Behavioral Treatment for Obese Preschoolers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic
      and home family behavioral intervention (LAUNCH) against 1) motivational interviewing
      (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168
      children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body mass
      index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI)
      or standard of care. The primary end-point will be change in BMI z-score at the end of
      treatment. The investigators will also assess maintenance of treatment gains at 6 and 12
      months after treatment, and changes in factors thought to be mechanisms for change in weight
      (food intake and activity level), changes in the obesiogenic environment (parent weight, food
      intake and activity, and changes in the home food environment) and factors that could be
      negatively impacted (parent and child eating and feeding interactions).
    

Detailed description: 
      Obesity now affects an estimated 2.8 million children between the ages of 2 and 5 years, as
      the prevalence of obesity among preschool school age children has almost tripled from 5% of
      the population in 1971-1980 to 13.9% by 2004. Being obese at age 5 confers a 47 times greater
      risk of being overweight or obese at age 12. In fact being obese any time between 2 and 5
      year increases the risk of remaining overweight or obese as an adult by four times the risk
      of nonobese preschoolers. Being obese as a preschooler also increases the risk of a number of
      serious health conditions, including a 2.6 times greater risk of developing type 2 diabetes
      by age 21 years. In fact, the obesity rate among preschoolers is thought to impose such a
      cumulative health risk across the life span that children born today, for the first time in
      history, are expected to have a shorter life expectancy than their parents by to 2 to 5
      years. Early effective treatments for establish obesity during the preschool years have the
      potential to change the trajectory of obesity and related co-morbid health condition across
      the life-span by reducing obesity and changing the development of lifestyle habits of diet
      and exercise at a time when these are being formed. Yet research on interventions to reduce
      obesity in preschool children is severely limited and none exist that addresses established
      obesity in this age group. Therefore the current study has the potential to have a
      significant impact on public health by providing evidence-based treatment for obesity in
      preschoolers, a developmental period in which eating and activity patterns are being formed,
      that could significantly impact the trajectory of obesity thereby decreasing the population
      obesity rates and associated healthcare costs at across the life span. Fortunately,
      investigators are on their way to addressing the problem of obesity reduction in already
      obese preschoolers. The investigators have developed and conducted a pilot randomized
      clinical trial of a treatment program aimed at reducing obesity in already obese preschool
      children. The program (Learning about Activity and Understanding Nutrition for Child Health:
      LAUNCH) is tailored to the developmental stage of preschool children and produced promising
      preliminary results. In the proposed trial a 3 arm, randomized, parallel group design will
      test LAUNCH against 1) motivational interviewing (attention control; MI) and 2) standard of
      care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the
      criteria for obesity (>95th percentile for body mass index; BMI). Participants will be
      randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary
      end-point will be change in BMI z-score at the end of treatment. The investigators will also
      assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in
      factors thought to be mechanisms for change in weight (food intake and activity level),
      changes in the obesiogenic environment (parent weight, food intake and activity, and changes
      in the home food environment) and factors that could be negatively impacted (parent and child
      eating and feeding interactions).
    

Intervention name(s): Behavioral Family Intervention; Motivational Interviewing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three months of weekly treatment delivered via alternating group based clinic visits and individual home visits followed by three months of every other week treatment alternating between clinic and home.; Motivational interviewing will be delivered at the same frequency at the behavioral intervention with 4 in-person visits spaced at the first visit, month 3 and month 5. Phone calls will be conducted weekly during the first 3 months and every other week during months 4 through 6.
Other intervention name(s): LAUNCH; MI
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preschoolers; Obesity; Behavioral Treatment