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Water Induced Thermogenesis in Obese Children

This study has been completed.
Sponsor:
Collaborator:
Eden Springs
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00794469
First received: November 19, 2008
Last updated: August 1, 2013
Last verified: November 2008
History of Changes
Results First Received: June 21, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Obesity
Intervention: Other: Water

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Water obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)

Participant Flow:   Overall Study
    Water
STARTED   21 
COMPLETED   21 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Water obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)

Baseline Measures
   Water 
Overall Participants Analyzed 
[Units: Participants]
 		 21 
Age 
[Units: Participants]
 		 
<=18 years   21 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 9.8  (1.4) 
Gender 
[Units: Participants]
 		 
Female   10 
Male   11 
Region of Enrollment 
[Units: Participants]
 		 
Israel   21 
resting metabolic rate [1] 
[Units: Kcal/d]
Mean (Standard Deviation) 		 1109  (385) 
[1] resting metabolic rate


  Outcome Measures
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1.  Primary:   Post-drinking Metabolic Rate   [ Time Frame: 1 hour ]
  Show Outcome Measure 1

2.  Primary:   Baseline Metabolic Rate   [ Time Frame: baseline ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gal Dubnov-Raz
Organization: Hadassah Medical Organization
phone: +972+54-4570250
e-mail: gal-d@bezeqint.net


Publications:


Responsible Party: Gal Dubnov-Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00794469     History of Changes
Other Study ID Numbers: GDR-HMO-CTIL
Study First Received: November 19, 2008
Results First Received: June 21, 2009
Last Updated: August 1, 2013