic range of 70-180 mg/dL between 22-24 week and 0-2 week blinded continuous glucose monitor (CGM) wear time. | Baseline (Week 0) and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean adherence to each of the personalized eating behavior goals | Two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during 22-24 weeks of blinded CGM wear time will be used to assess average continuous percent deviation from each personalized eating behavior goal: 3-4 meals (>15% CHO) and 1-2 snacks consumed; Spacing of meals/snacks (e.g., >2 hours and <4 hours apart); Personalized carbohydrate gram target ranges at each meal and snack; No snacking after dinner; Snack/meal consumed within 1-2 hours of waking; | Week 24 | 
| Mean adherence to personalized eating behavior pattern | The average of the average percent deviations from each personalized eating behavior goal for an overall measure of adherence to the eating behavior pattern, as assessed via two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during 22-24 weeks of blinded CGM wear time: 3-4 meals (>15% CHO) and 1-2 snacks consumed; Spacing of meals/snacks (e.g., >2 hours and <4 hours apart); Personalized carbohydrate gram target ranges at each meal and snack; No snacking after dinner; Snack/meal consumed within 1-2 hours of waking; | Week 24 | 
| Percentage of time participant adhered to each personalized eating behavior goal | Two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during 22-24 weeks blinded CGM wear time will be used to assess the percentage of time participants followed each of the personalized eating behavior goals: 3-4 meals (>15% CHO) and 1-2 snacks consumed; Spacing of meals/snacks (e.g., >2 hours and <4 hours apart); Personalized carbohydrate gram target ranges at each meal and snack; No snacking after dinner; Snack/meal consumed within 1-2 hours of waking; | Week 24 | 
| Mean number of personalized eating behavior goals adhered to by participants | Two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during the 22-24 weeks blinded CGM wear time will be used to assess the average number of personalized eating behavior goals (range: 0-5) adhered to by participants. | Week 24 | 
| Guardian composite acceptability score | Composite acceptability scores (range: 0-8) will be calculated from ordinal responses to 8 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. Acceptability assessment will be filled out at 26 weeks of the study. Higher composite acceptability scores indicate greater acceptability of the eating plan (0 - unacceptable to 8 - highly acceptable). | Week 26 | 
| Youth composite acceptability score | Composite acceptability scores (range: 0-8) will be calculated from ordinal responses to 8 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. Acceptability assessment will be filled out at 26 weeks of the study. Higher composite acceptability scores indicate greater acceptability of the eating plan (0 - unacceptable to 8 - highly acceptable). | Week 26 | 
| Change in hemoglobin A1c percentage | Change in point-of-care hemoglobin A1c (HbA1c) percentage. | Baseline (Week 0) and Endline (Week 26) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Feeding Behavior, Glycemic Control