Trial Outcomes & Findings for "MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes (NCT NCT05147324)
NCT ID: NCT05147324
Last Updated: 2024-04-23
Results Overview
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.
COMPLETED
NA
52 participants
Baseline (Week 0-2)
2024-04-23
Participant Flow
Fifty-two guardians and youth were enrolled as dyads. A total of 44 dyads were included in the analysis.
Participant milestones
| Measure |
"MyPlan" - Individualized Eating Pattern
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.
"MyPlan" - Individualized Eating Pattern: 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.
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Overall Study
STARTED
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52
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Overall Study
COMPLETED
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44
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
"MyPlan" - Individualized Eating Pattern
n=44 Participants
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.
"MyPlan" - Individualized Eating Pattern: 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.
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Age, Continuous
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14.7 years
STANDARD_DEVIATION 1.6 • n=99 Participants
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Sex: Female, Male
Female
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26 Participants
n=99 Participants
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Sex: Female, Male
Male
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18 Participants
n=99 Participants
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Race/Ethnicity, Customized
Non-Hispanic White
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30 Participants
n=99 Participants
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Race/Ethnicity, Customized
Non-Hispanic Black
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9 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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5 Participants
n=99 Participants
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Region of Enrollment
United States
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44 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline (Week 0-2)Population: Data from study-provided continuous glucose monitors was not available for 10 participants.
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.
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=34 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Percent Time in Range (Baseline)
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40.6 percentage of CGM wear time
Standard Deviation 3.1
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PRIMARY outcome
Timeframe: Week 22-24Population: Data from study-provided continuous glucose monitors was not available for 7 participants.
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.
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=37 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Percent Time in Range (Week 22-24)
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41.7 percentage of CGM wear time
Standard Deviation 2.4
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PRIMARY outcome
Timeframe: Between Week 22 and Week 24Population: Data are reported for a total of 41 unique participants between weekday and weekend 24-hour dietary recall. Neither a weekday nor weekend day 24-hour dietary recall was completed for 3 participants. Of the 41 participants, one did not complete a weekday 24-hour dietary recall and 3 participants did not complete a weekend 24-hour dietary recall.
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;
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=41 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Adherence to Each Eating Behavior Goal
Goal 1 Weekday
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92.5 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 2 Weekday
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30.0 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 3 Weekday
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87.5 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 4 Weekday
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75.0 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 5 Weekday
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92.5 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 1 Weekend
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81.6 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 2 Weekend
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36.8 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 3 Weekend
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86.8 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 4 Weekend
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76.3 percentage of participants
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Adherence to Each Eating Behavior Goal
Goal 5 Weekend
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94.7 percentage of participants
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PRIMARY outcome
Timeframe: Between Week 22 and Week 24Population: Data are reported for a total of 41 unique participants between weekday and weekend 24-hour dietary recall. Neither a weekday nor weekend day 24-hour dietary recall was completed for 3 participants. Of the 41 participants, one did not complete a weekday 24-hour dietary recall and 3 participants did not complete a weekend 24-hour dietary recall.
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
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=41 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Adherence to 0-5 Eating Behavior Goals
Adherent to 0 Goals Weekday
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0.0 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 1 Goal Weekday
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0.0 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 2 Goals Weekday
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7.5 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 3 Goals Weekday
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25.0 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 4 Goals Weekday
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50.0 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 5 Goals Weekday
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17.5 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 0 Goals Weekend
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0.0 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 1 Goal Weekend
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0.0 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 2 Goals Weekend
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7.9 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 3 Goals Weekend
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21.1 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 4 Goals Weekend
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58.9 percentage of participants
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Adherence to 0-5 Eating Behavior Goals
Adherent to 5 Goals Weekend
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13.2 percentage of participants
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PRIMARY outcome
Timeframe: Between Week 22 and Week 24Population: Data are reported for a total of 41 unique participants between weekday and weekend 24-hour dietary recall. Neither a weekday nor weekend day 24-hour dietary recall was completed for 3 participants. Of the 41 participants, one did not complete a weekday 24-hour dietary recall and 3 participants did not complete a weekend 24-hour dietary recall.
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;
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=41 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Mean Adherence to Overall Eating Behavior Pattern
Number of Goals - Weekday
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3.8 goals
Standard Deviation 0.83
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Mean Adherence to Overall Eating Behavior Pattern
Number of Goals - Weekend
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4.0 goals
Standard Deviation 0.80
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PRIMARY outcome
Timeframe: Week 26Mean 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).
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=44 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Mean Acceptability Score (Youth)
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7.8 score on a scale
Standard Deviation 2.4
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PRIMARY outcome
Timeframe: Week 26Percentage 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.
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=44 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Acceptability Percentage (Youth)
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86.4 percentage of participants
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PRIMARY outcome
Timeframe: Week 26Mean 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).
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=44 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Mean Acceptability Score (Guardian)
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7.8 score on a scale
Standard Deviation 2.3
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PRIMARY outcome
Timeframe: Week 26Percentage 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.
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=44 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Acceptability Percentage (Guardian)
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93.2 percentage of guardians
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SECONDARY outcome
Timeframe: Baseline (Week 0) and Endline (Week 26)Population: HbA1c was not completed for the endline visit at Week 26 for 3 participants who completed this visit remotely.
Change in point-of-care hemoglobin A1c (HbA1c) percentage.
Outcome measures
| Measure |
"MyPlan" - Individualized Planned Eating Pattern
n=41 Participants
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.
"MyPlan" - Individualized Planned Eating Pattern: 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.
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Change in Hemoglobin A1c Percentage
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-0.32 percentage of red blood cells
Standard Deviation 0.89
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Adverse Events
"MyPlan" - Individualized Eating Pattern
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Angelica Cristello Sarteau
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place