Viewing Study NCT01161212


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Study NCT ID: NCT01161212
Status: COMPLETED
Last Update Posted: 2010-07-26
First Post: 2010-07-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: REGULarity of Physical ActivitieS (REGUL'APS)
Sponsor: University of Nancy
Organization:

Study Overview

Official Title: Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren
Status: COMPLETED
Status Verified Date: 2010-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: REGUL'APS
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: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
CNIL n°05-1340 OTHER French Data Protection Authority View
CCTIRS-05.65 OTHER National Consultative Ethics Committee for Health and Life Sciences View