Clinical trial NCT05147324: "MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes
Official title: Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Diabetes Mellitus, Type 1
Feeding Behavior
Glycemic Control
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Cincinnati
First posted: 2021-12-07
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Time in Range (Baseline)
timeFrame: Baseline (Week 0-2)
measure: Percent Time in Range (Week 22-24)
timeFrame: Week 22-24
measure: Adherence to Each Eating Behavior Goal
timeFrame: Between Week 22 and Week 24
measure: Adherence to 0-5 Eating Behavior Goals
timeFrame: Between Week 22 and Week 24
measure: Mean Adherence to Overall Eating Behavior Pattern
timeFrame: Between Week 22 and Week 24
measure: Mean Acceptability Score (Youth)
timeFrame: Week 26
measure: Acceptability Percentage (Youth)
timeFrame: Week 26
measure: Mean Acceptability Score (Guardian)
timeFrame: Week 26
measure: Acceptability Percentage (Guardian)
timeFrame: Week 26
Secondary outcomes:
measure: Change in Hemoglobin A1c Percentage
timeFrame: Baseline (Week 0) and Endline (Week 26)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Elizabeth J Mayer-Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Sarah Couch, PhD
role: PRINCIPAL_INVESTIGATOR
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