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

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ClinicalTrials.gov Identifier: NCT01161212
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : July 26, 2010
Information provided by:

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment
Overweight Obesity Other: Physical education sessions

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren
Study Start Date : September 2005
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161212

Public health School, Laboratory EA4360 Apemac
Vandoeuvre-Lès-Nancy, France, 54505
Sponsors and Collaborators
University of Nancy
IVRSP: Institut Virtuel de Recherche en Santé Publique
Principal Investigator: Anne Vuillemin, PhD Public Health School, Laboratory EA4360 Apemac
More Information

Responsible Party: Anne Vuillemin, PhD, Public Health School, Laboratory EA4360 Apemac
ClinicalTrials.gov Identifier: NCT01161212     History of Changes
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 )
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010

Keywords provided by University of Nancy:
body mass index
health-related quality of life
physical education
cluster randomized controlled trial

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms