Behavioral Treatment for Obese Preschoolers (LAUNCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01546727
First received: March 2, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Obesity
Behavioral: Behavioral Family Intervention
Behavioral: Motivational Interviewing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change in BMIz score [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Body Mass Index z-score


Secondary Outcome Measures:
  • Change in BMI z at follow up [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
  • Change in Caloric Intake [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Three 24 hour dietary recalls at each time point

  • Change in Physical Activity [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Physical Activity will be measured using Accelermeters set in 15 sec epochs

  • Change in home health environment [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Home observation recording of food (e.g.,fruits, vegetables, high calorie foods and beverages)and presence of TV in child's bedroom

  • Changes in parent calorie intake [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Will assess using Block 2005 Food Frequency

  • Changes in parent physical activity [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Will be assessed using the Paffenbarger Activity Questionnaire for calorie expenditure

  • Parenting and Child Eating Behaviors [ Time Frame: Baseline, 6 month, 12 months, 18 months ] [ Designated as safety issue: No ]
    Will assess using Parenting Styles and Dimensions, About Your Child's Eating - Revised, and Child Feeding Questionnaire

  • Change in Health Related Quality of Life [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Will be assessed using the PedQL


Estimated Enrollment: 168
Study Start Date: March 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Behavioral Treatment
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: Behavioral Family Intervention
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 Name: LAUNCH
Active Comparator: Motivational Interviewing
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.
Behavioral: Motivational Interviewing
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 Name: MI
No Intervention: Standard of Care
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

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).

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546727

Contacts
Contact: Cindy Zion, BS 513-636-3931 Cynthia.Zion@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Cindy Zion, BS         
Principal Investigator: Lori J Stark, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Lori J Stark, Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01546727     History of Changes
Other Study ID Numbers: R01DK091251, 1R01DK091251-01A1
Study First Received: March 2, 2012
Last Updated: August 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Preschoolers
Obesity
Behavioral Treatment

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014