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Role of Carbohydrate Modification in Weight Management Among Obese Children

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate, reduced glycemic load, and a control diet
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring childhood obesity, weight management, dietary interventions, cardiovascular disease risk factors

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 7-12 years Body mass index >95th percentile and BMI z-score no greater than 2.65 Normal fasting blood glucose of less than 100 mg/dL Age-appropriate cognitive and behavioral skills Absence of developmental or physical disabilities Capability to function independently in group exercise sessions Commitment of parent/guardian to attend scheduled meetings for 12-month period Exclusion Criteria: Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia Chronic infections Uncompensated or labile mental illness Chronic or intermittent use of corticosteroids Specific medications that may alter lipid, glucose, bone metabolism or appetite

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low carbohydrate, reduced glycemic load, control diet

Arm Description

Outcomes

Primary Outcome Measures

The outcomes listed below will be obtained at baseline,3-month,
6-month and 12-month assessments unless otherwise noted,body weight,
height,body mass index,waist circumference,percent body fat,
adipose mass,lean body mass,bone mineral density,fasting lipid profile,
fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),

Secondary Outcome Measures

physical activity (3-day physical activity records and pedometer readings)
compliance with behavioral intervention (frequency rewards were earned)
attendance at group and individual sessions during initial 3-month intervention
Sexual Maturity Rating
Hunger/Satiety assessment (Three-Factor Eating Questionnaire)
Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group

Full Information

First Posted
September 15, 2005
Last Updated
February 4, 2015
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Thrasher Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00215111
Brief Title
Role of Carbohydrate Modification in Weight Management Among Obese Children
Official Title
Role of Carbohydrate Modification in Weight Management Among Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Thrasher Research Fund

4. Oversight

5. Study Description

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 (i.e. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
childhood obesity, weight management, dietary interventions, cardiovascular disease risk factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate, reduced glycemic load, control diet
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate, reduced glycemic load, and a control diet
Primary Outcome Measure Information:
Title
The outcomes listed below will be obtained at baseline,3-month,
Time Frame
3 month
Title
6-month and 12-month assessments unless otherwise noted,body weight,
Time Frame
6-month and 12-month
Title
height,body mass index,waist circumference,percent body fat,
Time Frame
baseline, 3-month, 6-month and 12-month
Title
adipose mass,lean body mass,bone mineral density,fasting lipid profile,
Time Frame
baseline, 3-month, 6-month and 12-month
Title
fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),
Time Frame
baseline, 3-month, 6-month and 12-month
Secondary Outcome Measure Information:
Title
physical activity (3-day physical activity records and pedometer readings)
Time Frame
3-month, 6-month and 12-month
Title
compliance with behavioral intervention (frequency rewards were earned)
Time Frame
weekly
Title
attendance at group and individual sessions during initial 3-month intervention
Time Frame
3-month, 6-month and 12-month
Title
Sexual Maturity Rating
Time Frame
baseline
Title
Hunger/Satiety assessment (Three-Factor Eating Questionnaire)
Time Frame
baseline, 3-month, 6-month and 12-month
Title
Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 7-12 years Body mass index >95th percentile and BMI z-score no greater than 2.65 Normal fasting blood glucose of less than 100 mg/dL Age-appropriate cognitive and behavioral skills Absence of developmental or physical disabilities Capability to function independently in group exercise sessions Commitment of parent/guardian to attend scheduled meetings for 12-month period Exclusion Criteria: Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia Chronic infections Uncompensated or labile mental illness Chronic or intermittent use of corticosteroids Specific medications that may alter lipid, glucose, bone metabolism or appetite
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley Kirk, Ph.D., R.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

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Role of Carbohydrate Modification in Weight Management Among Obese Children

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