Bicycling DistanceNCT03131518
From Cars to Bikes - the Feasibility and Effect of Bicycling for Transportation Among Parents of Toddlers
A study testing Access to an e-bicycle with trailer, Access to a longtail bicycle and Access to a traditional bike with trailer in people with Bicycling Distance and Bicycling Time, run by University of Agder at 1 site in Norway.
Trial summary
There is a need for a greater understanding of e-bikes and their role in the transportation network, and further effects on physical activity (PA) levels and health. Moreover, longtail bikes could meet certain practical needs not sufficiently fulfilled by e-bikes or traditional bikes, hence increased knowledge… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Bicycling Distance, Bicycling Time, Physical Activity Level
- What is being tested?
- Access to an e-bicycle with trailer, Access to a longtail bicycle and Access to a traditional bike with trailer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jun 2017to 25 Jun 2018
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being able to understand and read Norwegian
- having one child born in 2013, 2014 or 2015 attending kindergarten
- being responsible for bringing/picking up the "study child" in the kindergarten ≥5 times per week/at least half of the times
- residing 2-10 km from the workplace
- residing <3 km from the kindergarten and the grocery shop
- having car-access
Show all 9Show fewer
- possessing a smartphone
- being between 167-190 cm tall (due to the size of accessible bicycles)
- having the opportunity to store the bicycles indoors
Who cannot join
- having bicycled more than once weekly during the last 12 months to either the workplace, the kindergarten, or the grocery shop.
- suffering from severe cardiovascular diseases or upper respiratory tract diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Cars to Bikes - the Feasibility and Effect of Using E-bikes, Traditional Bikes and Longtail Bikes for Transportation Among Parents of Children Attending Kindergarten: a Randomized Cross-over Trial
There is a need for a greater understanding of e-bikes and their role in the transportation network, and further effects on physical activity (PA) levels and health. Moreover, longtail bikes could meet certain practical needs not sufficiently fulfilled by e-bikes or traditional bikes, hence increased knowledge regarding their potential and feasibility should be obtained. No intervention study has investigated whether providing an e-bike or a longtail bike over an extended period in a sample of inactive parents of toddlers influence objectively assessed amount of cycling, total PA level, potential mode shifts, and effect on cardiorespiratory fitness, body composition and blood pressure.
Objectives:
Read more
To assess the effect of an intervention where participants have access to an e-bike (including a trailer), a longtail bike and a traditional bike (including a trailer) on the following parameters:
- Objectively assessed amount of biking, total levels of PA, and mode shifts from car/motorized modes to bicycle.
- Cardiorespiratory fitness, blood pressure, body composition, self-reported health and health-related quality of life (HRQoL).
- Experiences with bicycling (el/longtail/traditional) and intrinsic motivation for bicycling.
- How season and weather conditions influence the amount of bicycling (el/longtail/traditional).
Study sample:
A convenience sample consisting of 36 inactive parents of toddlers will be recruited among residents in Kristiansand municipality, Southern Norway.
Measures:
The following measures will be conducted:
- A web-based questionnaire will assess socio-demographics (at baseline only), transportation habits, self-perceived health and HRQoL, and motivation for bicycling for transportation. For the intervention group: at baseline and post all intervention arms, i.e. four times. For the control group: at baseline and after 9 months, i.e. two times.
- Cycling time and distance will be assessed through usage of a cycle computer throughout the entire project period, in total nine months.
- Time spent in moderate-to-vigorous PA (MVPA) will be estimated with the monitor SenseWear Armband Mini (SWA) for seven consecutive days at study start and after 9 months (post-intervention).
- Cardiorespiratory fitness will be measured performing treadmill walking/running, and dual-energy X-ray absorptiometry (DXA) will be used for assessing body composition. In addition, blood pressure, body weight and height (height only at baseline) will be measured at baseline and after 9 months (post-intervention).
- Participants' experiences with and motivation for usage of the different bicycle types will be explored in semi-structured focus group interviews after 3 months, 6 months and 9 months.
- Weather data (temperature, rainfall, snow, etc.) will also be collected.
Scientific contribution:
The present study will add knowledge to relevant and topical areas, i.e. issues related to public health and environmental sustainability, among parents of toddlers, representing an important target group.There is a call for research on the influence of e-bikes on travel behavior and level of MVPA, and whether voluntary cycling with e-bikes could improve health. Moreover, to our knowledge no scientific studies have assessed possible effects of using a longtail bike, on the selected parameters. If the current study reveals promising results, it should be replicated in a larger and more representative sample of parents of toddlers, as well as in other important target groups (e.g. older adults). If findings are positive, inclusion in national public health policies should be considered.
- Conditions
- Bicycling Distance, Bicycling Time, Physical Activity Level, Cardiorespratory Fitness, Body Composition
- Being tested
- Access to an e-bicycle with trailer, Access to a longtail bicycle, Access to a traditional bike with trailer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to an e-bicycle with trailerBehavioural
Participants will be provided with an e-bike with trailer for 3 months.
Access to a longtail bicycleBehavioural
Participants will be provided with a longtail bike for 3 months.
Access to a traditional bike with trailerBehavioural
Participants will be provided with a traditional bicycle with trailer for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| E-bicycle | Other | Access to an e-bicycle will be provided. Receives: Behavioral: Access to an e-bicycle with trailer |
| Longtail bicycle | Other | Access to a longtail bicycle will be provided. Receives: Behavioral: Access to a longtail bicycle |
| Traditional bicycle | Other | Access to a traditional bicycle will be provided. Receives: Behavioral: Access to a traditional bike with trailer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bicycling
Bicycling distance and time will be combined to assess change in total amount of bicycling for transportation.
Measured: In total 9 months, 3 months for each bicycle type.
Secondary outcomes (4)
Physical activity level
Change in total time of MVPA.
Measured: 2 weeks; one week at baseline, and one week after 9 months (post-intervention).
Cardiorespiratory fitness
Change in VO2 max.
Measured: Baseline and 9 months (post-intervention).
Body composition
Change in body composition.
Measured: Baseline and 9 months (post-intervention).
Blood pressure
Change in blood pressure.
Measured: Baseline and 9 months (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start2 Jun 2017
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
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 Bicycling DistanceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants in the intervention group (n=18) will complete the following intervention arms in random order: (i) 3 months access to an e-bicycle with trailer (n=6), (ii) 3 months access to a longtail bicycle (n=6), and (iii) 3 months access to a regular bicycle with trailer (n=6), in total 9 months. Also, a control group (n=18) maintaining usual transportation and PA habits will be included.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Agder
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, The National Association for Public Health, Norway
- Responsible party
- Principal investigator, Helga Birgit Bjørnarå, University of Agder
- Investigators
- Elling Bere, Prof., Principal investigator, University of Agder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131518
- Sponsor's protocol ID
- 1320 98842
- Status last verified
- Jun 2018
- First submitted
- 19 Apr 2017
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjornara HB, Berntsen S, Te Velde SJ, Fegran L, Fyhri A, Deforche B, Andersen LB, Bere E. From cars to bikes - the feasibility and effect of using e-bikes, longtail bikes and traditional bikes for transportation among parents of children attending kindergarten: design of a randomized cross-over trial. BMC Public Health. 2017 Dec 28;17(1):981. doi: 10.1186/s12889-017-4995-z.
PubMed 29282108
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Cars to Bikes - the Feasibility and Effect of Using E-bikes, Traditional Bikes and Longtail Bikes for Transportation Among Parents of Children Attending Kindergarten: a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT03131518
- Acronym / sponsor ID
- 1320 98842
- Conditions
- Bicycling Distance, Bicycling Time, Physical Activity Level, Cardiorespratory Fitness, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AgderUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, The National Association for Public Health, Norway
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- 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.
There is a need for a greater understanding of e-bikes and their role in the transportation network, and further effects on physical activity (PA) levels and health. Moreover, longtail bikes could meet certain practical needs not sufficiently fulfilled by e-bikes or traditional bikes, hence increased knowledge regarding their potential and feasibility should be obtained. No intervention study has investigated whether providing an e-bike or a longtail bike over an extended period in a sample of inactive parents of toddlers influence objectively assessed amount of cycling, total PA level, potential mode shifts, and effect on cardiorespiratory fitness, body composition and blood pressure.
Objectives:
To assess the effect of an intervention where participants have access to an e-bike (including a trailer), a longtail bike and a traditional bike (including a trailer) on the following parameters:
- Objectively assessed amount of biking, total levels of PA, and mode shifts from car/motorized modes to bicycle.
- Cardiorespiratory fitness, blood pressure, body composition, self-reported health and health-related quality of life (HRQoL).
- Experiences with bicycling (el/longtail/traditional) and intrinsic motivation for bicycling.
- How season and weather conditions influence the amount of bicycling (el/longtail/traditional).
Study sample:
A convenience sample consisting of 36 inactive parents of toddlers will be recruited among residents in Kristiansand municipality, Southern Norway.
Measures:
The following measures will be conducted:
- A web-based questionnaire will assess socio-demographics (at baseline only), transportation habits, self-perceived health and HRQoL, and motivation for bicycling for transportation. For the intervention group: at baseline and post all intervention arms, i.e. four times. For the control group: at baseline and after 9 months, i.e. two times.
- Cycling time and distance will be assessed through usage of a cycle computer throughout the entire project period, in total nine months.
- Time spent in moderate-to-vigorous PA (MVPA) will be estimated with the monitor SenseWear Armband Mini (SWA) for seven consecutive days at study start and after 9 months (post-intervention).
- Cardiorespiratory fitness will be measured performing treadmill walking/running, and dual-energy X-ray absorptiometry (DXA) will be used for assessing body composition. In addition, blood pressure, body weight and height (height only at baseline) will be measured at baseline and after 9 months (post-intervention).
- Participants' experiences with and motivation for usage of the different bicycle types will be explored in semi-structured focus group interviews after 3 months, 6 months and 9 months.
- Weather data (temperature, rainfall, snow, etc.) will also be collected.
Scientific contribution:
The present study will add knowledge to relevant and topical areas, i.e. issues related to public health and environmental sustainability, among parents of toddlers, representing an important target group.There is a call for research on the influence of e-bikes on travel behavior and level of MVPA, and whether voluntary cycling with e-bikes could improve health. Moreover, to our knowledge no scientific studies have assessed possible effects of using a longtail bike, on the selected parameters. If the current study reveals promising results, it should be replicated in a larger and more representative sample of parents of toddlers, as well as in other important target groups (e.g. older adults). If findings are positive, inclusion in national public health policies should be considered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants in the intervention group (n=18) will complete the following intervention arms in random order: (i) 3 months access to an e-bicycle with trailer (n=6), (ii) 3 months access to a longtail bicycle (n=6), and (iii) 3 months access to a regular bicycle with trailer (n=6), in total 9 months. Also, a control group (n=18) maintaining usual transportation and PA habits will be included.
| Arm | Type | Receives |
|---|---|---|
| E-bicycle | Other | Behavioral: Access to an e-bicycle with trailerAccess to an e-bicycle will be provided. |
| Longtail bicycle | Other | Behavioral: Access to a longtail bicycleAccess to a longtail bicycle will be provided. |
| Traditional bicycle | Other | Behavioral: Access to a traditional bike with trailerAccess to a traditional bicycle will be provided. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- being able to understand and read Norwegian
- having one child born in 2013, 2014 or 2015 attending kindergarten
- being responsible for bringing/picking up the "study child" in the kindergarten ≥5 times per week/at least half of the times
- residing 2-10 km from the workplace
- residing <3 km from the kindergarten and the grocery shop
Key exclusion criteria (2 listed)
- having bicycled more than once weekly during the last 12 months to either the workplace, the kindergarten, or the grocery shop.
- suffering from severe cardiovascular diseases or upper respiratory tract diseases.
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 |
|---|---|---|
| Access to an e-bicycle with trailerParticipants will be provided with an e-bike with trailer for 3 months. | Behavioural | E-bicycle |
| Access to a longtail bicycleParticipants will be provided with a longtail bike for 3 months. | Behavioural | Longtail bicycle |
| Access to a traditional bike with trailerParticipants will be provided with a traditional bicycle with trailer for 3 months. | Behavioural | Traditional bicycle |
Primary outcome
Amount of bicycling
Time frame: In total 9 months, 3 months for each bicycle type.
Bicycling distance and time will be combined to assess change in total amount of bicycling for transportation.
4 secondary outcomes
Physical activity level
Time frame: 2 weeks; one week at baseline, and one week after 9 months (post-intervention).
Cardiorespiratory fitness
Time frame: Baseline and 9 months (post-intervention).
Body composition
Time frame: Baseline and 9 months (post-intervention).
Blood pressure
Time frame: Baseline and 9 months (post-intervention).
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 29 Jun 2018.
- Derived from this study: PubMed 29282108Bjornara HB, Berntsen S, Te Velde SJ, Fegran L, Fyhri A, Deforche B, Andersen LB, Bere E. From cars to bikes - the feasibility and effect of using e-bikes, longtail bikes and traditional bikes for transportation among parents of children attending kindergarten: design of a randomized cross-over trial. BMC Public Health. 2017 Dec 28;17(1):981. doi: 10.1186/s12889-017-4995-z.
- Individual participant dataSharing planned: No
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.
Elling Bere, Prof. principal investigator
University of Agder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to an e-bicycle with trailer, Access to a longtail bicycle and Access to a traditional bike with trailer in people with Bicycling Distance and Bicycling Time, run by University of Agder at 1 site in Norway.
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 9 inclusion and 2 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Amount of bicycling (time frame: In total 9 months, 3 months for each bicycle type.). 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 NCT03131518, 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 29 Jun 2018.