Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259324
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2005-11-28
Brief Title:
Childhood Obesity Treatment Targeting Specific Behaviors
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Childhood Obesity Treatment Targeting Specific Behaviors
Status:
COMPLETED
Status Verified Date:
2007-12
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 US is in the midst of an obesity epidemic affecting young children The pediatric primary care setting is an ideal place to address this problem since most families have frequent contact with their pediatrician and a childs health status is regularly assessed in this setting Recommendations for treating children with a body mass index BMI over the 85th percentile in the primary care setting have been developed by an Expert Committee on childhood Programs are needed that meet the recommendations from the Committee which include 1 beginning treatment as young as possible 2 focusing on the family with the parent being the primary change agent for treatment 3 using behavior modification techniques to change eating and activity behaviors and 4 making 2 or 3 very specific changes in diet and activity at one time Thus the aim of this R21 application is to develop implement and evaluate a 6-month behavioral childhood obesity intervention that meets the Committees recommendations and can be implemented in a primary care setting A second aim of this project is to determine which eating and activity behaviors should be targeted in the intervention One hundred thirty-five children aged 4 to 9 years with a BMI 85th percentile assessed and referred by their pediatricians will be randomized to one of three conditions 1 a newsletter condition 2 a Behavioral Parenting Program that increases physical activity 60 minday and decreases sweetened drink consumption 3 servingsweek Traditional or 3 a Behavioral Parenting Program that reduces TV watching 2 hoursday and increases low-fat milk consumption 2 servingsday Substitutes Follow-up assessments on weight height and standardized BMI z-BMI the primary dependent variable will be conducted at 3 6 9 and 12 months Pediatricians will provide follow-up letters to families regarding weight and height status following the assessments This pilot study allows us to determine the feasibility and efficacy of a pediatric obesity intervention that optimizes the role of the pediatrician and meets the Committees recommendations for treatment in a primary care setting Moreover by comparing the effects of targeting the traditional or substitute behaviors data will be obtained for a power analysis for a full-scale trial of the effects of these two approaches on long-term weight loss
Detailed Description:
None
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