A cluster randomized controlled trial of the Archena Infancia Saludable project on 24-h movement behaviors and adherence to the mediterranean diet among schoolchildren: a pilot study protocol

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dc.contributor.authorLópez Gil, José Francisco
dc.contributor.authorGarcía Hermoso, Antonio
dc.contributor.authorSmith, Lee
dc.contributor.authorGallego, Alejandra
dc.contributor.authorVictoria-Montesinos, Desirée
dc.contributor.authorEzzatvar, Yasmin
dc.contributor.authorHershey, María Soledad
dc.contributor.authorGutiérrez Espinoza, Héctor
dc.contributor.authorMesas, Arthur
dc.contributor.authorJiménez-López, Estela
dc.contributor.authorSánchez-Miguel, Pedro Antonio
dc.contributor.authorLópez-Benavente, Alba
dc.contributor.authorMoreno Galarraga, Laura
dc.contributor.authorChen, Sitong
dc.contributor.authorBrazo-Sayavera, Javier
dc.contributor.authorFernández-Montero, Alejandro
dc.contributor.authorAlcaraz, Pedro E.
dc.contributor.authorPanisello Royo, Josefa María
dc.contributor.authorTárraga López, Pedro J.
dc.contributor.authorKales, Stefanos N.
dc.contributor.departmentCiencias de la Saludes_ES
dc.contributor.departmentOsasun Zientziakeu
dc.date.accessioned2023-07-28T15:51:57Z
dc.date.available2023-07-28T15:51:57Z
dc.date.issued2023
dc.date.updated2023-07-28T14:58:19Z
dc.description.abstractObjective: The aim of this paper is to describe the protocol of pilot cluster randomized controlled trial (RCT) that will evaluate the effects of a lifestyle-based intervention. The Archena Infancia Saludable project will have several objectives. The primary objective of this project is to determine the 6-month effects of a lifestyle-based intervention on adherence to 24-h movement behaviors and Mediterranean diet (MedDiet) in schoolchildren. The secondary objective of this project is to test the intervention effects of this lifestyle-based intervention on a relevant set of health-related outcomes (i.e., anthropometric measurements, blood pressure, perceived physical fitness, sleep habits, and academic performance). The tertiary objective is to investigate this intervention’s “halo” effect on parents’/guardians’ 24-h movement behaviors and adherence to the MedDiet. Methods: The Archena Infancia Saludable trial will be a cluster RCT submitted to the Clinical Trials Registry. The protocol will be developed according to SPIRIT guidelines for RCTs and CONSORT statement extension for cluster RCTs. A total of 153 eligible parents/guardians with schoolchildren aged 6–13 years will be randomized into an intervention group or a control group. This project focuses on two fundamental pillars: 24-h movement behaviors and MedDiet. It will mainly focus on the relationship between parents/guardians and their children. Behavior change strategies for dietary and 24-h movement behaviors in schoolchildren will be based on healthy lifestyle education for parents/guardians through infographics, video recipes, brief video clips, and videos. Conclusions: Most of the current knowledge on 24-h movement behaviors and adherence to the MedDiet is based on cross-sectional or longitudinal cohort studies, warranting a need to design and conduct RCTs to obtain more robust evidence on the effect of a healthy lifestyle program to increase 24-h movement behaviors and to improve adherence to the MedDiet in schoolchildren.en
dc.description.sponsorshipThis research will be funded by the Ayuntamiento de Archena (ID 25/2023).en
dc.format.mimetypeapplication/pdfen
dc.identifier.citationLópez-Gil, J. F., García-Hermoso, A., Smith, L., Gallego, A., Victoria-Montesinos, D., Ezzatvar, Y., Hershey, M. S., Gutiérrez-Espinoza, H., Mesas, A. E., Jiménez-López, E., Sánchez-Miguel, P. A., López-Benavente, A., Moreno-Galarraga, L., Chen, S., Brazo-Sayavera, J., Fernandez-Montero, A., Alcaraz, P. E., Panisello Royo, J. M., Tárraga-López, P. J., Kales, S. N. (2023) A cluster randomized controlled trial of the Archena Infancia Saludable project on 24-h movement behaviors and adherence to the mediterranean diet among schoolchildren: a pilot study protocol. Children, 10(4), 1-18. https://doi.org/10.3390/children10040738.en
dc.identifier.doi10.3390/children10040738
dc.identifier.issn2227-9067
dc.identifier.urihttps://academica-e.unavarra.es/handle/2454/45809
dc.language.isoengen
dc.publisherMDPIen
dc.relation.ispartofChildren 2023, 10(4), 738en
dc.relation.publisherversionhttps://doi.org/10.3390/children10040738
dc.rights© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.en
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectChildrenen
dc.subjectFamilyen
dc.subjectLifestyleen
dc.subjectMovement guidelinesen
dc.subjectMovement recommendationsen
dc.subjectParentsen
dc.subjectPhysical activityen
dc.subjectScreen timeen
dc.subjectSedentary behavioren
dc.subjectSleep durationen
dc.titleA cluster randomized controlled trial of the Archena Infancia Saludable project on 24-h movement behaviors and adherence to the mediterranean diet among schoolchildren: a pilot study protocolen
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dspace.entity.typePublication
relation.isAuthorOfPublicationa8a724dc-bd51-4ab2-8e46-97e362d3ba8f
relation.isAuthorOfPublicatione84ae68a-fa4a-4e00-be27-bedfffc8612e
relation.isAuthorOfPublicationcd85f9b5-fe76-479b-8881-2d15bf41cf53
relation.isAuthorOfPublication.latestForDiscoverycd85f9b5-fe76-479b-8881-2d15bf41cf53

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