Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-23', 'studyFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2010-07-12', 'lastUpdatePostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index (BMI) and waist circumference', 'timeFrame': 'September 2006 and June 2007', 'description': 'September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': 'September 2006 and June 2007', 'description': 'September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['body mass index', 'health-related quality of life', 'physical education', 'children', 'cluster randomized controlled trial', 'prevention', 'Child', 'French', 'Schoolchildren'], 'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': "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.\n\nRegul'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.\n\nStudy hypothesis: reduction of speed of increase of BMI and an increase of HRQoL"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\\])\n* headmasters or teachers had to agree to modify the organisation of PE sessions\n\nExclusion Criteria:\n\n* Classes composed only of 2d grade\n* Set schedule of physical educational sessions'}, 'identificationModule': {'nctId': 'NCT01161212', 'acronym': "REGUL'APS", 'briefTitle': "REGULarity of Physical ActivitieS (REGUL'APS)", 'organization': {'class': 'OTHER', 'fullName': 'University of Nancy'}, 'officialTitle': 'Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren', 'orgStudyIdInfo': {'id': 'Regulaps2006'}, 'secondaryIdInfos': [{'id': 'CNIL n°05-1340', 'type': 'OTHER', 'domain': 'French Data Protection Authority'}, {'id': 'CCTIRS-05.65', 'type': 'OTHER', 'domain': 'National Consultative Ethics Committee for Health and Life Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: Physical education sessions']}, {'type': 'OTHER', 'label': 'Intervention group', 'interventionNames': ['Other: Physical education sessions']}], 'interventions': [{'name': 'Physical education sessions', 'type': 'OTHER', 'description': '3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions', 'armGroupLabels': ['Intervention group']}, {'name': 'Physical education sessions', 'type': 'OTHER', 'description': '1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54505', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Public health School, Laboratory EA4360 Apemac', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Anne Vuillemin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health School, Laboratory EA4360 Apemac'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nancy', 'class': 'OTHER'}, 'collaborators': [{'name': 'IVRSP: Institut Virtuel de Recherche en Santé Publique', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Anne Vuillemin, PhD', 'oldOrganization': 'Public Health School, Laboratory EA4360 Apemac'}}}}