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REGULarity of Physical ActivitieS (REGUL'APS)

U

University of Nancy

Status

Completed

Conditions

Overweight
Obesity

Treatments

Other: Physical education sessions

Study type

Interventional

Funder types

Other

Identifiers

NCT01161212
CNIL n°05-1340 (Other Identifier)
Regulaps2006
CCTIRS-05.65 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

1,600 patients

Sex

All

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,600 participants in 2 patient groups

Control group
Other group
Treatment:
Other: Physical education sessions
Other: Physical education sessions
Intervention group
Other group
Treatment:
Other: Physical education sessions
Other: Physical education sessions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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