A Cluster Randomized Controlled Trial of the <i>Archena Infancia Saludable</i> Project on 24-h Movement Behaviors and Adherence to the Mediterranean Diet among Schoolchildren: A Pilot Study Protocol

• Main Authors: José Francisco López-Gil (Author), Antonio García-Hermoso (Author), Lee Smith (Author), Alejandra Gallego (Author), Desirée Victoria-Montesinos (Author), Yasmin Ezzatvar (Author), Maria S. Hershey (Author), Héctor Gutiérrez-Espinoza (Author), Arthur Eumann Mesas (Author), Estela Jiménez-López (Author), Pedro Antonio Sánchez-Miguel (Author), Alba López-Benavente (Author), Laura Moreno-Galarraga (Author), Sitong Chen (Author), Javier Brazo-Sayavera (Author), Alejandro Fernandez-Montero (Author), Pedro Emilio Alcaraz (Author), Josefa María Panisello Royo (Author), Pedro J. Tárraga-López (Author), Stefanos N. Kales (Author)
• Format: Book
• Published: MDPI AG, 2023-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

<b>Objective:</b> 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 <i>Archena Infancia Saludable</i> 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. <b>Methods:</b> The <i>Archena Infancia Saludable</i> 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. <b>Conclusions:</b> 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.

Item Description

10.3390/children10040738
2227-9067