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Childhood Obesity Treatment: A Maintenance Approach

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ClinicalTrials.gov Identifier: NCT00301197
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : March 10, 2006
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description
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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).

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Behavioral Skills Maintenance Behavioral: Social Facilitation Maintenance Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Childhood Obesity Treatment: A Maintenance Approach
Study Start Date : August 1999
Study Completion Date : April 2004
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Weight (child and parent)

Secondary Outcome Measures :
  1. Weight related behaviors
  2. Psychological functioning (specific and general)

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301197


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Denise E Wilfley, PhD Washington University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00301197    
Other Study ID Numbers: 5R01HD036904 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: March 10, 2006
Last Verified: March 2006
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Childhood obesity
intervention
obesity
weight loss
behavior therapy
 peer group
social support network
child
clinical research
human subject
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight