Active TravelKÄPYNCT02250261
Socio-ecological Intervention to Promote Active Commuting to Work
A study testing KÄPY in people with Active Travel, run by UKK Institute at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Travel
- What is being tested?
- KÄPY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesFinland
- Study dates
- Aug 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All voluntary employees in the workplaces located in the specific area
Who cannot join
- No exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
UKK Institute
Tampere, Pirkanmaa, 33500
The UKK Institute for Health Promotion Research
Tampere, Pirkanmaa, 33501
About this study
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.
- Conditions
- Active Travel
- Being tested
- KÄPY
- Keywords
- walking, cycling, intervention, physical activity, environment, promotion
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KÄPYBehavioural
| Study group | Role | What they receive |
|---|---|---|
| KÄPY group | Experimental | Workplaces, which are supported to promote employees' ACW. Receives: Behavioral: KÄPY |
| Comparison group | No intervention | Workplaces, which are not supported to promote employees' ACW but will be offered support to do so after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported means of transportation to work
Proportion of employees walking or cycling to work (%)
Measured: 1 year
Change in self-reported weekly AWC
Mean number of days employees walk or cycle to work
Measured: 1 year
Change in accelerometer-based daily duration of walking and cycling to work
Daily minutes of AWC (mean)
Measured: 1 year
Secondary outcomes (7)
Change in self-rated health
Employees self-reported health
Measured: 1 year
Change in subjective well-being at work
Includes six indicators self-reported by the employees
Measured: 1 year
Change in restrictions to ACW
Self-reported by the employees and grouped into four levels
Measured: 1 year
Change in motivation for ACW
Includes six indicators self-reported by the employees
Measured: 1 year
Change in injuries due to ACW
Self-reported by the employees
Measured: 1 year
Change in the use of the main walking and cycling trail (Area1)
Measured with fixed-point traffic calculations
Measured: 1 year
Change in the quality of the main walking and cycling trail
Audited by cycling the trails with GPS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active TravelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology, Department of Transport and Streets, City of Tampere, Ecofellows Ltd, City of Tampere, University of Oxford, University of Graz
- Responsible party
- Principal investigator, Minna Aittasalo, UKK Institute
- Investigators
- Minna Aittasalo, D.Sc., Principal investigator, UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250261
- Sponsor's protocol ID
- 179
- Acronym
- KÄPY
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2014
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socio-ecological Intervention to Promote Active Commuting to Work
- ClinicalTrials.gov ID
- NCT02250261
- Acronym / sponsor ID
- KÄPY / 179
- Conditions
- Active Travel
- Keywords
- walking, cycling, intervention, physical activity, environment, promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Tampere University of Technology, Department of Transport and Streets, City of Tampere, Ecofellows Ltd, City of Tampere, University of Oxford, University of Graz
- Study start
- Aug 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KÄPY group | Experimental | Behavioral: KÄPYWorkplaces, which are supported to promote employees' ACW. |
| Comparison group | No intervention | –Workplaces, which are not supported to promote employees' ACW but will be offered support to do so after the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All voluntary employees in the workplaces located in the specific area
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KÄPY | Behavioural | KÄPY group |
Primary outcome
Change in self-reported means of transportation to work
Time frame: 1 year
Proportion of employees walking or cycling to work (%)
Change in self-reported weekly AWC
Time frame: 1 year
Mean number of days employees walk or cycle to work
Change in accelerometer-based daily duration of walking and cycling to work
Time frame: 1 year
Daily minutes of AWC (mean)
7 secondary outcomes
Change in self-rated health
Time frame: 1 year
Change in subjective well-being at work
Time frame: 1 year
Change in restrictions to ACW
Time frame: 1 year
Change in motivation for ACW
Time frame: 1 year
Change in injuries due to ACW
Time frame: 1 year
Change in the use of the main walking and cycling trail (Area1)
Time frame: 1 year
Change in the quality of the main walking and cycling trail
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Results publicationAittasalo 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
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minna Aittasalo, D.Sc. principal investigator
UKK Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KÄPY in people with Active Travel, run by UKK Institute at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported means of transportation to work (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02250261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018; AzTrials last refreshed its copy on 1 Nov 2026.