Role of Carbohydrate Modification in Weight Management Among Obese Children
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ClinicalTrials.gov Identifier: NCT00215111
Recruitment Status :
First Posted : September 22, 2005
Last Update Posted : February 5, 2015
Children's Hospital Medical Center, Cincinnati
Thrasher Research Fund
Information provided by (Responsible Party):
Shelley Kirk, Ph.D., R.D., L.D., Children's Hospital Medical Center, Cincinnati
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.
Condition or disease
Behavioral: Low carbohydrate, reduced glycemic load, and a control diet
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.
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Layout table for eligibility information
Ages Eligible for Study:
7 Years to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia
Uncompensated or labile mental illness
Chronic or intermittent use of corticosteroids
Specific medications that may alter lipid, glucose, bone metabolism or appetite