Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT00554294
Status:
COMPLETED
Last Update Posted:
2009-07-16
First Post:
2007-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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': 'D004777', 'term': 'Environment'}], 'ancestors': [{'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kersting@fke-do.de', 'phone': '0049 231 79221013', 'title': 'Dr. Mathilde Kersting', 'organization': 'Research Institute of Child Nutrition, Dortmund'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1309', 'groupId': 'OG000'}, {'value': '1641', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Schools did not receive any intervention.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Schools received water fountains, drinking bottles and lessons as intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '683', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.98', 'groupDescription': 'adjusted for overweight at baseline, age at baseline,sex and clustering by school', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'one school year', 'description': 'Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Drinks', 'timeFrame': 'one school year', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Activity and Inactivity', 'timeFrame': 'one school year', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Water Flow of the Water Dispensers', 'timeFrame': 'one school year', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Parameters of Process Evaluation (Acceptance, Feasibility)', 'timeFrame': '1,5 years', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Schools did not receive any intervention.'}, {'id': 'FG001', 'title': 'Intervention Group', 'description': 'Schools received water fountains, drinking bottles and lessons as intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1469'}, {'groupId': 'FG001', 'numSubjects': '1721'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1309'}, {'groupId': 'FG001', 'numSubjects': '1641'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '80'}]}]}], 'recruitmentDetails': 'second and third graders of participating schools'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1469', 'groupId': 'BG000'}, {'value': '1721', 'groupId': 'BG001'}, {'value': '3190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Schools did not receive any intervention.'}, {'id': 'BG001', 'title': 'Intervention Group', 'description': 'Schools received water fountains, drinking bottles and lessons as intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '734', 'groupId': 'BG000'}, {'value': '853', 'groupId': 'BG001'}, {'value': '1587', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '735', 'groupId': 'BG000'}, {'value': '868', 'groupId': 'BG001'}, {'value': '1603', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prevalence of overweight', 'classes': [{'title': 'overweight', 'categories': [{'measurements': [{'value': '378', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '782', 'groupId': 'BG002'}]}]}, {'title': 'non-overweight', 'categories': [{'measurements': [{'value': '1091', 'groupId': 'BG000'}, {'value': '1317', 'groupId': 'BG001'}, {'value': '2408', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Overweight was defined according to the standard of the International Obesity Task Force', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2950}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-27', 'studyFirstSubmitDate': '2007-11-05', 'resultsFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-27', 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overweight', 'timeFrame': 'one school year', 'description': 'Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)'}], 'secondaryOutcomes': [{'measure': 'Intake of Drinks', 'timeFrame': 'one school year'}, {'measure': 'Physical Activity and Inactivity', 'timeFrame': 'one school year'}, {'measure': 'Water Flow of the Water Dispensers', 'timeFrame': 'one school year'}, {'measure': 'Parameters of Process Evaluation (Acceptance, Feasibility)', 'timeFrame': '1,5 years'}]}, 'conditionsModule': {'keywords': ['children', 'primary prevention', 'environmental change', 'behavioural change', 'school setting', 'changing of drinking habits', 'promotion of drinking tap water'], 'conditions': ['Overweight']}, 'referencesModule': {'references': [{'pmid': '19336356', 'type': 'RESULT', 'citation': 'Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics. 2009 Apr;123(4):e661-7. doi: 10.1542/peds.2008-2186.'}, {'pmid': '19713953', 'type': 'DERIVED', 'citation': 'Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Immigrational background affects the effectiveness of a school-based overweight prevention program promoting water consumption. Obesity (Silver Spring). 2010 Mar;18(3):528-34. doi: 10.1038/oby.2009.270. Epub 2009 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.', 'detailedDescription': 'Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.\n\nTo analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children in 2nd and 3rd grade of selected elementary schools\n\nExclusion Criteria:\n\n* parental consent'}, 'identificationModule': {'nctId': 'NCT00554294', 'acronym': 'trinkfit', 'briefTitle': 'Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Research Institute of Child Nutrition, Dortmund'}, 'officialTitle': 'Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial', 'orgStudyIdInfo': {'id': '05HS026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control schools had school curriculum as usual and did not receive environmental intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention schools received water dispensers, drinking bottles and lessons as intervention.', 'interventionNames': ['Behavioral: environmental and behavioral change']}], 'interventions': [{'name': 'environmental and behavioral change', 'type': 'BEHAVIORAL', 'description': 'In intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mathilde Kersting, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Insitute of Child Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Institute of Child Nutrition, Dortmund', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Research Institute of Child Nutrition, Dortmund', 'oldOrganization': 'Research Institute of Child Nutrition, Dortmund'}}}}