NCT06381687

Brief Summary

The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 15, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Early ChildhoodMovement behaviorsGross and fine motor skills

Outcome Measures

Primary Outcomes (5)

  • Physical activity

    Accelerometry (Actigraph model) will be used to objectively assess physical activity. Children will wear an accelerometer for one week (weekend included) during ECEC hours. Accelerometer data will be downloaded and converted to 15-s epoch files using ActiLife software (version 6.4, ActiGraph Inc, Pensacola, FL, USA).

    At baseline and 12 months

  • Sleep time

    Sleep time wil be measured by parental report.

    At baseline and 12 months

  • Motor skills

    Participants' motor skills will be assessed using the Peabody Developmental Motor Scales, 3rd edition. The PDMS-3 is a standardized instrument to assess both gross and fine motor skills.

    At baseline and 12 months

  • Musical skills

    Musical skills will be assessed using a observational approach based on the five fundamental musical processes (listening, singing, instrumental interpretation, improvisation/composition and movement).

    At baseline and 12 months

  • Sedentary time

    Accelerometry (Actigraph model) will be used to objectively assess sedentary time. Children will wear an accelerometer for one week (weekend included) during ECEC hours. Accelerometer data will be downloaded and converted to 15-s epoch files using ActiLife software (version 6.4, ActiGraph Inc, Pensacola, FL, USA).

    At baseline and 12 months

Secondary Outcomes (9)

  • For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities.

    At baseline and 12 months

  • For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play.

    At baseline and 12 months

  • For ECEC educators, the first secondary outcome will be the perceived barriers and facilitators for the inclusion of movement and music as curricular practices in the ECEC institution.

    At baseline and 12 months

  • For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program.

    At baseline and 12 months

  • For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children.

    At baseline and 12 months

  • +4 more secondary outcomes

Study Arms (2)

Experimental intervention: characteristics of the movement and music programme

EXPERIMENTAL

A multi-component, multi-level programme (MoviMusi) will be designed and implemented in each city by the 12 ECEC centres in the intervention group. The intervention programme will start after baseline measurements and it will be implemented during 12 months. Accompanied by members of the intervention team, the educational community will be empowered to identify areas for improvement and make the necessary changes in their centres. In addition, the intervention programme will aim to address the main barriers and facilitators identified during the first year (baseline assessment) in relation to movement and music curricular practices.

Behavioral: A multi-component, multi-level programme (MoviMusi)

Control group

NO INTERVENTION

In the three cities, 12 ECEC institutions will participate in the control group. The centres will follow their usual curricular programme and will be visited to identify the curricular movement and music practices they are implementing, to assess the quality of the school environment and to measure PA, gross and fine motor skills, and music skills at baseline and at the end of the study.

Interventions

The MoviMusi program will be designed and implemented in each city by the 12 ECEC centres in the intervention group. In addition, the intervention programme will aim to address the main barriers and facilitators identified during the first year (baseline assessment) in relation to movement and music curricular practices. The programme will have three axes: (1) Training. Educators and families will actively participate in a series of seminars and training workshops on the promotion of PA as a healthy behaviour and the use of music as a didactic resource to strengthen holistic education both inside and outside ECEC. (2) Participation. Each ECEC institution will be supported as they design a movement and music programme to offer children better opportunities to learn about the body, its possibilities of action, and musical skills.(3) Implementation. The specific actions of the MoviMusi Programme will be put into practice in each ECEC institution.

Experimental intervention: characteristics of the movement and music programme

Eligibility Criteria

Age14 Months - 22 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Young children aged 14 to 22 months.
  • Regularly attending the Early Childhood Education and Care centre.
  • Parents giving informed consent.

You may not qualify if:

  • Young children not attending more than two days to centre.
  • Young children attending only half part of the day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, Valencia, 46021, Spain

RECRUITING

Related Publications (3)

  • undefined

    BACKGROUND
  • Gubbels JS, Van Kann DHH, Cardon G, Kremers SPJ. Activating Childcare Environments for All Children: the Importance of Children's Individual Needs. Int J Environ Res Public Health. 2018 Jul 3;15(7):1400. doi: 10.3390/ijerph15071400.

    PMID: 29970831BACKGROUND
  • Carson V, Draper CE, Okely A, Reilly JJ, Tremblay MS. Future Directions for Movement Behavior Research in the Early Years. J Phys Act Health. 2023 Dec 18;21(3):218-221. doi: 10.1123/jpah.2023-0679. Print 2024 Mar 1. No abstract available.

    PMID: 38109880BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Vladimir E University of Valencia, Ph.D.

CONTACT

María del Mar Bernabé-Villodre, Ph. D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The allocation of ECECs to the intervention versus control group will be randomised in a blinded procedure at the end of the first year, following the baseline assessment. Once ECEC centres meeting the selection criteria are identified, they will be randomised to one of the trial arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 24, 2024

Study Start

March 20, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2025

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

The Spanish government has given us a grant without taking into account this policy.

Locations