Status:
COMPLETED
The Role of Exercise and Diet in Weight Loss in Obese Children
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
D-Cure, Israel
Soroka University Medical Center
Conditions:
Pediatric Obesity
Eligibility:
All Genders
6-11 years
Phase:
NA
Brief Summary
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI\> 95th pe...
Detailed Description
A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children ...
Eligibility Criteria
Inclusion
- Obese preadolescent children 6-11 year-old with BMI\> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Exclusion
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
- Presence of untreated hypothyroidism
- Participation in a clinical study during the last month
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00461994
Start Date
April 1 2004
End Date
December 1 2006
Last Update
April 18 2007
Active Locations (2)
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1
Soroka Medical Center
Beersheba, Israel
2
Schneider Children's Medical Center
Petah Tikva, Israel, 49202