Health Effects of Commuter Cycling

This study has been completed.

Sponsor:

Collaborator:

TrygFonden, Denmark

Information provided by:

University of Southern Denmark

ClinicalTrials.gov Identifier:

NCT01236222

First received: November 4, 2010

Last updated: August 8, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 4, 2010
Last Updated Date	August 8, 2011
Start Date ^ICMJE	March 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 8, 2011)	Fitness [ Time Frame: Day 0, Day 120 ] [ Designated as safety issue: No ] Difference in VO2max determined by use of a metabolic cart
Original Primary Outcome Measures ^ICMJE (submitted: November 5, 2010)	Fitness [ Time Frame: march (baseline) and june (endline) ] [ Designated as safety issue: No ] VO2max determined by use of a metabolic cart
Change History	Complete list of historical versions of study NCT01236222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 8, 2011)	Metabolic syndrome [ Time Frame: Day 0, Day 120 ] [ Designated as safety issue: No ] Metabolic syndrome as defined by the international diabetes federation based upon: obesity(from age and gender adjusted BMI),TG,HDL,blood pressure,glucose (fasting)
Original Secondary Outcome Measures ^ICMJE (submitted: November 5, 2010)	Metabolic syndrome [ Time Frame: march (baseline) and june (endline) ] [ Designated as safety issue: No ] obesity(from age and gender adjusted BMI),TG,HDL,blood pressure,glucose (fasting)
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Health Effects of Commuter Cycling
Official Title ^ICMJE	Health Effects of Commuter Cycling
Brief Summary	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 Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Prevention
Intervention ^ICMJE	Behavioral: Cycling to school Regular cycling to school
Study Arm (s)	No Intervention: Control group Experimental: Cycling to school Intervention: Behavioral: Cycling to school
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	60
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: passive commuted to school last 6 months, own a bike Exclusion Criteria: less than 2 km to school
Gender	Both
Ages	10 Years to 13 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01236222
Other Study ID Numbers ^ICMJE	Cycling
Has Data Monitoring Committee
Responsible Party	Lars Østergaard, University of Southern Denmark
Study Sponsor ^ICMJE	University of Southern Denmark
Collaborators ^ICMJE	TrygFonden, Denmark
Investigators ^ICMJE
Information Provided By	University of Southern Denmark
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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