Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301197
Status:
COMPLETED
Last Update Posted:
2006-03-10
First Post:
2006-03-08
Brief Title:
Childhood Obesity Treatment A Maintenance Approach
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Childhood Obesity Treatment A Maintenance Approach
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie 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 childrens immediate and future physical psychological and social well being
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None