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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03131518
Other study ID # 1320 98842
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2017
Est. completion date June 25, 2018

Study information

Verified date June 2018
Source University of Agder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 25, 2018
Est. primary completion date June 25, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility 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 Design


Intervention

Behavioral:
Access to an e-bicycle with trailer
Participants will be provided with an e-bike with trailer for 3 months.
Access to a longtail bicycle
Participants will be provided with a longtail bike for 3 months.
Access to a traditional bike with trailer
Participants will be provided with a traditional bicycle with trailer for 3 months.

Locations

Country Name City State
Norway University of Agder Kristiansand

Sponsors (3)

Lead Sponsor Collaborator
University of Agder Nasjonalforeningen for folkehelsen, Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Feasibility and motivation for bicycling (qualitative) Experiences with bicycling for transportation, and changes in motivation for bicycling for transportation. Retrospective after 3 months, 6 months and 9 months (post-intervention).
Primary 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 Physical activity level Change in total time of MVPA. 2 weeks; one week at baseline, and one week after 9 months (post-intervention).
Secondary Cardiorespiratory fitness Change in VO2 max. Baseline and 9 months (post-intervention).
Secondary Body composition Change in body composition. Baseline and 9 months (post-intervention).
Secondary Blood pressure Change in blood pressure. Baseline and 9 months (post-intervention).
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