Clinical trial NCT03131518: From Cars to Bikes - the Feasibility and Effect of Bicycling for Transportation Among Parents of Toddlers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bicycling Distance
Bicycling Time
Physical Activity Level
Cardiorespratory Fitness
Body Composition
Lead sponsor: University of Agder
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
name: The National Association for Public Health, Norway
First posted: 2017-04-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Amount of bicycling
timeFrame: In total 9 months, 3 months for each bicycle type.
Secondary outcomes:
measure: Physical activity level
timeFrame: 2 weeks; one week at baseline, and one week after 9 months (post-intervention).
measure: Cardiorespiratory fitness
timeFrame: Baseline and 9 months (post-intervention).
measure: Body composition
timeFrame: Baseline and 9 months (post-intervention).
measure: Blood pressure
timeFrame: Baseline and 9 months (post-intervention).
Other outcomes:
measure: Feasibility and motivation for bicycling (qualitative)
timeFrame: Retrospective after 3 months, 6 months and 9 months (post-intervention).
Locations:
city: Kristiansand
country: Norway
facility: University of Agder
Study officials:
affiliation: University of Agder
name: Elling Bere, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.