REGULarity of Physical ActivitieS (REGUL'APS)

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: Physical education sessions

• Registration Number: NCT01161212
• Lead Sponsor: University of Nancy

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2010-07
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Last Update Submitted: 2010-07-23
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Physical education sessions	-
Control group	Physical education sessions	-

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI) and waist circumference	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

Name	Time	Method
Health-related quality of life	September 2006 and June 2007	September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)

Trial Locations

Locations (1)

Public health School, Laboratory EA4360 Apemac; 🇫🇷 Vandoeuvre-Lès-Nancy, France