Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177229
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2005-09-12
Brief Title:
KidQuest Family-Based Weight Control
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Family-Based Treatment of Severe Pediatric Obesity
Status:
COMPLETED
Status Verified Date:
2008-02
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:
The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12 and to compare this approach to standard medical management of severe pediatric obesity
Detailed Description:
The prevalence of pediatric obesity has increased significantly and approximately 11 of American children and adolescents are obese Of particular concern the greatest increase in prevalence has occured among the heaviest children Severe pediatric obesity defined as 150 of ideal body weight for height is associated with higher rates of medical and psychosocial morbidity than milder obesity is Moreover severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established few studies have focused on the treatment of severe obesity Thus in this application we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity
Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups We hypothesized that 1 Children who participate in the family-based program when compared to children who receive usual care will show favorable changes in body mass index body composition food intake activity level and cardiovascular risk factors 2 Children who participate in the family-based program when compared to children who receive usual care will report higher levels of self-esteem social competence and health-related quality of life and report fewer psychiatric symptoms A secondary aim of the the proposed investigation is to examine the relationships among gender race compliance to diet and exercise level of parent adherence and treatment outcome The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population
Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups We hypothesized that 1 Children who participate in the family-based program when compared to children who receive usual care will show favorable changes in body mass index body composition food intake activity level and cardiovascular risk factors 2 Children who participate in the family-based program when compared to children who receive usual care will report higher levels of self-esteem social competence and health-related quality of life and report fewer psychiatric symptoms A secondary aim of the the proposed investigation is to examine the relationships among gender race compliance to diet and exercise level of parent adherence and treatment outcome The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population
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