NCT03131518

Brief 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 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. 1.Objectively assessed amount of biking, total levels of PA, and mode shifts from car/motorized modes to bicycle.
  2. 2.Cardiorespiratory fitness, blood pressure, body composition, self-reported health and health-related quality of life (HRQoL).
  3. 3.Experiences with bicycling (el/longtail/traditional) and intrinsic motivation for bicycling.
  4. 4.How season and weather conditions influence the amount of bicycling (el/longtail/traditional).
  5. 5.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.
  6. 6.Cycling time and distance will be assessed through usage of a cycle computer throughout the entire project period, in total nine months.
  7. 7.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).
  8. 8.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).
  9. 9.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.
  10. 10.Weather data (temperature, rainfall, snow, etc.) will also be collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

April 19, 2017

Last Update Submit

June 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of bicycling

    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 Outcomes (4)

  • Physical activity level

    2 weeks; one week at baseline, and one week after 9 months (post-intervention).

  • Cardiorespiratory fitness

    Baseline and 9 months (post-intervention).

  • Body composition

    Baseline and 9 months (post-intervention).

  • Blood pressure

    Baseline and 9 months (post-intervention).

Other Outcomes (1)

  • Feasibility and motivation for bicycling (qualitative)

    Retrospective after 3 months, 6 months and 9 months (post-intervention).

Study Arms (3)

E-bicycle

OTHER

Access to an e-bicycle will be provided.

Behavioral: Access to an e-bicycle with trailer

Longtail bicycle

OTHER

Access to a longtail bicycle will be provided.

Behavioral: Access to a longtail bicycle

Traditional bicycle

OTHER

Access to a traditional bicycle will be provided.

Behavioral: Access to a traditional bike with trailer

Interventions

Participants will be provided with an e-bike with trailer for 3 months.

E-bicycle

Participants will be provided with a longtail bike for 3 months.

Longtail bicycle

Participants will be provided with a traditional bicycle with trailer for 3 months.

Traditional bicycle

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Agder

Kristiansand, 4604, Norway

Location

Related Publications (1)

  • 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.

Study Officials

  • Elling Bere, Prof.

    University of Agder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 27, 2017

Study Start

June 2, 2017

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations