Fundamental Motor SkillsMOVIMUSINCT06381687
A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol)
A study testing A multi-component, multi-level programme (MoviMusi) in people with Fundamental Motor Skills and Physical Activity, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 14 to 22 monthsHealthy volunteers can take part
- Conditions the study is for
- Fundamental Motor Skills, Physical Activity, Music Intervention
- What is being tested?
- A multi-component, multi-level programme (MoviMusi)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2024to 31 Jul 2025
- 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 14 to 22 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Young children aged 14 to 22 months.
- Regularly attending the Early Childhood Education and Care centre.
- Parents giving informed consent.
Who cannot join
- Young children not attending more than two days to centre.
- Young children attending only half part of the day.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, Valencia, 46021
Vladimir Martínez-Bello, Ph.D., 34961625473, vladimir.martinez@uv.es
María del Mar Bernabé-Villodre, Ph.D.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- A multi-component, multi-level programme (MoviMusi)
- Keywords
- Early Childhood, Movement behaviors, Gross and fine motor skills
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multi-component, multi-level programme (MoviMusi)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and 12 months
Sleep time
Sleep time wil be measured by parental report.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Accelerometry (Actigraph model) will be used to objectively assess sedentary time. Children will wear an accelerometer during unstructured and structured physical activity opportunities.
Measured: At baseline and 12 months
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: At baseline and 12 months
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.
Measured: At baseline and 12 months
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.
Measured: At baseline and 12 months
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.
Measured: At baseline and 12 months
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.
Measured: At baseline and 12 months
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.
Measured: At baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start20 Mar 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fundamental Motor SkillsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Martínez Bello, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381687
- Sponsor's protocol ID
- 2023-3118978
- Other IDs
- PID2022-141095NB-I00, 2023
- Acronym
- MOVIMUSI
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Spanish government has given us a grant without taking into account this policy.
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.
PubMed 29970831Carson 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.
PubMed 38109880
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06381687
- Acronym / sponsor ID
- MOVIMUSI / 2023-3118978
- Keywords
- Early Childhood, Movement behaviors, Gross and fine motor skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 24 Apr 2024 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention: characteristics of the movement and music programme | Experimental | Behavioral: A multi-component, multi-level programme (MoviMusi)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. |
| 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. |
Who may qualify
- Ages
- 14 to 22 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Young children aged 14 to 22 months.
- Regularly attending the Early Childhood Education and Care centre.
- Parents giving informed consent.
Key exclusion criteria (2 listed)
- Young children not attending more than two days to centre.
- Young children attending only half part of the day.
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 |
|---|---|---|
| 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. | Behavioural | Experimental intervention: characteristics of the movement and music programme |
Primary outcome
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).
Sleep time
Time frame: At baseline and 12 months
Sleep time wil be measured by parental report.
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.
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).
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).
9 secondary outcomes
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
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
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
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
For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children.
Time frame: At baseline and 12 months
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
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
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
For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children.
Time frame: At baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Backgroundundefined
- Background: PubMed 29970831Gubbels 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.
- Background: PubMed 38109880Carson 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.
- Individual participant dataSharing planned: No. The Spanish government has given us a grant without taking into account this policy.
Related trials for Fundamental Motor Skills
Not yet recruiting
School-based Active Play Intervention to Facilitate Movement Behaviours and Fundamental Movement Skills in Primary School Children of Bangladesh
Physical Activities, Sedentary Behaviors
Recruiting
Active Fundament - Fundamentally Better
Physical Inactivity in Early Childhood and Care, Delayed Fundamental Motor Skill Development
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multi-component, multi-level programme (MoviMusi) in people with Fundamental Motor Skills and Physical Activity, run by University of Valencia at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir E University of Valencia, Ph.D. (+34961625473 ext. 25473, vladimir.martinez@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: At baseline and 12 months). The study lists 5 primary outcomes in all. 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 NCT06381687, which also lists 3 linked publications.
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 24 Apr 2024.