"MyPlan" - Individualized Eating Patterns for Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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 plan
      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 plan 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.
    

Intervention name(s): "MyPlan" - Individualized Eating Pattern
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): "MyPlan"
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Feeding Behavior; Glycemic Control