REGULarity of Physical ActivitieS (REGUL'APS)

Sponsor

University of Nancy (Other)

Overall Status

Completed

CT.gov ID

NCT01161212

Collaborator

IVRSP: Institut Virtuel de Recherche en Santé Publique (Other)

1,600

Enrollment

Location

Arms

Duration (Months)

133.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Other: Physical education sessions Other: Physical education sessions	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: Control group	Other: Physical education sessions 1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)
Other: Intervention group	Other: Physical education sessions 3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions

Arm

Intervention/Treatment

Other: Control group

Other: Physical education sessions

1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)

Other: Intervention group

Other: Physical education sessions

3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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