CClinicalTrials.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

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

Keywords

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

Who can participate

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

Inclusion criteria

  • preschool children

Exclusion criteria

Exclusion Criteria:

  • Age \< 40 months
  • Age > 67 months
04

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

05

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

06

Study locations

No study locations are listed for this record.

07

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

08

Registry details

Key details

Study ID
NCT03454061
Lead sponsor
University of Palermo
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 ↗

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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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