Effects of a Physical Education Programme in Preschool Ch... | NCT03454061

Studies
Effects of a Physical Education Programme in Preschool Children

NCT03454061

Sponsor

University of Palermo

Status

Completed

Last Update Posted

Mar 5, 2018Actual

Enrollment

119Actual

Phase

Not Applicable

Conditions

Motor Activity
Child Development

Interventions

physical activity

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

May 31, 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 7, 2018

First Submission Date that Met QC Criteria

Feb 26, 2018

First Posted Date

Mar 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2018

Last Update Posted Date

Mar 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Physical activity intervention	Other: physical activity
Control	No Intervention	Keep usual activities in kindergarten

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical activity	Other	Physical education program (PEP) of 16-week length	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quotient of gross motor development change	Quotient of gross motor development	Change from Baseline at 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
BMI	Body mass index	Change from Baseline at 16 weeks
Weight	Weight	Change from Baseline at 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

preschool children

Exclusion Criteria:

Age < 40 months
Age > 67 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Months

Maximum Age

67 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Marianna Bellafiore	University of Palermo	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31474231	Derived	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.

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena