From Cars to Bikes - the Feasibility and Effect of Bicycling for Transportation Among Parents of Toddlers

June 27, 2018 updated by: Helga Birgit Bjørnarå, University of Agder

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:

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:

  1. Objectively assessed amount of biking, total levels of PA, and mode shifts from car/motorized modes to bicycle.
  2. Cardiorespiratory fitness, blood pressure, body composition, self-reported health and health-related quality of life (HRQoL).
  3. Experiences with bicycling (el/longtail/traditional) and intrinsic motivation for bicycling.
  4. 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:

  1. 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.
  2. Cycling time and distance will be assessed through usage of a cycle computer throughout the entire project period, in total nine months.
  3. 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).
  4. 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).
  5. 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.
  6. 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway, 4604
        • University of Agder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • possessing a smartphone
  • being between 167-190 cm tall (due to the size of accessible bicycles)
  • having the opportunity to store the bicycles indoors

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: E-bicycle
Access to an e-bicycle will be provided.
Behavioral: Access to an e-bicycle with trailer
Participants will be provided with an e-bike with trailer for 3 months.
Other: Longtail bicycle
Access to a longtail bicycle will be provided.
Behavioral: Access to a longtail bicycle
Participants will be provided with a longtail bike for 3 months.
Other: Traditional bicycle
Access to a traditional bicycle will be provided.
Behavioral: Access to a traditional bike with trailer
Participants will be provided with a traditional bicycle with trailer for 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
In total 9 months, 3 months for each bicycle type.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity level
Time Frame: 2 weeks; one week at baseline, and one week after 9 months (post-intervention).
Change in total time of MVPA.
2 weeks; one week at baseline, and one week after 9 months (post-intervention).
Cardiorespiratory fitness
Time Frame: Baseline and 9 months (post-intervention).
Change in VO2 max.
Baseline and 9 months (post-intervention).
Body composition
Time Frame: Baseline and 9 months (post-intervention).
Change in body composition.
Baseline and 9 months (post-intervention).
Blood pressure
Time Frame: Baseline and 9 months (post-intervention).
Change in blood pressure.
Baseline and 9 months (post-intervention).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility and motivation for bicycling (qualitative)
Time Frame: Retrospective after 3 months, 6 months and 9 months (post-intervention).
Experiences with bicycling for transportation, and changes in motivation for bicycling for transportation.
Retrospective after 3 months, 6 months and 9 months (post-intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Agder

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stiftelsen Helse og Rehabilitering
Nasjonalforeningen for folkehelsen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elling Bere, Prof., University of Agder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1320 98842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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