REGULarity of Physical ActivitieS (REGUL'APS)
REGUL'APS
Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren
3 other identifiers
interventional
1,600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedJuly 26, 2010
July 1, 2010
1 year
July 9, 2010
July 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
September 2006 and June 2007
Secondary Outcomes (1)
Health-related quality of life
September 2006 and June 2007
Study Arms (2)
Control group
OTHERIntervention group
OTHERInterventions
3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Classes composed only of 2d grade
- Set schedule of physical educational sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public health School, Laboratory EA4360 Apemac
Vandœuvre-lès-Nancy, 54505, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Vuillemin, PhD
Public Health School, Laboratory EA4360 Apemac
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 9, 2010
First Posted
July 13, 2010
Study Start
September 1, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
July 26, 2010
Record last verified: 2010-07