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REGULarity of Physical ActivitieS (REGUL'APS)

This study has been completed.
Sponsor:
Collaborator:
IVRSP: Institut Virtuel de Recherche en Santé Publique
Information provided by:
University of Nancy
ClinicalTrials.gov Identifier:
NCT01161212
First received: July 9, 2010
Last updated: July 23, 2010
Last verified: July 2010

July 9, 2010
July 23, 2010
September 2005
September 2006   (final data collection date for primary outcome measure)
Body mass index (BMI) and waist circumference [ Time Frame: September 2006 and June 2007 ] [ Designated as safety issue: No ]
September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)
Same as current
Complete list of historical versions of study NCT01161212 on ClinicalTrials.gov Archive Site
Health-related quality of life [ Time Frame: September 2006 and June 2007 ] [ Designated as safety issue: No ]
September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)
Same as current
Not Provided
Not Provided
 
REGULarity of Physical ActivitieS (REGUL'APS)
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • 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)
  • Control group
    Intervention: Other: Physical education sessions
  • Intervention group
    Intervention: Other: Physical education sessions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1600
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01161212
Regulaps2006, CNIL n°05-1340, CCTIRS-05.65
Yes
Anne Vuillemin, PhD, Public Health School, Laboratory EA4360 Apemac
University of Nancy
IVRSP: Institut Virtuel de Recherche en Santé Publique
Principal Investigator: Anne Vuillemin, PhD Public Health School, Laboratory EA4360 Apemac
University of Nancy
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP