NCT03454061

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
Last Updated

March 5, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

February 7, 2018

Last Update Submit

February 26, 2018

Conditions

Keywords

sportphysical activityeducationfundamental motor skillschildhoodexercisehealthtraininginterventiongross motor development

Outcome Measures

Primary Outcomes (1)

  • Quotient of gross motor development change

    Quotient of gross motor development

    Change from Baseline at 16 weeks

Secondary Outcomes (5)

  • BMI

    Change from Baseline at 16 weeks

  • Weight

    Change from Baseline at 16 weeks

  • Height

    Change from Baseline at 16 weeks

  • Object control skills change

    Change from Baseline at 16 weeks

  • Locomotion skills change

    Change from Baseline at 16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Physical activity intervention

Other: physical activity

Control

NO INTERVENTION

Keep usual activities in kindergarten

Interventions

Physical education program (PEP) of 16-week length

Intervention

Eligibility Criteria

Age40 Months - 67 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • preschool children

You may not qualify if:

  • Age \< 40 months
  • Age \> 67 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marianna Bellafiore

    University of Palermo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 5, 2018

Study Start

December 1, 2015

Primary Completion

May 31, 2016

Study Completion

June 1, 2016

Last Updated

March 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share