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
Descripción
Sumario: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.

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