NCT04714580

Brief Summary

The present literature supports the importance of the motor activity since the early stages of the human development. The children with poor motor skills are at greater risk for psychosocial, internalizing, and metabolic diseases. In Italy data about obesity and inactivity are increasing, anyway there is lack of motor program for pre-schoolers. The movement program Animal Fun seems to be a valid tool to support these children. The aim of this study is to verify the feasibility of using Animal Fun with Italian pre-schoolers. 119 preschool children (3-6 years old) from 3 Italian kindergartens were included in this study. The schools were randomly allocated to intervention and control group. Movement Assessment Battery for Children - 2 (MABC-2) was administered to all the children at the baseline and at one-month follow-up. During this month, the schools assigned to the control group followed the normal curriculum; the schools assigned to the Animal Fun group, followed the Animal Fun activity (thirty minutes, thrice a week). The investigators expect that the Animal Fun program demonstrates valid and feasible even in the Italian context, where there is lack of movement program supporting the development of the pre-school children.

Trial Health

87
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 Jan 2019

Geographic Reach
1 country

1 active site

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

January 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 7, 2021

Last Update Submit

January 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change form Baseline Movement Assessment Battery for Children-2 at 1 month follow-up

    This test is suitable for children and adolescents aged 3 to 17 years, and assesses the motor skills of children in the following domains: Aiming and Catching (AC), Balance (Bal), and Manual Dexterity (MD). Cluster and total standard scores for children are provided, with higher scores demonstrating better performance. A total test score (Tot MABC-2) at or below the 5th percentile indicates significant movement difficulty, while a score between the 5th and 15th percentile indicates that a child is "at risk". In these tests, the items and the scores were compared to the normative data of the uploaded version of the Italian MABC-2.

    One month

Study Arms (2)

Animal Fun Group

EXPERIMENTAL

Baseline assessment with MABC-2; Animal Fun activity with a certified trainer (physiotherapist) for one month, three times a week, for 30 minutes; one-month follow-up assessment with MABC-2.

Other: Animal Fun Program

Control Group

NO INTERVENTION

Baseline assessment with MABC-2; normal curricular activity at school with the teachers; one-month follow-up assessment with MABC-2.

Interventions

This program permits the operators to propose different activities, by following the needing of the children. As the name of this program suggests, all the activities involve an animal description, and ask the children to move like this animal, in a proper, correct and supervised way.

Animal Fun Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • parents written informed consent
  • attending one of the three involved kindergartens
  • years old.

You may not qualify if:

  • not-typically developing children
  • children with specific sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Trieste, Physiotherapy Degree

Trieste, 34100, Italy

Location

Related Publications (4)

  • Piek JP, Straker LM, Jensen L, Dender A, Barrett NC, McLaren S, Roberts C, Reid C, Rooney R, Packer T, Bradbury G, Elsley S. Rationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun"--a program designed to enhance physical and mental health in young children. BMC Pediatr. 2010 Nov 4;10:78. doi: 10.1186/1471-2431-10-78.

    PMID: 21050483BACKGROUND
  • Piek JP, Kane R, Rigoli D, McLaren S, Roberts CM, Rooney R, Jensen L, Dender A, Packer T, Straker L. Does the Animal Fun program improve social-emotional and behavioural outcomes in children aged 4-6 years? Hum Mov Sci. 2015 Oct;43:155-63. doi: 10.1016/j.humov.2015.08.004. Epub 2015 Aug 27.

    PMID: 26298689BACKGROUND
  • Piek JP, McLaren S, Kane R, Jensen L, Dender A, Roberts C, Rooney R, Packer T, Straker L. Does the Animal Fun program improve motor performance in children aged 4-6 years? Hum Mov Sci. 2013 Oct;32(5):1086-96. doi: 10.1016/j.humov.2012.08.004. Epub 2012 Nov 24.

    PMID: 23186610BACKGROUND
  • De Oliveira JA, Rigoli D, Kane R, McLaren S, Goulardins JB, Straker LM, Dender A, Rooney R, Piek JP. Does 'Animal Fun' improve aiming and catching, and balance skills in young children? Res Dev Disabil. 2019 Jan;84:122-130. doi: 10.1016/j.ridd.2018.07.004. Epub 2018 Aug 4.

    PMID: 30087016BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Francesca Policastro, PhD

    Univerisity of Trieste

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 19, 2021

Study Start

January 7, 2019

Primary Completion

June 30, 2019

Study Completion

January 31, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Each family will receive a summary of the results of assessment, in order to make them aware of the motor skills. Other researcher will be able to consult the complete results of the study and the study protocol.

Locations