REGULarity of Physical ActivitieS (REGUL'APS) (REGUL'APS)

July 23, 2010 updated by: University of Nancy

Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren

In French primary schools, children participate in 3 compulsory hours of physical education (PE) each week unless they have a medical contra-indication. But, there is no scientific evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of PE brings or not the same effects, particularly to prevent overweight or obesity.

Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed of a BMI increase and on health-related quality of life (HRQoL) over the school year.

Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-Lès-Nancy, France, 54505
        • Public health School, Laboratory EA4360 Apemac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All teachers under the cover of the headmasters in charge of classes from grades 2 to 5 in 2 counties in the Lorraine region of France (Meurthe-et-Moselle and Vosges [District of Golbey])
  • headmasters or teachers had to agree to modify the organisation of PE sessions

Exclusion Criteria:

  • Classes composed only of 2d grade
  • Set schedule of physical educational sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Other: Physical education sessions
3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions
Other: Physical education sessions
1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)
Other: Intervention group
Other: Physical education sessions
3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions
Other: Physical education sessions
1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI) and waist circumference
Time Frame: September 2006 and June 2007
September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)
September 2006 and June 2007

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: September 2006 and June 2007
September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)
September 2006 and June 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nancy

Collaborators

IVRSP: Institut Virtuel de Recherche en Santé Publique

Investigators

  • Principal Investigator: Anne Vuillemin, PhD, Public health School, Laboratory EA4360 Apemac

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Regulaps2006
  • CNIL n°05-1340 (Other Identifier: French Data Protection Authority)
  • CCTIRS-05.65 (Other Identifier: National Consultative Ethics Committee for Health and Life Sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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