protocolSection identificationModule nctId: NCT06381687, orgStudyIdInfo id: 2023-3118978, secondaryIdInfos id: PID2022-141095NB-I00, type: OTHER_GRANT, domain: Spanish Ministry of Science, Innovation and Universities, briefTitle: A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol), acronym: MOVIMUSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Fundamental Motor Skills, conditions: Physical Activity, conditions: Music Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: A multi-component, multi-level programme (MoviMusi), outcomesModule primaryOutcomes measure: Physical activity, primaryOutcomes measure: Sleep time, primaryOutcomes measure: Motor skills, primaryOutcomes measure: Musical skills, primaryOutcomes measure: Sedentary time, secondaryOutcomes measure: For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities., secondaryOutcomes measure: For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play., secondaryOutcomes measure: 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., secondaryOutcomes measure: For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program., secondaryOutcomes measure: For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children., secondaryOutcomes measure: For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home., secondaryOutcomes measure: For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm, secondaryOutcomes measure: For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment., secondaryOutcomes measure: For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children., eligibilityModule sex: ALL, minimumAge: 14 Months, maximumAge: 22 Months, stdAges: CHILD, contactsLocationsModule locations facility: University of Valencia, status: RECRUITING, city: Valencia, state: Comunidad Valenciana, zip: 46021, country: Spain, contacts name: Vladimir Martínez-Bello, Ph.D., role: CONTACT, phone: 34961625473, email: vladimir.martinez@uv.es, contacts name: María del Mar Bernabé-Villodre, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Herminia Vega-Perona, Ms.Sc., role: SUB_INVESTIGATOR, contacts name: José Díaz-Barahona, Ph.D., role: SUB_INVESTIGATOR, contacts name: Yolanda Cabrera García-Ochoa, Ph.D., role: SUB_INVESTIGATOR, contacts name: Sandra Molines-Borrás, Ph.D., role: SUB_INVESTIGATOR, contacts name: Felipe Gertrudix, Ph. D., role: SUB_INVESTIGATOR, contacts name: Juan Carlos Montoya-Rubio, Ph. D., role: SUB_INVESTIGATOR, contacts name: María Ángeles Fernández-Vilar, Ph. D., role: SUB_INVESTIGATOR, contacts name: José Manuel Azorín, Ph. D., role: SUB_INVESTIGATOR, contacts name: Nataliya Filenko, Ph. D., role: SUB_INVESTIGATOR, contacts name: Daniel Martínez-Bello, Ph.D., role: SUB_INVESTIGATOR, contacts name: Ángela Martínez, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False