Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT03283904
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2017-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Schools: Skelmersdale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Control vs Intervention clusters of schools'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'School-day moderate-to-vigorous physical activity (MVPA)', 'timeFrame': '7 days', 'description': 'Minutes of school-day MVPA accrued'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Schools'], 'conditions': ['Physical Activity', 'Sedentary Lifestyle']}, 'referencesModule': {'references': [{'pmid': '28509887', 'type': 'RESULT', 'citation': 'Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5):534. doi: 10.3390/ijerph14050534.'}, {'pmid': '28486972', 'type': 'RESULT', 'citation': "Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z."}]}, 'descriptionModule': {'briefSummary': 'The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention.', 'detailedDescription': "The multi-component intervention is the third and final phase of the AS:Sk project. It will be implemented and evaluated in four of the seven participating schools. The remaining three schools will act as controls and will not implement any physical activity intervention during the period of the research project. Schools will be randomly assigned to either intervention or control conditions. The multi-component intervention will involve multiple areas of the schools' curricula, environments, or policies being targeted. Decisions regarding these intervention components will be influenced by what was deemed effective, and feasible within phase 2 of the project. Phase 2 included a four week trial of three different single component physical activity interventions across all participating schools. Phase 3 will be implemented for at least eight weeks and if successful, it would then be rolled out in the control schools at the end of the project. Participants from both intervention and control schools will take part in the measures for evaluation in this third and final phase of the project."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Year 5 pupil attending participating schools\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03283904', 'acronym': 'AS:Sk', 'briefTitle': 'Active Schools: Skelmersdale', 'organization': {'class': 'OTHER', 'fullName': 'Edge Hill University'}, 'officialTitle': 'Active Schools: Skelmersdale', 'orgStudyIdInfo': {'id': 'KIDSMOVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multicomponent PA intervention', 'description': 'Intervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day', 'interventionNames': ['Other: Multicomponent physical activity intervention']}], 'interventions': [{'name': 'Multicomponent physical activity intervention', 'type': 'OTHER', 'description': 'School-based multicomponent intervention', 'armGroupLabels': ['Multicomponent PA intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L39 4QP', 'city': 'Ormskirk', 'state': 'Lancs', 'country': 'United Kingdom', 'facility': 'Edge Hill University', 'geoPoint': {'lat': 53.56685, 'lon': -2.88178}}], 'overallOfficials': [{'name': 'Stuart J Fairclough', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edge Hill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edge Hill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'West Lancashire Sport Partnership', 'class': 'UNKNOWN'}, {'name': 'West Lancashire Leisure Trust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}