Motor ActivityNCT03454061
Effects of a Physical Education Programme in Preschool Children
A study testing physical activity in people with Motor Activity and Child Development, run by University of Palermo.
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. Read more about this study
- Who is it for?
- Ages 40 to 67 monthsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Child Development
- What is being tested?
- physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 67 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preschool children
Who cannot join
- Age < 40 months
- Age > 67 months
About this study
Official title: 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.
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.
- Conditions
- Motor Activity, Child Development
- Being tested
- physical activity
- Keywords
- sport, physical activity, education, fundamental motor skills, childhood, exercise, health, training, intervention, gross motor development
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
Physical education program (PEP) of 16-week length
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Physical activity intervention Receives: Other: physical activity |
| Control | No intervention | Keep usual activities in kindergarten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quotient of gross motor development change
Quotient of gross motor development
Measured: Change from Baseline at 16 weeks
Secondary outcomes (5)
BMI
Body mass index
Measured: Change from Baseline at 16 weeks
Weight
Weight
Measured: Change from Baseline at 16 weeks
Height
Height
Measured: Change from Baseline at 16 weeks
Object control skills change
Object control
Measured: Change from Baseline at 16 weeks
Locomotion skills change
locomotion
Measured: Change from Baseline at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study startDec 2015
- Primary completion31 May 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Battaglia, University of Palermo
- Investigators
- Marianna Bellafiore, Study director, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454061
- Sponsor's protocol ID
- TH Project
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Motor Skills by a Physical Education Programme in Preschool Children: a Preschool-based Controlled Trial
- ClinicalTrials.gov ID
- NCT03454061
- Acronym / sponsor ID
- TH Project
- Conditions
- Motor Activity, Child Development
- Keywords
- sport, physical activity, education, fundamental motor skills, childhood, exercise, health, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: physical activityPhysical activity intervention |
| Control | No intervention | –Keep usual activities in kindergarten |
Who may qualify
- Ages
- 40 to 67 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschool children
Key exclusion criteria (2 listed)
- Age < 40 months
- Age > 67 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activityPhysical education program (PEP) of 16-week length | Other | Intervention |
Primary outcome
Quotient of gross motor development change
Time frame: Change from Baseline at 16 weeks
Quotient of gross motor development
5 secondary outcomes
BMI
Time frame: Change from Baseline at 16 weeks
Weight
Time frame: Change from Baseline at 16 weeks
Height
Time frame: Change from Baseline at 16 weeks
Object control skills change
Time frame: Change from Baseline at 16 weeks
Locomotion skills change
Time frame: Change from Baseline at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Derived from this study: PubMed 31474231Tabacchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna Bellafiore study director
University of Palermo
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Motor Activity and Child Development, run by University of Palermo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quotient of gross motor development change (time frame: Change from Baseline at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.