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Childhood Obesity Treatment: A Maintenance Approach

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Skills Maintenance
Social Facilitation Maintenance
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Childhood obesity, intervention, obesity, weight loss, behavior therapy, peer group, social support network, child, clinical research, human subject

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child: 20%-100% overweight 7-12 years old At least one parent: At least 20% overweight Actively participates in program along with participating child Both participating family members: Can read and speak English at a 3rd grade level Exclusion Criteria: Either participating child or parent: has current psychopathology and is not in ongoing psychiatric care has an active substance abuse problem is not taking weight-affecting medications does not have a medical condition for which a weight loss program would be contraindicated does not have a physical disability of illness that limits their ability to do physical activity does not have major dietary restrictions is not participating in an active weight loss treatment All family members: do not have an active eating disorder

Sites / Locations

  • Washington University School of Medicine

Outcomes

Primary Outcome Measures

Weight (child and parent)

Secondary Outcome Measures

Weight related behaviors
Psychological functioning (specific and general)

Full Information

First Posted
March 8, 2006
Last Updated
March 8, 2006
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00301197
Brief Title
Childhood Obesity Treatment: A Maintenance Approach
Official Title
Childhood Obesity Treatment: A Maintenance Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
Obesity is a major public health problem. At least 15 million American adults are obese, and the number is rising. Childhood obesity is also increasing in prevalence and currently affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated with serious negative physical, emotional, and social consequences. Obese children are at high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children. The risk of an obese child becoming an obese adult is especially high when at least one parent is obese. To date, adult obesity is known to be resistant to treatment. In contrast, promising long-term effects have been found with children who received behavioral family-based weight loss treatment. However, even with state-of-the-science programs, a substantial percentage of children (i.e., over 40 percent) regain all or most of the weight lost once treatment ends. The proposed study examined the efficacy of two intervention strategies designed to improve the long-term maintenance of weight loss in children relative to discontinued treatment contact following an active weight loss treatment phase (no maintenance treatment control (NTC).
Detailed Description
This is an efficacy study comparing two intervention strategies designed to improve the long-term maintenance of weight loss in children compared to a no maintenance treatment control group. In this study, overweight children between the ages of 7-12 years old participated along with their overweight parents in a 20-week behavioral, family-based weight loss treatment. Following weight loss treatment, participants were randomly assigned to one of two 4-month maintenance interventions or to a no-continued treatment control. The Behavioral Skills Maintenance intervention (BSM) will confront the declining motivation to engage in weight-maintenance behaviors, incorporate specific skills for weight maintenance, and teach coping skills and relapse prevention techniques. The Social Facilitation Maintenance treatment will use an innovative, socially-based approach to enhance peer support, increase parental instrumental support, improve body image, and teach effective responses to teasing as methods for sustaining weight maintenance behaviors (i.e., healthy diet and physical activity). It is expected that children participating in BSM and SFM interventions will demonstrate better outcomes at the point of the weight maintenance intervention cessation than children not provided any maintenance treatment. It is further hypothesized that the developmentally appropriate focus and more pervasive and sustaining nature of the SFM treatment targets relative to BSM targets will result in better weight maintenance outcomes for SFM than BSM children. Follow-up assessments will occur at the end of the maintenance phase of treatment, as well as at 12 and 24 months following the initial weight loss treatment. Effective maintenance treatments in children will have a substantial impact on children's immediate and future physical, psychological, and social well being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Childhood obesity, intervention, obesity, weight loss, behavior therapy, peer group, social support network, child, clinical research, human subject

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Behavioral Skills Maintenance
Intervention Type
Behavioral
Intervention Name(s)
Social Facilitation Maintenance
Primary Outcome Measure Information:
Title
Weight (child and parent)
Secondary Outcome Measure Information:
Title
Weight related behaviors
Title
Psychological functioning (specific and general)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child: 20%-100% overweight 7-12 years old At least one parent: At least 20% overweight Actively participates in program along with participating child Both participating family members: Can read and speak English at a 3rd grade level Exclusion Criteria: Either participating child or parent: has current psychopathology and is not in ongoing psychiatric care has an active substance abuse problem is not taking weight-affecting medications does not have a medical condition for which a weight loss program would be contraindicated does not have a physical disability of illness that limits their ability to do physical activity does not have major dietary restrictions is not participating in an active weight loss treatment All family members: do not have an active eating disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise E Wilfley, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17925518
Citation
Wilfley DE, Stein RI, Saelens BE, Mockus DS, Matt GE, Hayden-Wade HA, Welch RR, Schechtman KB, Thompson PA, Epstein LH. Efficacy of maintenance treatment approaches for childhood overweight: a randomized controlled trial. JAMA. 2007 Oct 10;298(14):1661-73. doi: 10.1001/jama.298.14.1661.
Results Reference
derived

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Childhood Obesity Treatment: A Maintenance Approach

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