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Role of Carbohydrate Modification in Weight Management Among Obese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215111
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 5, 2015
Thrasher Research Fund
Information provided by (Responsible Party):
Shelley Kirk, Ph.D., R.D., L.D., Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Low carbohydrate, reduced glycemic load, and a control diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Carbohydrate Modification in Weight Management Among Obese Children
Study Start Date : March 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Low carbohydrate, reduced glycemic load, control diet Behavioral: Low carbohydrate, reduced glycemic load, and a control diet

Primary Outcome Measures :
  1. The outcomes listed below will be obtained at baseline,3-month, [ Time Frame: 3 month ]
  2. 6-month and 12-month assessments unless otherwise noted,body weight, [ Time Frame: 6-month and 12-month ]
  3. height,body mass index,waist circumference,percent body fat, [ Time Frame: baseline, 3-month, 6-month and 12-month ]
  4. adipose mass,lean body mass,bone mineral density,fasting lipid profile, [ Time Frame: baseline, 3-month, 6-month and 12-month ]
  5. fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment), [ Time Frame: baseline, 3-month, 6-month and 12-month ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215111

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Thrasher Research Fund
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Principal Investigator: Shelley Kirk, Ph.D., R.D. Children's Hospital Medical Center, Cincinnati

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Responsible Party: Shelley Kirk, Ph.D., R.D., L.D., Associate Professor, Children's Hospital Medical Center, Cincinnati Identifier: NCT00215111    
Other Study ID Numbers: 02819-8
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Shelley Kirk, Ph.D., R.D., L.D., Children's Hospital Medical Center, Cincinnati:
childhood obesity
weight management
dietary interventions
cardiovascular disease risk factors
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms