OverweightREGUL'APSNCT01161212
REGULarity of Physical ActivitieS (REGUL'APS)
A study testing Physical education sessions in people with Overweight and Obesity, run by University of Nancy at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Physical education sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Classes composed only of 2d grade
- Set schedule of physical educational sessions
Trial locations and contacts
1 site in 1 country.
France1 site
Public health School, Laboratory EA4360 Apemac
Vandœuvre-lès-Nancy, 54505
About this study
Official title: Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren
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
- Conditions
- Overweight, Obesity
- Being tested
- Physical education sessions
- Keywords
- body mass index, health-related quality of life, physical education, children, cluster randomized controlled trial, prevention, Child, French, Schoolchildren
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical education sessionsOther
3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions
Physical education sessionsOther
1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Not described Receives: Other: Physical education sessions |
| Intervention group | Other | Not described Receives: Other: Physical education sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: September 2006 and June 2007
Secondary outcomes (1)
Health-related quality of life
September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)
Measured: September 2006 and June 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nancy
- Sponsor type
- University, hospital or other
- Collaborators
- IVRSP: Institut Virtuel de Recherche en Santé Publique
- Investigators
- Anne Vuillemin, PhD, Principal investigator, Public Health School, Laboratory EA4360 Apemac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161212
- Sponsor's protocol ID
- Regulaps2006
- Other IDs
- CNIL n°05-1340, CCTIRS-05.65
- Acronym
- REGUL'APS
- Status last verified
- Jul 2010
- First submitted
- 9 Jul 2010
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren
- ClinicalTrials.gov ID
- NCT01161212
- Acronym / sponsor ID
- REGUL'APS / Regulaps2006
- Conditions
- Overweight, Obesity
- Keywords
- body mass index, health-related quality of life, physical education, children, cluster randomized controlled trial, prevention, Child, French
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- University of NancyUniversity, hospital or other
- Collaborators
- IVRSP: Institut Virtuel de Recherche en Santé Publique
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Physical education sessions |
| Intervention group | Other | Other: Physical education sessions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Classes composed only of 2d grade
- Set schedule of physical educational sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical education sessions3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions | Other | Intervention group |
| Physical education sessions1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each) | Other | Control group |
Primary outcome
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)
1 secondary outcome
Health-related quality of life
Time frame: September 2006 and June 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Vuillemin, PhD principal investigator
Public Health School, Laboratory EA4360 Apemac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical education sessions in people with Overweight and Obesity, run by University of Nancy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) and waist circumference (time frame: September 2006 and June 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2010.