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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014