Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 2:30 PM
Study NCT ID:
NCT04956250
Status:
WITHDRAWN
Last Update Posted:
2023-06-26
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traffic Safety Study at Calgary Elementary Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Modified Stepped-Wedge Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants were intended to be directly recruited.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-06-29', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Traffic Speed - Pre-intervention', 'timeFrame': 'At each location, a week of pre-intervention data collection will occur a week prior to the intervention being installed.', 'description': 'Traffic speed of all vehicles who pass by the intervention will be recorded.'}, {'measure': 'Traffic Speed - Post-intervention', 'timeFrame': 'At each location, a week of post-intervention data collection will occur a week after the intervention being installed.', 'description': 'Traffic speed of all vehicles who pass by the intervention will be recorded.'}, {'measure': 'Traffic Speed - Follow-up', 'timeFrame': 'At a random selection of locations (drawn from those that received the intervention during the school year), a week of data collection will occur during the spring following the installation of the intervention.', 'description': 'Traffic speed of all vehicles who pass by the intervention will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Traffic Volume - Pre-intervention', 'timeFrame': 'At each location, a week of pre-intervention data collection will occur a week prior to the intervention being installed.', 'description': 'The number of all vehicles who pass by the intervention will be recorded.'}, {'measure': 'Traffic Volume - Post-intervention', 'timeFrame': 'At each location, a week of post-intervention data collection will occur a week after the intervention being installed.', 'description': 'The number of all vehicles who pass by the intervention will be recorded.'}, {'measure': 'Traffic Volume - Follow-up', 'timeFrame': 'At a random selection of locations (drawn from those that received the intervention during the school year), a week of data collection will occur during the spring following the installation of the intervention.', 'description': 'The number of all vehicles who pass by the intervention will be recorded.'}, {'measure': 'Active Transportation Counts - Pre-intervention', 'timeFrame': 'At each location, a day of pre-intervention data collection will occur a week prior to the intervention being installed. .', 'description': 'The number of people (Adults v Children) who use the intervention location, and mode of travel (e.g. walking, bicycling).'}, {'measure': 'Active Transportation Counts - Post-intervention', 'timeFrame': 'At each location, a day of post-intervention data collection will occur a week after the intervention being installed. .', 'description': 'The number of people (Adults v Children) who use the intervention location, and mode of travel (e.g. walking, bicycling).'}, {'measure': 'Active Transportation Counts - Follow-up', 'timeFrame': 'At a random selection of locations (drawn from those that received the intervention during the school year), a day of data collection will occur during the spring following the installation of the intervention.', 'description': 'The number of people (Adults v Children) who use the intervention location, and mode of travel (e.g. walking, bicycling).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motor Vehicle Injury']}, 'descriptionModule': {'briefSummary': 'Installing specific traffic calming features designed to reduce vehicle speed and volume around schools may lead to a reduction in injury risk for child pedestrians and bicyclists, and may increase numbers of children walking and bicycling to school. Therefore, this study seeks to evaluate the effectiveness of specific built environment features at influencing traffic speed and volume, and active transportation, both immediately following installation and months later.', 'detailedDescription': 'Background Collisions with motor-vehicles are a leading cause of severe child bicyclist and pedestrian injuries in Canada. Injury rates and severity are associated with traffic speeds and volume but may be moderated through traffic calming.\n\nObjective To assess the association of specific traffic calming measures on changes in traffic speed and volume, and active transportation prevalence, around Calgary, Alberta, Canada elementary schools.\n\nDesign This modified stepped-wedge randomized controlled trial was conducted at a sample of public elementary schools, from July 2020 to May 2021. Schools had either traffic calming curbs or in-street signs installed at an intersection within 100 m of the main entrance. The primary outcome was speed of vehicles driving towards or away from intervention. Secondary outcomes were traffic volume driving past the intervention and counts of children using active transportation at the intervention crosswalk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No individual participants are recruited.'}, 'identificationModule': {'nctId': 'NCT04956250', 'briefTitle': 'Traffic Safety Study at Calgary Elementary Schools', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Traffic Safety Study at Calgary Elementary Schools', 'orgStudyIdInfo': {'id': 'REB19-1455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traffic Calming Curb Group', 'description': 'Traffic calming curbs are yellow concrete slabs designed by the City of Calgary to be the same height as other roadside curbs and improve safety by reducing the street width, similar to curb extensions.', 'interventionNames': ['Other: Traffic Calming Curbs']}, {'type': 'EXPERIMENTAL', 'label': 'In-Street Sign Group', 'description': 'In-street pedestrian signs are regulatory signs placed along the centre line of the street, to remind road users of a pedestrian right-of-way at the marked/unmarked crosswalk.', 'interventionNames': ['Other: In-Street Pedestrian Sign']}], 'interventions': [{'name': 'Traffic Calming Curbs', 'type': 'OTHER', 'description': 'Temporary curb extensions, placed at intersections.', 'armGroupLabels': ['Traffic Calming Curb Group']}, {'name': 'In-Street Pedestrian Sign', 'type': 'OTHER', 'description': 'Yield sign placed in middle of road at intersection.', 'armGroupLabels': ['In-Street Sign Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}