REGULarity of Physical ActivitieS (REGUL'APS)

Obesity Clinical Trial

— REGUL'APS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161212
• Other study ID #: Regulaps2006
• Secondary ID: CNIL n°05-1340CC
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: July 23, 2010
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: July 2010
• Source: University of Nancy
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Physical education sessions
3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions
• Physical education sessions
1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)

Locations

Country	Name	City	State
France	Public health School, Laboratory EA4360 Apemac	Vandoeuvre-Lès-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
University of Nancy	IVRSP: Institut Virtuel de Recherche en Santé Publique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI) and waist circumference	September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)	September 2006 and June 2007	No
Secondary	Health-related quality of life	September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)	September 2006 and June 2007	No