Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNIL n°05-1340 | Other Identifier | French Data Protection Authority | |
| CCTIRS-05.65 | Other Identifier | National Consultative Ethics Committee for Health and Life Sciences |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IVRSP: Institut Virtuel de Recherche en Santé Publique | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other |
| |
| Intervention group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical education sessions | Other | 3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later) | September 2006 and June 2007 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Vuillemin, PhD | Public Health School, Laboratory EA4360 Apemac | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public health School, Laboratory EA4360 Apemac | Vandœuvre-lès-Nancy | 54505 | France |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Physical education sessions | Other | 1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each) |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |