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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06381687
Other study ID # 2023-3118978
Secondary ID PID2022-141095NB
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2024
Est. completion date July 31, 2025

Study information

Verified date April 2024
Source University of Valencia
Contact Vladimir E University of Valencia, Ph.D.
Phone +34961625473
Email vladimir.martinez@uv.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

ECEC settings are important determinants of childrenĀ“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 childrenĀ“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.


Recruitment information / eligibility

Status Recruiting
Enrollment 312
Est. completion date July 31, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Months to 22 Months
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Spain University of Valencia Valencia Comunidad Valenciana

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Sleep time Sleep time wil be measured by parental report. At baseline and 12 months
Primary 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
Primary 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
Primary 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 For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities. 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
Secondary For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play. 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
Secondary 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. 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
Secondary For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program. 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
Secondary For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children. 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. At baseline and 12 months
Secondary For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home. 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. At baseline and 12 months
Secondary For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm The modes of transport used for commuting to and from the ECEC centre will be evaluated through a questionnaire. At baseline and 12 months
Secondary For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment. 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. At baseline and 12 months
Secondary For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children. Barriers to active commuting will be identified also by a qualitative analysis in focus groups. At baseline and 12 months
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