NCT01236222

Brief Summary

The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

3 months

First QC Date

November 4, 2010

Last Update Submit

August 8, 2011

Conditions

Keywords

commuter cyclingfitnessmetabolic syndromechildren

Outcome Measures

Primary Outcomes (1)

  • Fitness

    Difference in VO2max determined by use of a metabolic cart

    Day 0, Day 120

Secondary Outcomes (1)

  • Metabolic syndrome

    Day 0, Day 120

Study Arms (2)

Control group

NO INTERVENTION

Cycling to school

EXPERIMENTAL
Behavioral: Cycling to school

Interventions

Regular cycling to school

Cycling to school

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • passive commuted to school last 6 months, own a bike

You may not qualify if:

  • less than 2 km to school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Denmark, 5230, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 8, 2010

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations