Overview

This trial is active, not recruiting.

Condition obesity
Treatments behavioral family intervention, motivational interviewing
Phase phase 3
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date March 2012
End date December 2015
Trial size 168 participants
Trial identifier NCT01546727, 1R01DK091251-01A1, R01DK091251

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This intervention will provide nutritional counseling for a health diet, parent training in effective child behavioral management strategies, and stimulus control of the home environment delivered via group based clinic visits and individual home visits on alternate weeks
behavioral family intervention LAUNCH
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.
(Active Comparator)
This intervention will shared information with parents about their child's weight and use motivational interviewing to elicit changes parents would like to make to their child diet and activity patterns.
motivational interviewing MI
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.
(No Intervention)
Participants in this arm will be followed over time and be assessed on the primary and secondary outcomes at the same time points as the two treatment arms

Primary Outcomes

Measure
Change in BMIz score
time frame: Baseline to 6 months

Secondary Outcomes

Measure
Change in BMI z at follow up
time frame: Baseline, 6 months, 12 months, 18 months
Change in Caloric Intake
time frame: Baseline, 6 months, 12 months, 18 months
Change in Physical Activity
time frame: Baseline, 6 months, 12 months, 18 months
Change in home health environment
time frame: Baseline, 6 months, 12 months, 18 months
Changes in parent calorie intake
time frame: Baseline, 6 months, 12 months, 18 months
Changes in parent physical activity
time frame: Baseline, 6 months, 12 months, 18 months
Parenting and Child Eating Behaviors
time frame: Baseline, 6 month, 12 months, 18 months
Change in Health Related Quality of Life
time frame: Baseline, 6 months, 12 months, 18 months

Eligibility Criteria

Male or female participants from 2 years up to 5 years old.

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

Additional Information

Official title Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers
Principal investigator Lori J Stark, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.