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Completed

NCT Number: NCT01161212

REGULarity of Physical ActivitieS (REGUL'APS)

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

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public health School, Laboratory EA4360 Apemac

Vandœuvre-lès-Nancy, 54505, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical education sessions

Other

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

Primary outcomes

  1. Body mass index (BMI) and waist circumference

    Time frame: 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 outcomes

  1. Health-related quality of life

    Time frame: September 2006 and June 2007

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

Sponsors and collaborators

Lead sponsor

University of Nancy

Other

Collaborators

  • IVRSP: Institut Virtuel de Recherche en Santé Publique

Registry information

Official study title

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

Acronym: REGUL'APS

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 13, 2010
Registry last updated
Jul 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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