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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00301197 |
Purpose
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 | Intervention |
|---|---|
|
Obesity |
Behavioral: Behavioral Skills Maintenance Behavioral: Social Facilitation Maintenance |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Childhood Obesity Treatment: A Maintenance Approach |
| Estimated Enrollment: | 216 |
| Study Start Date: | August 1999 |
| Estimated Study Completion Date: | April 2004 |
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.
Eligibility| Ages Eligible for Study: | 7 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Child:
At least one parent:
Both participating family members:
Exclusion Criteria:
Either participating child or parent:
All family members:
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Denise E Wilfley, PhD | Washington University School of Medicine |
More Information
| Study ID Numbers: | 5R01HD036904 |
| Study First Received: | March 8, 2006 |
| Last Updated: | March 8, 2006 |
| ClinicalTrials.gov Identifier: | NCT00301197 |
| Health Authority: | United States: Federal Government |
|
Childhood obesity intervention obesity weight loss behavior therapy |
peer group social support network child clinical research human subject |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition |
