Type 1 Diabetes
Conditions
Keywords
Diabetes Mellitus, Type 1, Feeding Behavior, Glycemic Control
Brief summary
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
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.
Interventions
BEHAVIORALMyPlan - 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Cincinnati
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Percentage (Guardian) | 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. |
| Percent Time in Range (Baseline) | 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. |
| Percent Time in Range (Week 22-24) | 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. |
| Adherence to Each Eating Behavior Goal | 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; |
| Adherence to 0-5 Eating Behavior Goals | 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 |
| Mean Adherence to Overall Eating Behavior Pattern | 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; |
| Mean Acceptability Score (Youth) | 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). |
| Acceptability Percentage (Youth) | 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. |
| Mean Acceptability Score (Guardian) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c Percentage | Baseline (Week 0) and Endline (Week 26) | Change in point-of-care hemoglobin A1c (HbA1c) percentage. |
Countries
United States
Participant flow
Pre-assignment details
Fifty-two guardians and youth were enrolled as dyads. A total of 44 dyads were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | MyPlan - Individualized Eating Pattern |
|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Non-Hispanic Black | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 30 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Acceptability Percentage (Guardian) | 93.2 percentage of guardians |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Acceptability Percentage (Youth) | 86.4 percentage of participants |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 0 Goals Weekday | 0.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 1 Goal Weekday | 0.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 2 Goals Weekday | 7.5 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 3 Goals Weekday | 25.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 4 Goals Weekday | 50.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 5 Goals Weekday | 17.5 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 0 Goals Weekend | 0.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 1 Goal Weekend | 0.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 2 Goals Weekend | 7.9 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 3 Goals Weekend | 21.1 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 4 Goals Weekend | 58.9 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to 0-5 Eating Behavior Goals | Adherent to 5 Goals Weekend | 13.2 percentage of participants |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 1 Weekday | 92.5 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 2 Weekday | 30.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 3 Weekday | 87.5 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 4 Weekday | 75.0 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 5 Weekday | 92.5 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 1 Weekend | 81.6 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 2 Weekend | 36.8 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 3 Weekend | 86.8 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 4 Weekend | 76.3 percentage of participants |
| MyPlan - Individualized Planned Eating Pattern | Adherence to Each Eating Behavior Goal | Goal 5 Weekend | 94.7 percentage of participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Mean Acceptability Score (Guardian) | 7.8 score on a scale | Standard Deviation 2.3 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Mean Acceptability Score (Youth) | 7.8 score on a scale | Standard Deviation 2.4 |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Mean Adherence to Overall Eating Behavior Pattern | Number of Goals - Weekday | 3.8 goals | Standard Deviation 0.83 |
| MyPlan - Individualized Planned Eating Pattern | Mean Adherence to Overall Eating Behavior Pattern | Number of Goals - Weekend | 4.0 goals | Standard Deviation 0.8 |
Primary
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)
Population: Data from study-provided continuous glucose monitors was not available for 10 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Percent Time in Range (Baseline) | 40.6 percentage of CGM wear time | Standard Deviation 3.1 |
p-value: 0.7t-test, 2 sided
Primary
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
Population: Data from study-provided continuous glucose monitors was not available for 7 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Percent Time in Range (Week 22-24) | 41.7 percentage of CGM wear time | Standard Deviation 2.4 |
p-value: 0.7t-test, 2 sided
Secondary
Change in Hemoglobin A1c Percentage
Change in point-of-care hemoglobin A1c (HbA1c) percentage.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyPlan - Individualized Planned Eating Pattern | Change in Hemoglobin A1c Percentage | -0.32 percentage of red blood cells | Standard Deviation 0.89 |
p-value: 0.03t-test, 2 sided