Water Induced Thermogenesis in Obese Children

Tracking Information
First Submitted Date	November 19, 2008
First Posted Date	November 20, 2008
Results First Submitted Date	June 21, 2009
Results First Posted Date	November 25, 2009
Last Update Posted Date	August 7, 2013
Study Start Date	December 2008
Actual Primary Completion Date	March 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: August 1, 2013)	Post-drinking Metabolic Rate [ Time Frame: 1 hour ]resting metabolic rate after drinking water; Baseline Metabolic Rate [ Time Frame: baseline ]baseline metabolic rate
Original Primary Outcome Measures; (submitted: November 19, 2008)	resting metabolic rate [ Time Frame: 2 hours ]
Change History	Complete list of historical versions of study NCT00794469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Water Induced Thermogenesis in Obese Children
Official Title	Water Induced Thermogenesis in Obese Children
Brief Summary	Drinking water is largely advocated for obesity prevention and management. Recent studies have suggested that water has a thermogenic effect, this has not been examined in children. In this study, we will measure the resting metabolic rate of 21 obese children before, and during drinking cold (4 degrees centigrade)water for up to 60 minutes.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	obese children participating in a lifestyle education and weight management program.
Condition	Obesity
Intervention	Other: Water; Children will drink 10 cc/kg of cold water(4 degrees centigrade)
Study Groups/Cohorts	Water; obese children (body mass index > 95th percentile for age and sex) that will drink cold water; Intervention: Other: Water
Publications *	Boschmann M, Steiniger J, Hille U, Tank J, Adams F, Sharma AM, Klaus S, Luft FC, Jordan J. Water-induced thermogenesis. J Clin Endocrinol Metab. 2003 Dec;88(12):6015-9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: October 22, 2009)	21
Original Estimated Enrollment; (submitted: November 19, 2008)	40
Actual Study Completion Date	March 2009
Actual Primary Completion Date	March 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: obesity; agreement and informed consent Exclusion Criteria: non-agreement
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Years to 13 Years (Child)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Israel
Removed Location Countries
Administrative Information
NCT Number	NCT00794469
Other Study ID Numbers	GDR-HMO-CTIL
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gal Dubnov-Raz, Hadassah Medical Organization
Study Sponsor	Hadassah Medical Organization
Collaborators	Eden Springs
Investigators	Not Provided
PRS Account	Hadassah Medical Organization
Verification Date	November 2008