Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-04-05 @ 3:53 AM
Study NCT ID:
NCT02250261
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socio-ecological Intervention to Promote Active Commuting to Work
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost-savings', 'timeFrame': '1 year', 'description': 'HEAT'}, {'measure': 'Cost-effectiveness', 'timeFrame': '1 year', 'description': 'cost-effectiveness ratio'}, {'measure': 'Environmental evaluation', 'timeFrame': '1 year', 'description': 'Urban environmental variables and types'}, {'measure': 'Environmental evaluation', 'timeFrame': '1 year', 'description': 'Variables, which mediate and moderate the effects of environmental strategies'}], 'primaryOutcomes': [{'measure': 'Change in self-reported means of transportation to work', 'timeFrame': '1 year', 'description': 'Proportion of employees walking or cycling to work (%)'}, {'measure': 'Change in self-reported weekly AWC', 'timeFrame': '1 year', 'description': 'Mean number of days employees walk or cycle to work'}, {'measure': 'Change in accelerometer-based daily duration of walking and cycling to work', 'timeFrame': '1 year', 'description': 'Daily minutes of AWC (mean)'}], 'secondaryOutcomes': [{'measure': 'Change in self-rated health', 'timeFrame': '1 year', 'description': 'Employees self-reported health'}, {'measure': 'Change in subjective well-being at work', 'timeFrame': '1 year', 'description': 'Includes six indicators self-reported by the employees'}, {'measure': 'Change in restrictions to ACW', 'timeFrame': '1 year', 'description': 'Self-reported by the employees and grouped into four levels'}, {'measure': 'Change in motivation for ACW', 'timeFrame': '1 year', 'description': 'Includes six indicators self-reported by the employees'}, {'measure': 'Change in injuries due to ACW', 'timeFrame': '1 year', 'description': 'Self-reported by the employees'}, {'measure': 'Change in the use of the main walking and cycling trail (Area1)', 'timeFrame': '1 year', 'description': 'Measured with fixed-point traffic calculations'}, {'measure': 'Change in the quality of the main walking and cycling trail', 'timeFrame': '1 year', 'description': 'Audited by cycling the trails with GPS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['walking', 'cycling', 'intervention', 'physical activity', 'environment', 'promotion'], 'conditions': ['Active Travel']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Aittasalo M, Tiilikainen J, Tokola K, Seimelä T, Sarjala S-M, Metsäpuro P, Hynynen A, Suni J, Sievänen H, Vähä-Ypyä H, Vaismaa K, Vakkala O, Foster C, Titze S, Vasankari T. Socio-Ecological Intervention to Promote Active Commuting to Work: Protocol and Baseline Findings of a Cluster Randomized Controlled Trial in Finland. Int J Environ Res Public Health. 2017 Oct; 14(10): 1257. Published online 2017 Oct 20. doi: 10.3390/ijerph14101257'}], 'seeAlsoLinks': [{'url': 'http://www.ukkinstituutti.fi', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Background Cycling and walking to work is a natural way of increasing physical activity in a working population. However, the evidence on the effectiveness and cost savings of promoting active work commuting (ACW) is thin. This cluster-randomized, controlled study aims to promote ACW with environmental, social and behavioral strategies in two large workplace areas in Tampere, Finland. The paper de-scribes the protocol, evaluation and baseline findings of the study.\n\nMethods The enrollment of the workplaces took place in 2014-15. In Phase 1, the impacts of environmental strategies (improvements to the walking and cycling trails) were evaluated in Area1 including 11 workplaces. In Phase 2, five more workplaces were recruited from Area2 to evaluate the impacts of social and behavioral strategies accustomed for each workplace. The workplaces in both areas were then randomized into experimental (EXP, n=6+2) and comparison group (COM, n=5+3). EXP promoted ACW with social and behavioral strategies; COM participated in data collection only but will have the same support post-intervention. The primary outcome is the change in employees' self-reported and accelerometer-based ACW. The secondary outcomes include e.g. the changes in employees' self-rated health and subjective wellbeing at work, the change in the number of walkers and cyclists based on the traffic calculations and the change in the quality of walking and cycling trails based on camera auditing (Area1 only). External validity of the intervention is as-sessed with the compliance rates of the workplaces and employees as well as with the fidelity of the environmental, social and behavioral strategies. Health Economic Assessment Tool for Cycling and Walking (HEAT) is used to assess the cost savings of the multilevel intervention. In addition, environmental variables and types that promote ACW and mediate and moderate the effects of environmental strategies are examined.\n\nResults and discussion This study is one of the first in Finland to combine interdisciplinary collaboration between practi-tioners and researchers working in the fields of transportation, urban design, physical activity and sustainable development to promote ACW. The findings benefit all stakeholders interested in pro-moting ACW in urban context. The study will also produce supportive material for promoting ACW at the workplaces."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll voluntary employees in the workplaces located in the specific area\n\nExclusion Criteria:\n\nNo exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02250261', 'acronym': 'KÄPY', 'briefTitle': 'Socio-ecological Intervention to Promote Active Commuting to Work', 'organization': {'class': 'OTHER', 'fullName': 'UKK Institute'}, 'officialTitle': 'Socio-ecological Intervention to Promote Active Commuting to Work', 'orgStudyIdInfo': {'id': '179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KÄPY group', 'description': "Workplaces, which are supported to promote employees' ACW.", 'interventionNames': ['Behavioral: KÄPY']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison group', 'description': "Workplaces, which are not supported to promote employees' ACW but will be offered support to do so after the study."}], 'interventions': [{'name': 'KÄPY', 'type': 'BEHAVIORAL', 'armGroupLabels': ['KÄPY group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33500', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'UKK Institute', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '33501', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'The UKK Institute for Health Promotion Research', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Minna Aittasalo, D.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKK Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UKK Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University of Technology', 'class': 'OTHER'}, {'name': 'Department of Transport and Streets, City of Tampere', 'class': 'UNKNOWN'}, {'name': 'Ecofellows Ltd, City of Tampere', 'class': 'UNKNOWN'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'University of Graz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Minna Aittasalo', 'investigatorAffiliation': 'UKK Institute'}}}}