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

Date

2023

Authors

Smith, Lee
Gallego, Alejandra
Victoria-Montesinos, Desirée
Ezzatvar, Yasmin
Hershey, María Soledad
Gutiérrez Espinoza, Héctor
Mesas, Arthur
Jiménez-López, Estela

Director

Publisher

MDPI
Acceso abierto / Sarbide irekia
Artículo / Artikulua
Versión publicada / Argitaratu den bertsioa

Project identifier

Impacto
OpenAlexGoogle Scholar
No disponible en Scopus

Abstract

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.

Description

Keywords

Children, Family, Lifestyle, Movement guidelines, Movement recommendations, Parents, Physical activity, Screen time, Sedentary behavior, Sleep duration

Department

Ciencias de la Salud / Osasun Zientziak

Faculty/School

Degree

Doctorate program

item.page.cita

López-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.

item.page.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.

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