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
Keywords: 
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
Issue Date: 
2023
ISSN: 
2227-9067
Note: 
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license
Citation: 
López-Gil, J. F.; García-Hermoso, A.; Smith, L.; et al. "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), 2023, 738
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.

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