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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03454061
Other study ID # TH Project
Secondary ID
Status Completed
Phase N/A
First received February 7, 2018
Last updated February 26, 2018
Start date December 2015
Est. completion date June 2016

Study information

Verified date February 2018
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date June 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Months to 67 Months
Eligibility Inclusion Criteria

- preschool children

Exclusion Criteria:

- Age < 40 months

- Age > 67 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physical activity
Physical education program (PEP) of 16-week length

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Palermo

Outcome

Type Measure Description Time frame Safety issue
Primary Quotient of gross motor development change Quotient of gross motor development Change from Baseline at 16 weeks
Secondary BMI Body mass index Change from Baseline at 16 weeks
Secondary Weight Weight Change from Baseline at 16 weeks
Secondary Height Height Change from Baseline at 16 weeks
Secondary Object control skills change Object control Change from Baseline at 16 weeks
Secondary Locomotion skills change locomotion Change from Baseline at 16 weeks
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