Viewing Study NCT03163004


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Study NCT ID: NCT03163004
Status: COMPLETED
Last Update Posted: 2017-10-24
First Post: 2017-05-17
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Implementation of Standing Desks at School
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One intervention and one control condition'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-20', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Decrease in children's sedentary time during school hours", 'timeFrame': 'One schoolyear', 'description': "In the questionnaire, following item was used to subjectively assess the outcome: 'On average how many hours do you spent sedentary in class?' Answer categories ranged from 'None' to 'More than 7 hours per day'. In addition, a subsample wore an ActivPAL inclinometer to objectively measure sedentary time. This thigh-worn device uses accelerometer-derived information about thigh position to calculate the outcome."}], 'secondaryOutcomes': [{'measure': 'Possible decrease in TV time on week- and weekend days', 'timeFrame': 'One schoolyear', 'description': "In the questionnaire, children and adolescents were asked on average how many hours they spent in front of a television, separately for week- and weekend days. Answer categories ranged from 'Non' to 'More than 4 hours per day'. The items are derived from the reliable and valid ENERGY-questionnaire."}, {'measure': 'Possible decrease in computer time on week- and weekend days', 'timeFrame': 'One schoolyear', 'description': "In the questionnaire, children and adolescents were asked on average how many hours they spent in front of a computer, separately for week- and weekend days. Answer categories ranged from 'Non' to 'More than 4 hours per day'. The items are derived from the reliable and valid ENERGY-questionnaire."}, {'measure': 'Increase in the number of breaks in sedentary activities', 'timeFrame': 'One schoolyear', 'description': "In the questionnaire, children and adolescents were asked on average, how many times they interrupt their TV time, computer time and sitting during school hours. Answer categories ranged from '0' to '4 times or more per hour'. The items were derived from the ENERGY-questionnaire."}, {'measure': 'Improvement of determinants related to breaking up sedentary activities', 'timeFrame': 'One schoolyear', 'description': "In the questionnaire, questions were added on attitude, self-efficacy, preferences and habits related to breaking up sedentary activities, with answer categories ranging from 'Totally agree' to 'Totally disagree'. The items were derived from the ENERGY-questionnaire"}, {'measure': 'Improvement in school well-being', 'timeFrame': 'One schoolyear', 'description': 'Three school-related variables (i.e. relationship with classmates, involvement in organising school activities, and relationship with teachers) were assessed in the questionnaire using items from the Flemish Health Behaviour in School-Aged Children questionnaire.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedentary behavior'], 'conditions': ['Health Behavior']}, 'referencesModule': {'references': [{'pmid': '34555181', 'type': 'DERIVED', 'citation': 'Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.'}, {'pmid': '30261883', 'type': 'DERIVED', 'citation': 'Verloigne M, Ridgers ND, De Bourdeaudhuij I, Cardon G. Effect and process evaluation of implementing standing desks in primary and secondary schools in Belgium: a cluster-randomised controlled trial. Int J Behav Nutr Phys Act. 2018 Sep 27;15(1):94. doi: 10.1186/s12966-018-0726-9.'}]}, 'descriptionModule': {'briefSummary': 'Since sedentary time is related to various health outcomes and is already highly prevalent in childhood and adolescence, effective strategies are needed to tackle this health problem. Children and adolescents spend the majority of the day in a classroom while sitting at a desk. Therefore, the classroom is an important setting for implementing specific strategies to reduce sedentary time.\n\nOne of the strategies that gained more attention during the past years is replacing traditional desks and chairs with standing desks.\n\nThis project evaluates the implementation of standing desks in primary and secondary schools via a clustered randomized controlled trial using an intervention and control condition. Effects on sedentary time during in class, sedentary activities during leisure time, breaks in sedentary time, and related determinants (secondary outcomes) are evaluated.\n\nNext to effect evaluation, it is also equally important to evaluate how teachers and pupils perceive this change in the classroom environment. Both groups need to be positive in order to obtain the adoption and sustainability. Therefore, focus groups with pupils and interviews with teachers are conducted, with a specific focus on the perceived barriers. Moreover, the process evaluation is conducted quantitatively as well by using questionnaires in pupils and teachers.\n\nThe project results will lead to recommendations on how to broadly implement standing desks into primary and secondary schools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pupils of primary schools (5th grade) and secondary schools (10th grade)'}, 'identificationModule': {'nctId': 'NCT03163004', 'briefTitle': 'Implementation of Standing Desks at School', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Implementing Standing Desks in Primary and Secondary Schools to Reduce Sedentary Time: Effect and Process Evaluation.', 'orgStudyIdInfo': {'id': 'FWO13/PDO/191 second term'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Implementation of standing desks in the classroom', 'interventionNames': ['Behavioral: Implementation of standing desks']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Implementation of standing desks', 'type': 'BEHAVIORAL', 'description': 'Three standing desks will be introduced to the classroom', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University, Department of Movement and Sports Sciences', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Greet Cardon', 'investigatorFullName': 'Vakgroepsport', 'investigatorAffiliation': 'University Ghent'}}}}