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...

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Autores: López-Gil, J.F. (José Francisco)|||/items/642fa46c-6169-49e7-87c8-a934e9c27563, García-Hermoso, A. (Antonio)|||/items/1a7e0394-33e5-4028-94e8-bfe1a83007fb, Smith, L. (Lee)|||/items/1b5dadb8-1be3-4c5a-bd24-94355eb6d151, Gallego, A. (Alejandra)|||/items/9c33a478-97be-42ae-9ef0-67ed524cca13, Victoria-Montesinos, D. (Desirée)|||/items/634b87d9-8f96-497e-8b1c-2d1429899be1, Ezzatvar, Y. (Yasmin)|||/items/9e3f827e-2457-4471-afae-83b178d855fc, Hershey-de-la-Cruz, M.S. (María Soledad)|||/items/32d1f371-99a2-4b2a-a1da-737278a5fb18, Gutiérrez-Espinoza, H. (Héctor)|||/items/779e512b-7eab-4a26-a5c2-9357f8ac6843, Eumann-Mesas, A. (Arthur)|||/items/5ddf8937-80a1-4b4b-8c33-dfb7b821844f, Jiménez-López, E. (Estela)|||/items/5b540177-7732-4f68-bfd2-bbd6cb976f2a, Sánchez-Miguel, P.A. (Pedro Antonio)|||/items/5eb75482-a623-499b-b6db-7e5dc88e6075, López-Benavente, A. (Alba)|||/items/2ab9df79-24a0-42c3-9920-bdeb170214da, Moreno-Galarraga, L. (Laura)|||/items/3583c276-7f01-47e6-8c87-e583043a1c1f, Chen, S. (Sitong)|||/items/9d48186d-428c-4a3c-80be-323818ab893e, Brazo-Sayavera, J. (Javier)|||/items/73ea7351-754c-44e3-a97c-a0fd4a2aacf9, Fernandez-Montero, A. (Alejandro)|||/items/0d23602b-1c19-44e7-b698-bf919bed4ea7, Alcaraz, P.E. (Pedro Emilio)|||/items/71c3e139-d4bf-4dca-818d-e8dcc5e0a172, Panisello-Royo, J.M. (Josefa María)|||/items/d371186f-8bf8-4590-b47e-ec55aa422aaf, Tarraga-López, P.J. (Pedro J.)|||/items/f8e77238-0028-4dc5-9b16-75c16b898148, Kales, S.N. (Stefanos N.)|||/items/e8c58bd7-cb4a-4009-a2b5-4b981584d5f9
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/66521
Acceso en línea:https://hdl.handle.net/10171/66521
Access Level:acceso abierto
Palabra clave:Área de Medicina Clínica y Epidemiología
Physical activity
Screen time
Sedentary behavior
Sleep duration
Movement guidelines
Movement recommendations
Children
Lifestyle
Parents
Family,SLEEP SCREENING TOOL
SCHOOL-AGED CHILDREN
QUALITY-OF-LIFE
PHYSICAL-ACTIVITY
SEDENTARY BEHAVIOR
GUIDELINES
RECOMMENDATIONS
ADOLESCENTS
QUESTIONNAIRE
PERFORMANCE
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oai_identifier_str oai:dadun.unav.edu:10171/66521
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repository_id_str
dc.title.none.fl_str_mv 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
spellingShingle 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, J.F. (José Francisco)|||/items/642fa46c-6169-49e7-87c8-a934e9c27563
Área de Medicina Clínica y Epidemiología
Physical activity
Screen time
Sedentary behavior
Sleep duration
Movement guidelines
Movement recommendations
Children
Lifestyle
Parents
Family,SLEEP SCREENING TOOL
SCHOOL-AGED CHILDREN
QUALITY-OF-LIFE
PHYSICAL-ACTIVITY
SEDENTARY BEHAVIOR
GUIDELINES
RECOMMENDATIONS
ADOLESCENTS
QUESTIONNAIRE
PERFORMANCE
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_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_sort 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
dc.creator.none.fl_str_mv López-Gil, J.F. (José Francisco)|||/items/642fa46c-6169-49e7-87c8-a934e9c27563
García-Hermoso, A. (Antonio)|||/items/1a7e0394-33e5-4028-94e8-bfe1a83007fb
Smith, L. (Lee)|||/items/1b5dadb8-1be3-4c5a-bd24-94355eb6d151
Gallego, A. (Alejandra)|||/items/9c33a478-97be-42ae-9ef0-67ed524cca13
Victoria-Montesinos, D. (Desirée)|||/items/634b87d9-8f96-497e-8b1c-2d1429899be1
Ezzatvar, Y. (Yasmin)|||/items/9e3f827e-2457-4471-afae-83b178d855fc
Hershey-de-la-Cruz, M.S. (María Soledad)|||/items/32d1f371-99a2-4b2a-a1da-737278a5fb18
Gutiérrez-Espinoza, H. (Héctor)|||/items/779e512b-7eab-4a26-a5c2-9357f8ac6843
Eumann-Mesas, A. (Arthur)|||/items/5ddf8937-80a1-4b4b-8c33-dfb7b821844f
Jiménez-López, E. (Estela)|||/items/5b540177-7732-4f68-bfd2-bbd6cb976f2a
Sánchez-Miguel, P.A. (Pedro Antonio)|||/items/5eb75482-a623-499b-b6db-7e5dc88e6075
López-Benavente, A. (Alba)|||/items/2ab9df79-24a0-42c3-9920-bdeb170214da
Moreno-Galarraga, L. (Laura)|||/items/3583c276-7f01-47e6-8c87-e583043a1c1f
Chen, S. (Sitong)|||/items/9d48186d-428c-4a3c-80be-323818ab893e
Brazo-Sayavera, J. (Javier)|||/items/73ea7351-754c-44e3-a97c-a0fd4a2aacf9
Fernandez-Montero, A. (Alejandro)|||/items/0d23602b-1c19-44e7-b698-bf919bed4ea7
Alcaraz, P.E. (Pedro Emilio)|||/items/71c3e139-d4bf-4dca-818d-e8dcc5e0a172
Panisello-Royo, J.M. (Josefa María)|||/items/d371186f-8bf8-4590-b47e-ec55aa422aaf
Tarraga-López, P.J. (Pedro J.)|||/items/f8e77238-0028-4dc5-9b16-75c16b898148
Kales, S.N. (Stefanos N.)|||/items/e8c58bd7-cb4a-4009-a2b5-4b981584d5f9
author López-Gil, J.F. (José Francisco)|||/items/642fa46c-6169-49e7-87c8-a934e9c27563
author_facet López-Gil, J.F. (José Francisco)|||/items/642fa46c-6169-49e7-87c8-a934e9c27563
García-Hermoso, A. (Antonio)|||/items/1a7e0394-33e5-4028-94e8-bfe1a83007fb
Smith, L. (Lee)|||/items/1b5dadb8-1be3-4c5a-bd24-94355eb6d151
Gallego, A. (Alejandra)|||/items/9c33a478-97be-42ae-9ef0-67ed524cca13
Victoria-Montesinos, D. (Desirée)|||/items/634b87d9-8f96-497e-8b1c-2d1429899be1
Ezzatvar, Y. (Yasmin)|||/items/9e3f827e-2457-4471-afae-83b178d855fc
Hershey-de-la-Cruz, M.S. (María Soledad)|||/items/32d1f371-99a2-4b2a-a1da-737278a5fb18
Gutiérrez-Espinoza, H. (Héctor)|||/items/779e512b-7eab-4a26-a5c2-9357f8ac6843
Eumann-Mesas, A. (Arthur)|||/items/5ddf8937-80a1-4b4b-8c33-dfb7b821844f
Jiménez-López, E. (Estela)|||/items/5b540177-7732-4f68-bfd2-bbd6cb976f2a
Sánchez-Miguel, P.A. (Pedro Antonio)|||/items/5eb75482-a623-499b-b6db-7e5dc88e6075
López-Benavente, A. (Alba)|||/items/2ab9df79-24a0-42c3-9920-bdeb170214da
Moreno-Galarraga, L. (Laura)|||/items/3583c276-7f01-47e6-8c87-e583043a1c1f
Chen, S. (Sitong)|||/items/9d48186d-428c-4a3c-80be-323818ab893e
Brazo-Sayavera, J. (Javier)|||/items/73ea7351-754c-44e3-a97c-a0fd4a2aacf9
Fernandez-Montero, A. (Alejandro)|||/items/0d23602b-1c19-44e7-b698-bf919bed4ea7
Alcaraz, P.E. (Pedro Emilio)|||/items/71c3e139-d4bf-4dca-818d-e8dcc5e0a172
Panisello-Royo, J.M. (Josefa María)|||/items/d371186f-8bf8-4590-b47e-ec55aa422aaf
Tarraga-López, P.J. (Pedro J.)|||/items/f8e77238-0028-4dc5-9b16-75c16b898148
Kales, S.N. (Stefanos N.)|||/items/e8c58bd7-cb4a-4009-a2b5-4b981584d5f9
author_role author
author2 García-Hermoso, A. (Antonio)|||/items/1a7e0394-33e5-4028-94e8-bfe1a83007fb
Smith, L. (Lee)|||/items/1b5dadb8-1be3-4c5a-bd24-94355eb6d151
Gallego, A. (Alejandra)|||/items/9c33a478-97be-42ae-9ef0-67ed524cca13
Victoria-Montesinos, D. (Desirée)|||/items/634b87d9-8f96-497e-8b1c-2d1429899be1
Ezzatvar, Y. (Yasmin)|||/items/9e3f827e-2457-4471-afae-83b178d855fc
Hershey-de-la-Cruz, M.S. (María Soledad)|||/items/32d1f371-99a2-4b2a-a1da-737278a5fb18
Gutiérrez-Espinoza, H. (Héctor)|||/items/779e512b-7eab-4a26-a5c2-9357f8ac6843
Eumann-Mesas, A. (Arthur)|||/items/5ddf8937-80a1-4b4b-8c33-dfb7b821844f
Jiménez-López, E. (Estela)|||/items/5b540177-7732-4f68-bfd2-bbd6cb976f2a
Sánchez-Miguel, P.A. (Pedro Antonio)|||/items/5eb75482-a623-499b-b6db-7e5dc88e6075
López-Benavente, A. (Alba)|||/items/2ab9df79-24a0-42c3-9920-bdeb170214da
Moreno-Galarraga, L. (Laura)|||/items/3583c276-7f01-47e6-8c87-e583043a1c1f
Chen, S. (Sitong)|||/items/9d48186d-428c-4a3c-80be-323818ab893e
Brazo-Sayavera, J. (Javier)|||/items/73ea7351-754c-44e3-a97c-a0fd4a2aacf9
Fernandez-Montero, A. (Alejandro)|||/items/0d23602b-1c19-44e7-b698-bf919bed4ea7
Alcaraz, P.E. (Pedro Emilio)|||/items/71c3e139-d4bf-4dca-818d-e8dcc5e0a172
Panisello-Royo, J.M. (Josefa María)|||/items/d371186f-8bf8-4590-b47e-ec55aa422aaf
Tarraga-López, P.J. (Pedro J.)|||/items/f8e77238-0028-4dc5-9b16-75c16b898148
Kales, S.N. (Stefanos N.)|||/items/e8c58bd7-cb4a-4009-a2b5-4b981584d5f9
author2_role author
author
author
author
author
author
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author
author
author
author
author
author
author
author
author
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author
author
dc.contributor.none.fl_str_mv Dadun. Depósito Académico Digital Universidad de Navarra
dc.subject.none.fl_str_mv Área de Medicina Clínica y Epidemiología
Physical activity
Screen time
Sedentary behavior
Sleep duration
Movement guidelines
Movement recommendations
Children
Lifestyle
Parents
Family,SLEEP SCREENING TOOL
SCHOOL-AGED CHILDREN
QUALITY-OF-LIFE
PHYSICAL-ACTIVITY
SEDENTARY BEHAVIOR
GUIDELINES
RECOMMENDATIONS
ADOLESCENTS
QUESTIONNAIRE
PERFORMANCE
topic Área de Medicina Clínica y Epidemiología
Physical activity
Screen time
Sedentary behavior
Sleep duration
Movement guidelines
Movement recommendations
Children
Lifestyle
Parents
Family,SLEEP SCREENING TOOL
SCHOOL-AGED CHILDREN
QUALITY-OF-LIFE
PHYSICAL-ACTIVITY
SEDENTARY BEHAVIOR
GUIDELINES
RECOMMENDATIONS
ADOLESCENTS
QUESTIONNAIRE
PERFORMANCE
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.
publishDate 2023
dc.date.none.fl_str_mv 2023
2023-05-31
2023
2023-01-01
2023
2023-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10171/66521
url https://hdl.handle.net/10171/66521
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra
instname:Universidad de Navarra
instname_str Universidad de Navarra
reponame_str Dadun. Depósito Académico Digital de la Universidad de Navarra
collection Dadun. Depósito Académico Digital de la Universidad de Navarra
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling 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 ProtocolLópez-Gil, J.F. (José Francisco)|||/items/642fa46c-6169-49e7-87c8-a934e9c27563García-Hermoso, A. (Antonio)|||/items/1a7e0394-33e5-4028-94e8-bfe1a83007fbSmith, L. (Lee)|||/items/1b5dadb8-1be3-4c5a-bd24-94355eb6d151Gallego, A. (Alejandra)|||/items/9c33a478-97be-42ae-9ef0-67ed524cca13Victoria-Montesinos, D. (Desirée)|||/items/634b87d9-8f96-497e-8b1c-2d1429899be1Ezzatvar, Y. (Yasmin)|||/items/9e3f827e-2457-4471-afae-83b178d855fcHershey-de-la-Cruz, M.S. (María Soledad)|||/items/32d1f371-99a2-4b2a-a1da-737278a5fb18Gutiérrez-Espinoza, H. (Héctor)|||/items/779e512b-7eab-4a26-a5c2-9357f8ac6843Eumann-Mesas, A. (Arthur)|||/items/5ddf8937-80a1-4b4b-8c33-dfb7b821844fJiménez-López, E. (Estela)|||/items/5b540177-7732-4f68-bfd2-bbd6cb976f2aSánchez-Miguel, P.A. (Pedro Antonio)|||/items/5eb75482-a623-499b-b6db-7e5dc88e6075López-Benavente, A. (Alba)|||/items/2ab9df79-24a0-42c3-9920-bdeb170214daMoreno-Galarraga, L. (Laura)|||/items/3583c276-7f01-47e6-8c87-e583043a1c1fChen, S. (Sitong)|||/items/9d48186d-428c-4a3c-80be-323818ab893eBrazo-Sayavera, J. (Javier)|||/items/73ea7351-754c-44e3-a97c-a0fd4a2aacf9Fernandez-Montero, A. (Alejandro)|||/items/0d23602b-1c19-44e7-b698-bf919bed4ea7Alcaraz, P.E. (Pedro Emilio)|||/items/71c3e139-d4bf-4dca-818d-e8dcc5e0a172Panisello-Royo, J.M. (Josefa María)|||/items/d371186f-8bf8-4590-b47e-ec55aa422aafTarraga-López, P.J. (Pedro J.)|||/items/f8e77238-0028-4dc5-9b16-75c16b898148Kales, S.N. (Stefanos N.)|||/items/e8c58bd7-cb4a-4009-a2b5-4b981584d5f9Área de Medicina Clínica y EpidemiologíaPhysical activityScreen timeSedentary behaviorSleep durationMovement guidelinesMovement recommendationsChildrenLifestyleParentsFamily,SLEEP SCREENING TOOLSCHOOL-AGED CHILDRENQUALITY-OF-LIFEPHYSICAL-ACTIVITYSEDENTARY BEHAVIORGUIDELINESRECOMMENDATIONSADOLESCENTSQUESTIONNAIREPERFORMANCEObjective: 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.Dadun. Depósito Académico Digital Universidad de Navarra20232023-05-3120232023-01-0120232023-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/66521reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/665212026-06-21T12:47:57Z
score 15.300719