Role of Carbohydrate Modification in Weight Management Among Obese Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00215111
First received: September 15, 2005
Last updated: November 2, 2007
Last verified: November 2007
  Purpose

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 Intervention
Childhood Obesity
Behavioral: Low carbohydrate, reduced glycemic load, and a control diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Carbohydrate Modification in Weight Management Among Obese Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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,
  • 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
  • parent/guardian weight
  • parent/guardian body mass index
  • 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

Estimated Enrollment: 150
Study Start Date: March 2005
Estimated Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215111

Locations
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
Investigators
Principal Investigator: Shelley Kirk, Ph.D., R.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215111     History of Changes
Other Study ID Numbers: 02819-8
Study First Received: September 15, 2005
Last Updated: November 2, 2007
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
childhood obesity
weight management
dietary interventions
cardiovascular disease risk factors

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014