Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-07 @ 5:12 PM
Study NCT ID:
NCT03454061
Status:
COMPLETED
Last Update Posted:
2018-03-05
First Post:
2018-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Physical Education Programme in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quotient of gross motor development change', 'timeFrame': 'Change from Baseline at 16 weeks', 'description': 'Quotient of gross motor development'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Change from Baseline at 16 weeks', 'description': 'Body mass index'}, {'measure': 'Weight', 'timeFrame': 'Change from Baseline at 16 weeks', 'description': 'Weight'}, {'measure': 'Height', 'timeFrame': 'Change from Baseline at 16 weeks', 'description': 'Height'}, {'measure': 'Object control skills change', 'timeFrame': 'Change from Baseline at 16 weeks', 'description': 'Object control'}, {'measure': 'Locomotion skills change', 'timeFrame': 'Change from Baseline at 16 weeks', 'description': 'locomotion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sport', 'physical activity', 'education', 'fundamental motor skills', 'childhood', 'exercise', 'health', 'training', 'intervention', 'gross motor development'], 'conditions': ['Motor Activity', 'Child Development']}, 'referencesModule': {'references': [{'pmid': '31474231', 'type': 'DERIVED', 'citation': 'Tabacchi G, Battaglia G, Alesi M, Paoli A, Palma A, Bellafiore M. Food literacy predictors and associations with physical and emergent literacy in pre-schoolers: results from the Training-to-Health Project. Public Health Nutr. 2020 Feb;23(2):356-365. doi: 10.1017/S1368980019002404. Epub 2019 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'Unlike other European countries, Italian kindergartens do not include the physical education teacher in the school organic personnel. This is frequently associated with the lack of opportunities to perform physical education by preschool children. The aim of this study was to analyse the effects of a specific 16-week-long physical education programme (PEP) of 16-week length on the development of locomotor and object control skills in preschool children.', 'detailedDescription': 'We conducted a school-based non-randomised controlled trial to evaluate the effect of a specific 16-week-long physical education program (PEP) on the quotient of gross motor development (QGMD) in preschool children. This study involved 119 children who were clustered in a control group (CG, n= 29, age: 52.1±8.65 months; height: 1.1±0.07 m, body weight: 19.2±5.55 Kg, BMI: 16.9±3.16) and an intervention group (IG, n= 90, age: 57.4±9.42 months; height: 1.1±0.06 m, body weight: 19.3±3.65 Kg, BMI: 16±1.75). Participants were assessed for locomotor ability and object control skills using the Italian version of gross motor development test, before and after the experimental period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '67 Months', 'minimumAge': '40 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* preschool children\n\nExclusion Criteria:\n\n* Age \\< 40 months\n* Age \\> 67 months'}, 'identificationModule': {'nctId': 'NCT03454061', 'briefTitle': 'Effects of a Physical Education Programme in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'The Development of Motor Skills by a Physical Education Programme in Preschool Children: a Preschool-based Controlled Trial', 'orgStudyIdInfo': {'id': 'TH Project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Physical activity intervention', 'interventionNames': ['Other: physical activity']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Keep usual activities in kindergarten'}], 'interventions': [{'name': 'physical activity', 'type': 'OTHER', 'description': 'Physical education program (PEP) of 16-week length', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marianna Bellafiore', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Palermo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Giuseppe Battaglia', 'investigatorAffiliation': 'University of Palermo'}}}}