- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06381687
A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol) (MOVIMUSI)
A Movement and Music Programme in Early Childhood Education and Care to Promote Physical Activity, Gross and Fine Motor and Musical Skills: The MoviMusi Study Protocol
Study Overview
Status
Intervention / Treatment
Detailed Description
ECEC settings are important determinants of children´s behaviour. Ecological models help to contextualise and explain how the different environments in which children interact on a daily basis (school, home, and peer relations) have the capacity to influence childrens development. 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. A pending line of research is the identification of the key correlates of changes in movement behaviour throughout the early years, which would generate knowledge crucial to developing policy interventions that promote general wellbeing in young children. Thus, this study focuses on the importance of home and ECEC settings in the development of movement behaviour through a critical analysis of how curricular practices can be more effective in influencing childrens holistic development.
Aims 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.
Hypotheses The research set out to test the following hypotheses: 1. Girls and boys (1-2 years) will perform the same amount of PA during the school day. 2. The implementation of a music and movement intervention programme will increase children´s PA during the school day. 3. The music and movement intervention programme will have an impact on higher levels of childrens GMS as well as a variety of musical processes in the intervention group. 4. The ECEC community will be actively involved in the co-creation process of the movement and music intervention programme.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vladimir E University of Valencia, Ph.D.
- Phone Number: 25473 +34961625473
- Email: vladimir.martinez@uv.es
Study Contact Backup
- Name: María del Mar Bernabé-Villodre, Ph. D.
- Phone Number: 34961683180
- Email: maria.mar.bernabe@uv.es
Study Locations
-
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain, 46021
- Recruiting
- University of Valencia
-
Contact:
- Vladimir Martínez-Bello, Ph.D.
- Phone Number: 34961625473
- Email: vladimir.martinez@uv.es
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Principal Investigator:
- María del Mar Bernabé-Villodre, Ph.D.
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Sub-Investigator:
- Herminia Vega-Perona, Ms.Sc.
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Sub-Investigator:
- José Díaz-Barahona, Ph.D.
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Sub-Investigator:
- Yolanda Cabrera García-Ochoa, Ph.D.
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Sub-Investigator:
- Sandra Molines-Borrás, Ph.D.
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Sub-Investigator:
- Felipe Gertrudix, Ph. D.
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Sub-Investigator:
- Juan Carlos Montoya-Rubio, Ph. D.
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Sub-Investigator:
- María Ángeles Fernández-Vilar, Ph. D.
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Sub-Investigator:
- José Manuel Azorín, Ph. D.
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Sub-Investigator:
- Nataliya Filenko, Ph. D.
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Sub-Investigator:
- Daniel Martínez-Bello, Ph.D.
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Sub-Investigator:
- Ángela Martínez, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Young children aged 14 to 22 months.
- Regularly attending the Early Childhood Education and Care centre.
- Parents giving informed consent.
Exclusion Criteria:
- Young children not attending more than two days to centre.
- Young children attending only half part of the day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental intervention: characteristics of the movement and music programme
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.
|
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. |
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: At baseline and 12 months
|
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
Time Frame: At baseline and 12 months
|
Sleep time wil be measured by parental report.
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At baseline and 12 months
|
|
Motor skills
Time Frame: At baseline and 12 months
|
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.
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At baseline and 12 months
|
|
Musical skills
Time Frame: At baseline and 12 months
|
Musical skills will be assessed using a observational approach based on the five fundamental musical processes (listening, singing, instrumental interpretation, improvisation/composition and movement).
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At baseline and 12 months
|
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Sedentary time
Time Frame: At baseline and 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities.
Time Frame: At baseline and 12 months
|
Accelerometry (Actigraph model) will be used to objectively assess sedentary time.
Children will wear an accelerometer 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.
Time Frame: At baseline and 12 months
|
The OSRAC-P is a direct observation system designed to collect information about children's physical activity and the contextual circumstances surrounding it (Brown et al., 2006).
|
At baseline and 12 months
|
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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.
Time Frame: At baseline and 12 months
|
In each ECEC setting, educators will participate in focus groups to gather their perceptions about the place and purpose of movement and music practices in their classrooms.
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At baseline and 12 months
|
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For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program.
Time Frame: At baseline and 12 months
|
In each ECEC setting, educators will participate in focus groups, to gather their perceptions about the place and purpose of movement and music practices in their classrooms.
|
At baseline and 12 months
|
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For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children.
Time Frame: At baseline and 12 months
|
Barriers to active commuting will be assessed using an adapted version of the BATACE scale (BArreras en el Transporte Activo al Centro Educativo in Spanish, translated as: barriers to active transport to educational centres) for preschool and toddler parents.
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At baseline and 12 months
|
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For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home.
Time Frame: At baseline and 12 months
|
In each ECEC setting, families will participate in focus groups, in order to identify their perceptions of barriers and facilitators to movement and music practice outside of school hours.
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At baseline and 12 months
|
|
For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm
Time Frame: At baseline and 12 months
|
The modes of transport used for commuting to and from the ECEC centre will be evaluated through a questionnaire.
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At baseline and 12 months
|
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For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment.
Time Frame: At baseline and 12 months
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The Preschool-aged Children's PA Questionnaire (Pre-PAQ) is a questionnaire designed to measure habitual PA and sedentary behaviour in the child's home environment.
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At baseline and 12 months
|
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For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children.
Time Frame: At baseline and 12 months
|
Barriers to active commuting will be identified also by a qualitative analysis in focus groups.
|
At baseline and 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- undefined
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-3118978
- PID2022-141095NB-I00 (Other Grant/Funding Number: Spanish Ministry of Science, Innovation and Universities)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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