Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215111
Status:
COMPLETED
Last Update Posted:
2015-02-05
First Post:
2005-09-15
Brief Title:
Role of Carbohydrate Modification in Weight Management Among Obese Children
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Role of Carbohydrate Modification in Weight Management Among Obese Children
Status:
COMPLETED
Status Verified Date:
2015-02
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 test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12 In addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children
Detailed Description:
The treatment of pediatric obesity supported by the medical community is a moderate restriction in calories by modifying intake of fat and simple sugars along with an increase in energy expenditure through more physical activity However this approach is associated with only limited success As a result overweight children and adolescents are seeking alternative approaches to weight management such as diets that modify the type and amount of carbohydrates However at this time there is limited data on the safety and efficacy of these diets particularly with younger children This study is a controlled clinical trial that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets to a more standard dietary intervention for the management of pediatric obesity ie portion-controlled moderate fat high carbohydrate diet This study will involve 150 overweight children ages 7 to 12 who will be randomly assigned to one of the three diet groups for 12 months The effects of each diet will be determined by measuring changes in anthropometric measures body weight height body mass index waist circumference body composition other cardiovascular risk factors blood pressure fasting lipid profile fasting glucose and insulin and inflammatory markers of cardiovascular disease and measures of psychological well-being and mental status The results of this study will provide needed information to the public in their quest for safe effective and health-promoting weight management strategies for obese children Such information is vital if we are to address the obesity epidemic in the United States
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