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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Percent Time in Range (Baseline)
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.
Time frame: Baseline (Week 0-2)
Percent Time in Range (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.
Time frame: Week 22-24
Adherence to Each Eating Behavior Goal
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;
Time frame: Between Week 22 and Week 24
Adherence to 0-5 Eating Behavior Goals
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
Time frame: Between Week 22 and Week 24
Mean Adherence to Overall Eating Behavior Pattern
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;
Time frame: Between Week 22 and Week 24
Mean Acceptability Score (Youth)
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).
Time frame: Week 26
Acceptability Percentage (Youth)
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.
Time frame: Week 26
Mean Acceptability Score (Guardian)
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).
Time frame: Week 26
Acceptability Percentage (Guardian)
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.
Time frame: Week 26
Change in Hemoglobin A1c Percentage
Change in point-of-care hemoglobin A1c (HbA1c) percentage.
Time frame: Baseline (Week 0) and Endline (Week 26)
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