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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
Objective: 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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10137206/ https://www.ncbi.nlm.nih.gov/pubmed/37189987 http://dx.doi.org/10.3390/children10040738 |
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author | López-Gil, José Francisco García-Hermoso, Antonio Smith, Lee Gallego, Alejandra Victoria-Montesinos, Desirée Ezzatvar, Yasmin Hershey, Maria S. Gutiérrez-Espinoza, Héctor Mesas, Arthur Eumann Jiménez-López, Estela Sánchez-Miguel, Pedro Antonio López-Benavente, Alba Moreno-Galarraga, Laura Chen, Sitong Brazo-Sayavera, Javier Fernandez-Montero, Alejandro Alcaraz, Pedro Emilio Panisello Royo, Josefa María Tárraga-López, Pedro J. Kales, Stefanos N. |
author_facet | López-Gil, José Francisco García-Hermoso, Antonio Smith, Lee Gallego, Alejandra Victoria-Montesinos, Desirée Ezzatvar, Yasmin Hershey, Maria S. Gutiérrez-Espinoza, Héctor Mesas, Arthur Eumann Jiménez-López, Estela Sánchez-Miguel, Pedro Antonio López-Benavente, Alba Moreno-Galarraga, Laura Chen, Sitong Brazo-Sayavera, Javier Fernandez-Montero, Alejandro Alcaraz, Pedro Emilio Panisello Royo, Josefa María Tárraga-López, Pedro J. Kales, Stefanos N. |
author_sort | López-Gil, José Francisco |
collection | PubMed |
description | Objective: 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. |
format | Online Article Text |
id | pubmed-10137206 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-101372062023-04-28 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 López-Gil, José Francisco García-Hermoso, Antonio Smith, Lee Gallego, Alejandra Victoria-Montesinos, Desirée Ezzatvar, Yasmin Hershey, Maria S. Gutiérrez-Espinoza, Héctor Mesas, Arthur Eumann Jiménez-López, Estela Sánchez-Miguel, Pedro Antonio López-Benavente, Alba Moreno-Galarraga, Laura Chen, Sitong Brazo-Sayavera, Javier Fernandez-Montero, Alejandro Alcaraz, Pedro Emilio Panisello Royo, Josefa María Tárraga-López, Pedro J. Kales, Stefanos N. Children (Basel) Article Objective: 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. MDPI 2023-04-17 /pmc/articles/PMC10137206/ /pubmed/37189987 http://dx.doi.org/10.3390/children10040738 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article López-Gil, José Francisco García-Hermoso, Antonio Smith, Lee Gallego, Alejandra Victoria-Montesinos, Desirée Ezzatvar, Yasmin Hershey, Maria S. Gutiérrez-Espinoza, Héctor Mesas, Arthur Eumann Jiménez-López, Estela Sánchez-Miguel, Pedro Antonio López-Benavente, Alba Moreno-Galarraga, Laura Chen, Sitong Brazo-Sayavera, Javier Fernandez-Montero, Alejandro Alcaraz, Pedro Emilio Panisello Royo, Josefa María Tárraga-López, Pedro J. Kales, Stefanos N. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10137206/ https://www.ncbi.nlm.nih.gov/pubmed/37189987 http://dx.doi.org/10.3390/children10040738 |
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