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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The outcomes listed below will be obtained at baseline,3-month,
Time frame: 3 month
6-month and 12-month assessments unless otherwise noted,body weight,
Time frame: 6-month and 12-month
height,body mass index,waist circumference,percent body fat,
Time frame: baseline, 3-month, 6-month and 12-month
adipose mass,lean body mass,bone mineral density,fasting lipid profile,
Time frame: baseline, 3-month, 6-month and 12-month
fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),
Time frame: baseline, 3-month, 6-month and 12-month
physical activity (3-day physical activity records and pedometer readings)
Time frame: 3-month, 6-month and 12-month
compliance with behavioral intervention (frequency rewards were earned)
Time frame: weekly
attendance at group and individual sessions during initial 3-month intervention
Time frame: 3-month, 6-month and 12-month
Sexual Maturity Rating
Time frame: baseline
Hunger/Satiety assessment (Three-Factor Eating Questionnaire)
Time frame: 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
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Time frame: baseline