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REGULarity of Physical ActivitieS (REGUL'APS) (REGUL'APS)

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Physical education sessions

About this trial

This is an interventional prevention trial for Overweight focused on measuring body mass index, health-related quality of life, physical education, children, cluster randomized controlled trial, prevention, Child, French, Schoolchildren

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Public health School, Laboratory EA4360 Apemac

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Control group

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Health-related quality of life

September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)

Full Information

NCT ID

NCT01161212

First Posted

July 9, 2010

Last Updated

July 23, 2010

Sponsor

University of Nancy

Collaborators

IVRSP: Institut Virtuel de Recherche en Santé Publique

1. Study Identification

Unique Protocol Identification Number

NCT01161212

Brief Title

REGULarity of Physical ActivitieS (REGUL'APS)

Acronym

REGUL'APS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Nancy

Collaborators

IVRSP: Institut Virtuel de Recherche en Santé Publique

4. Oversight

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

body mass index, health-related quality of life, physical education, children, cluster randomized controlled trial, prevention, Child, French, Schoolchildren

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Other

Arm Title

Intervention group

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Physical education sessions

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Physical education sessions

Intervention Description

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

Primary Outcome Measure Information:

Title

Body mass index (BMI) and waist circumference

Description

September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)

Time Frame

September 2006 and June 2007

Secondary Outcome Measure Information:

Title

Health-related quality of life

Description

September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)

Time Frame

September 2006 and June 2007

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Vuillemin, PhD

Organizational Affiliation

Public Health School, Laboratory EA4360 Apemac

Official's Role

Principal Investigator

Facility Information:

Facility Name

Public health School, Laboratory EA4360 Apemac

City

Vandoeuvre-Lès-Nancy

ZIP/Postal Code

54505

Country

France

12. IPD Sharing Statement

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REGULarity of Physical ActivitieS (REGUL'APS)

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