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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Page 1 of 1 (2 locations)

1

Soroka Medical Center

Beersheba, Israel

2

Schneider Children's Medical Center

Petah Tikva, Israel, 49202