PreventionNCT01236222
Health Effects of Commuter Cycling
A study testing Cycling to school in people with Prevention, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- Cycling to school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- passive commuted to school last 6 months, own a bike
Who cannot join
- less than 2 km to school
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.
Read the detailed description
Physical activity plays a crucial role in relation to prevent a clustering of risk factors. In adults a lower all-cause mortality has been found in those cycling to work compared to inactive commuters. It thus seems possible that cycling to school will entail health beneficial effects for children.
- Conditions
- Prevention
- Being tested
- Cycling to school
- Keywords
- commuter cycling, fitness, metabolic syndrome, children
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling to schoolBehavioural
Regular cycling to school
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Cycling to school | Experimental | Not described Receives: Behavioral: Cycling to school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness
Difference in VO2max determined by use of a metabolic cart
Measured: Day 0, Day 120
Secondary outcomes (1)
Metabolic syndrome
Metabolic syndrome as defined by the international diabetes federation based upon: obesity(from age and gender adjusted BMI),TG,HDL,blood pressure,glucose (fasting)
Measured: Day 0, Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236222
- Sponsor's protocol ID
- Cycling
- Status last verified
- Aug 2011
- First submitted
- 4 Nov 2010
- Last updated
- 9 Aug 2011
- Results posted
- No
Publications
Ostergaard L, Borrestad LA, Tarp J, Andersen LB. Bicycling to school improves the cardiometabolic risk factor profile: a randomised controlled trial. BMJ Open. 2012 Oct 31;2(6):e001307. doi: 10.1136/bmjopen-2012-001307. Print 2012.
PubMed 23117560
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Commuter Cycling
- ClinicalTrials.gov ID
- NCT01236222
- Acronym / sponsor ID
- Cycling
- Conditions
- Prevention
- Keywords
- commuter cycling, fitness, metabolic syndrome, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.
Detailed description
Physical activity plays a crucial role in relation to prevent a clustering of risk factors. In adults a lower all-cause mortality has been found in those cycling to work compared to inactive commuters. It thus seems possible that cycling to school will entail health beneficial effects for children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Cycling to school | Experimental | Behavioral: Cycling to school |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- passive commuted to school last 6 months, own a bike
Key exclusion criteria (1 listed)
- less than 2 km to school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling to schoolRegular cycling to school | Behavioural | Cycling to school |
Primary outcome
Fitness
Time frame: Day 0, Day 120
Difference in VO2max determined by use of a metabolic cart
1 secondary outcome
Metabolic syndrome
Time frame: Day 0, Day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
- Derived from this study: PubMed 23117560Ostergaard L, Borrestad LA, Tarp J, Andersen LB. Bicycling to school improves the cardiometabolic risk factor profile: a randomised controlled trial. BMJ Open. 2012 Oct 31;2(6):e001307. doi: 10.1136/bmjopen-2012-001307. Print 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling to school in people with Prevention, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness (time frame: Day 0, Day 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.