Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-22 @ 2:41 PM
Study NCT ID:
NCT00794469
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2008-11-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Water Induced Thermogenesis in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gal-d@bezeqint.net', 'phone': '+972+54-4570250', 'title': 'Gal Dubnov-Raz', 'organization': 'Hadassah Medical Organization'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Water', 'description': 'obese children (body mass index \\>95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-drinking Metabolic Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Water', 'description': 'obese children (body mass index \\>95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)'}], 'classes': [{'categories': [{'measurements': [{'value': '1487', 'spread': '277', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'resting metabolic rate after drinking water', 'unitOfMeasure': 'kcal/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'Baseline Metabolic Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Water', 'description': 'obese children (body mass index \\>95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)'}], 'classes': [{'categories': [{'measurements': [{'value': '1109', 'spread': '385', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'baseline metabolic rate', 'unitOfMeasure': 'kcal/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Water', 'description': 'obese children (body mass index \\>95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Water', 'description': 'obese children (body mass index \\>95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'resting metabolic rate', 'classes': [{'categories': [{'measurements': [{'value': '1109', 'spread': '385', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'resting metabolic rate', 'unitOfMeasure': 'kcal/d', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2008-11-19', 'resultsFirstSubmitDate': '2009-06-21', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-22', 'studyFirstPostDateStruct': {'date': '2008-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-drinking Metabolic Rate', 'timeFrame': '1 hour', 'description': 'resting metabolic rate after drinking water'}, {'measure': 'Baseline Metabolic Rate', 'timeFrame': 'baseline', 'description': 'baseline metabolic rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Resting metabolic rate'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '14671205', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1210/jc.2003-030780.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'obese children participating in a lifestyle education and weight management program.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity\n* agreement and informed consent\n\nExclusion Criteria:\n\n* non-agreement'}, 'identificationModule': {'nctId': 'NCT00794469', 'briefTitle': 'Water Induced Thermogenesis in Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Water Induced Thermogenesis in Obese Children', 'orgStudyIdInfo': {'id': 'GDR-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Water', 'description': 'obese children (body mass index \\> 95th percentile for age and sex) that will drink cold water', 'interventionNames': ['Other: Water']}], 'interventions': [{'name': 'Water', 'type': 'OTHER', 'description': 'Children will drink 10 cc/kg of cold water(4 degrees centigrade)', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Optimal Sport Medicine Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eden Springs', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Gal Dubnov-Raz', 'oldOrganization': 'Hadassah Medical Organization'}}}}