Effects of a Physical Education Programme in Preschool Children

February 26, 2018 updated by: Giuseppe Battaglia, University of Palermo

The Development of Motor Skills by a Physical Education Programme in Preschool Children: a Preschool-based Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • preschool children

Exclusion Criteria:

  • Age < 40 months
  • Age > 67 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Keep usual activities in kindergarten
Experimental: Intervention
Physical activity intervention
Other: physical activity
Physical education program (PEP) of 16-week length

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: Change from Baseline at 16 weeks
Body mass index
Change from Baseline at 16 weeks
Weight
Time Frame: Change from Baseline at 16 weeks
Weight
Change from Baseline at 16 weeks
Height
Time Frame: Change from Baseline at 16 weeks
Height
Change from Baseline at 16 weeks
Object control skills change
Time Frame: Change from Baseline at 16 weeks
Object control
Change from Baseline at 16 weeks
Locomotion skills change
Time Frame: Change from Baseline at 16 weeks
locomotion
Change from Baseline at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Study Director: Marianna Bellafiore, University of Palermo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TH Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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