Body Composition Clinical Trial
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
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 |
Verified date | June 2018 |
Source | University of Agder |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Norway | University of Agder | Kristiansand |
Lead Sponsor | Collaborator |
---|---|
University of Agder | Nasjonalforeningen for folkehelsen, Stiftelsen Helse og Rehabilitering |
Norway,
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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