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| Tracking Information | |||||
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| First Received Date ICMJE | March 8, 2006 | ||||
| Last Updated Date | March 8, 2006 | ||||
| Start Date ICMJE | August 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Weight (child and parent) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Childhood Obesity Treatment: A Maintenance Approach | ||||
| Official Title ICMJE | Childhood Obesity Treatment: A Maintenance Approach | ||||
| 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). |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 216 | ||||
| Completion Date | April 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Child:
At least one parent:
Both participating family members:
Exclusion Criteria: Either participating child or parent:
All family members:
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| Gender | Both | ||||
| Ages | 7 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00301197 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 5R01HD036904 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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