ClinicalTrials.gg
CompletedNCT03454061Updated Mar 5, 2018

Effects of a Physical Education Programme in Preschool Children

An interventional study of physical activity in Motor Activity and Child Development, sponsored by University of Palermo. Completed. Open to participants aged 40 Months to 67 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by University of Palermo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Dec 2015, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
119
Allocation
Non-randomized
Ages
40 Months to 67 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Motor Activity
  • Child Development

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Keywords

  • sport
  • physical activity
  • education
  • fundamental motor skills
  • childhood
  • exercise
  • health
  • training
  • intervention
  • gross motor development
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 119 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Palermo is the lead sponsor of 145 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Months to 67 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • preschool children

Exclusion criteria

Exclusion Criteria:

  • Age \< 40 months
  • Age > 67 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
119 participants (actual)

Study arms

  • Experimental
    Intervention

    Physical activity intervention

    Other: physical activity

  • No intervention
    Control

    Keep usual activities in kindergarten

Interventions

  • Otherphysical activity

    Physical education program (PEP) of 16-week length

06

What researchers measure

Primary outcomes

  1. Quotient of gross motor development change

    Quotient of gross motor development

    Time frame: Change from Baseline at 16 weeks

Secondary outcomes

  1. BMI

    Body mass index

    Time frame: Change from Baseline at 16 weeks

  2. Weight

    Weight

    Time frame: Change from Baseline at 16 weeks

  3. Height

    Height

    Time frame: Change from Baseline at 16 weeks

  4. Object control skills change

    Object control

    Time frame: Change from Baseline at 16 weeks

  5. Locomotion skills change

    locomotion

    Time frame: Change from Baseline at 16 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31474231 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2015 to primary completion in May 2016, 5 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 5 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2018
First posted
Mar 5, 2018
StartActual
Dec 2015
Primary completionActual
May 31, 2016
CompletionActual
Jun 2016
Last update
Mar 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03454061
Responsible party
Giuseppe Battaglia (PhD, University of Palermo) — Principal investigator
First posted
Mar 5, 2018
Start date
Dec 2015
Primary completion
May 31, 2016
Completion
Jun 2016
Last update
Mar 5, 2018

Study contacts

Marianna Bellafiore
study director · University of Palermo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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