Status:
COMPLETED
Role of Carbohydrate Modification in Weight Management Among Obese Children
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Childhood Obesity
Eligibility:
All Genders
7-12 years
Phase:
NA
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 ov...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00215111
Start Date
March 1 2005
End Date
June 1 2008
Last Update
February 5 2015
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229