<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250261</url>
  </required_header>
  <id_info>
    <org_study_id>179</org_study_id>
    <nct_id>NCT02250261</nct_id>
  </id_info>
  <brief_title>Socio-ecological Intervention to Promote Active Commuting to Work</brief_title>
  <acronym>KÄPY</acronym>
  <official_title>Socio-ecological Intervention to Promote Active Commuting to Work</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UKK Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tampere University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Transport and Streets, City of Tampere</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ecofellows Ltd, City of Tampere</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Graz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UKK Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background Cycling and walking to work is a natural way of increasing physical activity in a&#xD;
      working population. However, the evidence on the effectiveness and cost savings of promoting&#xD;
      active work commuting (ACW) is thin. This cluster-randomized, controlled study aims to&#xD;
      promote ACW with environmental, social and behavioral strategies in two large workplace areas&#xD;
      in Tampere, Finland. The paper de-scribes the protocol, evaluation and baseline findings of&#xD;
      the study.&#xD;
&#xD;
      Methods The enrollment of the workplaces took place in 2014-15. In Phase 1, the impacts of&#xD;
      environmental strategies (improvements to the walking and cycling trails) were evaluated in&#xD;
      Area1 including 11 workplaces. In Phase 2, five more workplaces were recruited from Area2 to&#xD;
      evaluate the impacts of social and behavioral strategies accustomed for each workplace. The&#xD;
      workplaces in both areas were then randomized into experimental (EXP, n=6+2) and comparison&#xD;
      group (COM, n=5+3). EXP promoted ACW with social and behavioral strategies; COM participated&#xD;
      in data collection only but will have the same support post-intervention. The primary outcome&#xD;
      is the change in employees' self-reported and accelerometer-based ACW. The secondary outcomes&#xD;
      include e.g. the changes in employees' self-rated health and subjective wellbeing at work,&#xD;
      the change in the number of walkers and cyclists based on the traffic calculations and the&#xD;
      change in the quality of walking and cycling trails based on camera auditing (Area1 only).&#xD;
      External validity of the intervention is as-sessed with the compliance rates of the&#xD;
      workplaces and employees as well as with the fidelity of the environmental, social and&#xD;
      behavioral strategies. Health Economic Assessment Tool for Cycling and Walking (HEAT) is used&#xD;
      to assess the cost savings of the multilevel intervention. In addition, environmental&#xD;
      variables and types that promote ACW and mediate and moderate the effects of environmental&#xD;
      strategies are examined.&#xD;
&#xD;
      Results and discussion This study is one of the first in Finland to combine interdisciplinary&#xD;
      collaboration between practi-tioners and researchers working in the fields of transportation,&#xD;
      urban design, physical activity and sustainable development to promote ACW. The findings&#xD;
      benefit all stakeholders interested in pro-moting ACW in urban context. The study will also&#xD;
      produce supportive material for promoting ACW at the workplaces.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-reported means of transportation to work</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of employees walking or cycling to work (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported weekly AWC</measure>
    <time_frame>1 year</time_frame>
    <description>Mean number of days employees walk or cycle to work</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in accelerometer-based daily duration of walking and cycling to work</measure>
    <time_frame>1 year</time_frame>
    <description>Daily minutes of AWC (mean)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-rated health</measure>
    <time_frame>1 year</time_frame>
    <description>Employees self-reported health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective well-being at work</measure>
    <time_frame>1 year</time_frame>
    <description>Includes six indicators self-reported by the employees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in restrictions to ACW</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported by the employees and grouped into four levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in motivation for ACW</measure>
    <time_frame>1 year</time_frame>
    <description>Includes six indicators self-reported by the employees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in injuries due to ACW</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported by the employees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the use of the main walking and cycling trail (Area1)</measure>
    <time_frame>1 year</time_frame>
    <description>Measured with fixed-point traffic calculations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the quality of the main walking and cycling trail</measure>
    <time_frame>1 year</time_frame>
    <description>Audited by cycling the trails with GPS</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost-savings</measure>
    <time_frame>1 year</time_frame>
    <description>HEAT</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>1 year</time_frame>
    <description>cost-effectiveness ratio</description>
  </other_outcome>
  <other_outcome>
    <measure>Environmental evaluation</measure>
    <time_frame>1 year</time_frame>
    <description>Urban environmental variables and types</description>
  </other_outcome>
  <other_outcome>
    <measure>Environmental evaluation</measure>
    <time_frame>1 year</time_frame>
    <description>Variables, which mediate and moderate the effects of environmental strategies</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1500</enrollment>
  <condition>Active Travel</condition>
  <arm_group>
    <arm_group_label>KÄPY group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Workplaces, which are supported to promote employees' ACW.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Workplaces, which are not supported to promote employees' ACW but will be offered support to do so after the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>KÄPY</intervention_name>
    <arm_group_label>KÄPY group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All voluntary employees in the workplaces located in the specific area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Minna Aittasalo, D.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKK Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UKK Institute</name>
      <address>
        <city>Tampere</city>
        <state>Pirkanmaa</state>
        <zip>33500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The UKK Institute for Health Promotion Research</name>
      <address>
        <city>Tampere</city>
        <state>Pirkanmaa</state>
        <zip>33501</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <link>
    <url>http://www.ukkinstituutti.fi</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <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</citation>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UKK Institute</investigator_affiliation>
    <investigator_full_name>Minna Aittasalo</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>walking</keyword>
  <keyword>cycling</keyword>
  <keyword>intervention</keyword>
  <keyword>physical activity</keyword>
  <keyword>environment</keyword>
  <keyword>promotion</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250261
org study id: 179
nct id: NCT02250261
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.

      Methods 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.

      Results 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in self-reported means of transportation to work
time frame: 1 year
description: Proportion of employees walking or cycling to work (%)
measure: Change in self-reported weekly AWC
time frame: 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
time frame: 1 year
description: Daily minutes of AWC (mean)
measure: Change in self-rated health
time frame: 1 year
description: Employees self-reported health
measure: Change in subjective well-being at work
time frame: 1 year
description: Includes six indicators self-reported by the employees
measure: Change in restrictions to ACW
time frame: 1 year
description: Self-reported by the employees and grouped into four levels
measure: Change in motivation for ACW
time frame: 1 year
description: Includes six indicators self-reported by the employees
measure: Change in injuries due to ACW
time frame: 1 year
description: Self-reported by the employees
measure: Change in the use of the main walking and cycling trail (Area1)
time frame: 1 year
description: Measured with fixed-point traffic calculations
measure: Change in the quality of the main walking and cycling trail
time frame: 1 year
description: Audited by cycling the trails with GPS
measure: Cost-savings
time frame: 1 year
description: HEAT
measure: Cost-effectiveness
time frame: 1 year
description: cost-effectiveness ratio
measure: Environmental evaluation
time frame: 1 year
description: Urban environmental variables and types
measure: Environmental evaluation
time frame: 1 year
description: Variables, which mediate and moderate the effects of environmental strategies
arm group label: KÄPY group
arm group type: Experimental
description: Workplaces, which are supported to promote employees' ACW.
arm group label: Comparison group
arm group type: No Intervention
description: Workplaces, which are not supported to promote employees' ACW but will be offered support to do so after the study.
intervention type: Behavioral
intervention name: KÄPY
arm group label: KÄPY group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Minna Aittasalo, D.Sc.
role: Principal Investigator
affiliation: UKK Institute
facility: 
facility: 
country: Finland
url: http://www.ukkinstituutti.fi
description: Related Info
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
responsible party type: Principal Investigator
investigator affiliation: UKK Institute
investigator full name: Minna Aittasalo
investigator title: Senior Researcher