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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
History of Changes
  Purpose

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 Intervention
Overweight
Obesity
 Other: Physical education sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Nancy:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 1600
Study Start Date: September 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161212

Locations
France
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
Investigators
Principal Investigator: Anne Vuillemin, PhD Public Health School, Laboratory EA4360 Apemac
  More Information

No publications provided

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, CCTIRS-05.65
Study First Received: July 9, 2010
Last Updated: July 23, 2010
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: French Data Protection Authority

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

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013