Role of Carbohydrate Modification in Weight Management Among Obese Children

Study Overview
=================
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.

Official Title
-----------------
Role of Carbohydrate Modification in Weight Management Among Obese Children

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Low carbohydrate, reduced glycemic load, and a control diet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low carbohydrate, reduced glycemic load, control diet<br> | Behavioral: Low carbohydrate, reduced glycemic load, and a control diet<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity (3-day physical activity records and pedometer readings) |  | 3-month, 6-month and 12-month | 
| compliance with behavioral intervention (frequency rewards were earned) |  | weekly | 
| attendance at group and individual sessions during initial 3-month intervention |  | 3-month, 6-month and 12-month | 
| Sexual Maturity Rating |  | baseline | 
| Hunger/Satiety assessment (Three-Factor Eating Questionnaire) |  | baseline, 3-month, 6-month and 12-month | 
| Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood obesity, weight management, dietary interventions, cardiovascular disease risk factors