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

NCT05147324 | Completed Results DMC

• 2 other identifiers: 21-13371R21DK125033-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Keywords

Diabetes Mellitus, Type 1; Feeding Behavior; Glycemic Control

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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;

  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

  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;

  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).

  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.

  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).

  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.

  Week 26

Secondary Outcomes (1)

• Change in Hemoglobin A1c Percentage

  Baseline (Week 0) and Endline (Week 26)

Study Arms (1)

"MyPlan" - Individualized Planned Eating Pattern

EXPERIMENTAL

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.

Behavioral: "MyPlan" - Individualized Planned Eating Pattern

Interventions

"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.

Also known as: "MyPlan"

"MyPlan" - Individualized Planned Eating Pattern

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Cincinnati: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0394, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding Behavior

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Angelica Cristello Sarteau
• Organization: University of North Carolina at Chapel Hill

angcri@live.unc.edu

919-445-1191

Study Officials

• Elizabeth J Mayer-Davis, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Sarah Couch, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 7, 2021
• Study Start: December 13, 2021
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 36 months following publication. No end date.
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (2)