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Completed

NCT Number: NCT01546727

Behavioral Treatment for Obese Preschoolers

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).

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children ages 2 years 0 months to 5 years 11 months
  • BMI percentile at or above the 95th percentile for age- and gender, but no more than 100% above the median BMI for age and gender.
  • English-speaking
  • Live within 50 miles of Cincinnati Children's Hospital Medical Center (CCHMC)
  • Medical clearance from the child's pediatrician to participate.

Exclusion criteria

  • Medical conditions known to promote obesity (e.g., Prader-Willi syndrome, Cushing's syndrome)
  • Already involved with another weight control program
  • Taking weight-affecting medications (e.g., steroids).
  • A disability or illness that would preclude them from engaging in at least moderate intensity physical activity
  • Developmental disability

Treatment and study plan

Behavioral Family Intervention

Behavioral

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.

Other names: LAUNCH

Motivational Interviewing

Behavioral

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 names: MI

Primary outcomes

  1. Change in BMIz score

    Time frame: Baseline to 6 months

    Body Mass Index z-score

Secondary outcomes

  1. Change in BMI z at follow up

    Time frame: Baseline, 6 months, 12 months, 18 months

  2. Change in Caloric Intake

    Time frame: Baseline, 6 months, 12 months, 18 months

    Three 24 hour dietary recalls at each time point

  3. Change in Physical Activity

    Time frame: Baseline, 6 months, 12 months, 18 months

    Physical Activity will be measured using Accelermeters set in 15 sec epochs

  4. Change in home health environment

    Time frame: Baseline, 6 months, 12 months, 18 months

    Home observation recording of food (e.g.,fruits, vegetables, high calorie foods and beverages)and presence of TV in child's bedroom

  5. Changes in parent calorie intake

    Time frame: Baseline, 6 months, 12 months, 18 months

    Will assess using Block 2005 Food Frequency

  6. Changes in parent physical activity

    Time frame: Baseline, 6 months, 12 months, 18 months

    Will be assessed using the Paffenbarger Activity Questionnaire for calorie expenditure

  7. Parenting and Child Eating Behaviors

    Time frame: Baseline, 6 month, 12 months, 18 months

    Will assess using Parenting Styles and Dimensions, About Your Child's Eating - Revised, and Child Feeding Questionnaire

  8. Change in Health Related Quality of Life

    Time frame: Baseline, 6 months, 12 months, 18 months

    Will be assessed using the PedQL

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers

Acronym: LAUNCH

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 7, 2012
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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