Healthy Eating, Physical Activity, and Glycemic Control in Young Children With T1D
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The incidence of type 1 diabetes (T1D) in young children (age <5 years) is rising. The burden
      of responsibility for disease management rests on parents and caregivers to check blood
      sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic
      control. This occurs at a vulnerable time in life when children's behavior is unpredictable,
      their T1D is difficult to control, and parenting stress is elevated. Despite behavioral
      interventions that have demonstrated success in reducing rates of parent stress and improving
      child behavior, improvements in young children's glycemic control has not been sufficiently
      achieved. The investigators' research will attempt to achieve this goal through the
      development and pilot of an innovative behavioral intervention for T1D in parents of young
      children. The focus of the intervention is on improving young children's nutrition and
      physical activity through the use of parent consultants and delivery of intervention through
      phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary
      caregivers of young children (<5 years) diagnosed with T1D for at least 6 months will receive
      the intervention and then be assessed at 3- and 6- months post baseline on indices of
      behavior and glycemic control (including continuous glucose monitoring). Participants will
      also complete in-depth surveys to provide qualitative as well as quantitative data. At the
      end of Phase 1, the data will be analyzed and used to develop the intervention further for
      Phase 2. During Phase 2, 60 participants and their children will be randomized to either the
      revised intervention (treatment) or usual care (control) condition. Intervention components
      include: T1D management support delivered by trained lay parent consultants, and T1D
      parenting strategies specific to improving eating and physical activity behaviors delivered
      by bachelor's level behavioral assistants via telephone and text messaging. Biomedical and
      psychosocial measurements (including HbA1c, physical activity, nutrition, mealtime behavior,
      parenting stress, quality of life) will occur at baseline and 3- and 6-months post baseline.
      The results of this work will ultimately lead to a program which can improve young children's
      T1D management and glycemic control that can be translated into a variety of clinical
      practice settings.
    

Detailed description: 
      Young children (<5 years) comprise a growing number of persons diagnosed with type 1 diabetes
      (T1D)--a costly, chronic illness [1, 2]. Early age at diagnosis and poor glycemic control
      during these early years increases risk for development of serious diabetes-related
      complications (ref). Thus, these years represent a critical period for establishing proper
      patterns of T1D management and glycemic control in young children [7]. In addition to young
      children's daily reliance on parents for T1D care, such as blood glucose (BG) monitoring and
      insulin administration, careful attention must be paid to diet and physical activity
      regulation. Behavioral interventions supporting and enhancing T1D management among parents of
      these young children have the potential for significant impact on children's glycemic control
      as well as developmentally important outcomes, and may reduce both immediate and long-term
      clinical and public health burdens of T1D complications.

      Although multicomponent behavioral interventions for parents of young children with T1D
      demonstrate potentially promising psychosocial outcomes [8-10], concomitant improvements in
      children's glycemic control from these interventions remain elusive. Two critical areas not
      yet addressed directly in interventions is the promotion of healthy eating and engagement in
      consistent physical activity in young children, nor the behavioral strategies to support
      parents in these challenges that occur multiple times daily (e.g., each meal/snack, each
      physical activity experience). The current proposal utilizes the extensive expertise of our
      multidisciplinary team to refine and pilot an innovative and translatable intervention
      targeting eating and physical activity behaviors directly associated with glycemic control in
      young children that can ultimately be adopted outside of research settings. The
      investigators' prior successful clinical research efforts engaging parents of young children
      with T1D in behavioral interventions (R01 DK080102) places them in a unique position to
      further design and pilot this intervention and ultimately be well poised to run a future
      full-scale efficacy trial.

      The current proposal shifts the investigators' prior interventions' focus away from parental
      stress and instead highlights behavioral strategies promoting healthy eating and engagement
      in consistent physical activity, as well as nutrition and physical activity links to glycemic
      control. Based upon positive preliminary data the investigators will utilize novel assessment
      (accelerometry, personal activity monitors (PAM), and continuous glucose monitors (CGM)) and
      intervention components (parent consultants and trained intervention telephone counselors),
      with the intervention being delivered via telephone and in-person. The investigators will
      follow an iterative mixed methods approach to refine the intervention from Phase 1 to Phase
      2. During phase 1 the investigators will pre-pilot the intervention by examining feasibility
      and acceptability in 10 parents (of children ages 1-5 yrs with a minimum of 1 yr duration of
      diabetes). The investigators will use qualitative interviews, questionnaire, and objective
      (CGM, accelerometry) data to help refine key intervention components and discern best areas
      for intervention target (i.e., low glycemic breakfast or different meal; planned physical
      activity or increasing steps through daily living; PAM or accelerometry). This phase will
      include soliciting feedback from the advisory board leading to further refinement of the
      intervention and manual of procedures. During phase 2 the investigators will execute a pilot
      randomized trial evaluating whether glycemic control and developmentally-important outcomes
      (child feeding and physical activity) in young children with T1D can be favorably impacted.
      Phase 2 will include 60 parents (of children ages 1-5 yrs) randomly allocated to either the
      intervention (n=30) or standard care (n=30). Assessments will be completed 3 times (T1,
      T2-immediately post intervention, and T3-6 months post-intervention). Clinical, biological,
      and behavioral diabetes outcomes will be measured. Specific Aims for this trial are:

      Aim 1. Pilot test and refine innovative and feasible assessment and intervention components
      for T1D control in young children, and examine acceptability and impact in parents of young
      children. At the conclusion of Phase 1, this Aim results in an innovative intervention
      program, supported by state of the art assessment tools and preliminary data. The
      investigators hypothesize that the intervention will be associated with high feasibility and
      acceptability, improved T1D management, and reduction of behavioral challenges related to
      eating and physical activity.

      Aim 2. Determine the intervention's efficacy for improving young children's glycemic control
      and parent's management of eating and physical activity behaviors. The investigators
      hypothesize that the Phase 2 pilot will demonstrate that relative to usual care, the
      intervention will evidence 1) Significantly better glycemic control (i.e., HbA1c <8.5% and
      higher percentage of BG levels in the 100-200 mg/dl range, per ADA recommendations) and 2)
      Significantly fewer child feeding and activity behavior problems (e.g., food refusal,
      dawdling at mealtimes, physical inactivity). 3. Mediating effects of eating and physical
      activity on glycemic control will also be explored.

      Aim 3. Explore the feasibility of program implementation in a larger scale efficacy trial,
      and in clinical T1D management. Using a purposeful sample subset of parents in the
      intervention condition, the investigators will use qualitative interviews to further examine
      the impact of the intervention, and assist in further refinement prior to a larger scale
      trial. The investigators will also interview advisory board members including members of the
      health care team to gather system- and provider-level data about key capacities to inform the
      integration of our intervention into patient/work flow in anticipation of a larger efficacy
      trial.
    

Intervention name(s): Type One Training (TOT)
Intervention type(s): Behavioral
Intervention description(s): The intervention is comprised of a number of modes of delivery including in person, use of parent peer consultant, telephone intervention, and text messaging. The intervention is based on Social Cognitive Theory and previous work of the investigators.The focus of the intervention is on working with parents to improve child eating and physical activity behaviors as a means of improving glycemic control in very young children with type 1 diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other