López-Gil José Francisco, García-Hermoso Antonio, Smith Lee, Gallego Alejandra, Victoria-Montesinos Desirée, Ezzatvar Yasmin, Hershey Maria S, Gutiérrez-Espinoza Héctor, Mesas Arthur Eumann, Jiménez-López Estela, Sánchez-Miguel Pedro Antonio, López-Benavente Alba, Moreno-Galarraga Laura, Chen Sitong, Brazo-Sayavera Javier, Fernandez-Montero Alejandro, Alcaraz Pedro Emilio, Panisello Royo Josefa María, Tárraga-López Pedro J, Kales Stefanos N
Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, 31006 Pamplona, Spain.
Department of Environmental Health, Harvard University T.H. Chan School of Public Health, Boston, MA 02138, USA.
Children (Basel). 2023 Apr 17;10(4):738. doi: 10.3390/children10040738.
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 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. The 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. 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.
本文旨在描述一项试点整群随机对照试验（RCT）的方案，该试验将评估基于生活方式的干预措施的效果。该项目将有多个目标。本项目的主要目标是确定基于生活方式的干预措施对学龄儿童24小时运动行为和地中海饮食（MedDiet）依从性的6个月影响。本项目的次要目标是测试这种基于生活方式的干预措施对一系列相关健康相关结果（即人体测量、血压、感知体能、睡眠习惯和学业成绩）的干预效果。第三目标是调查这种干预措施对父母/监护人24小时运动行为和对MedDiet依从性的“光环”效应。该试验将是一项提交给临床试验注册中心的整群RCT。该方案将根据RCT的SPIRIT指南和整群RCT的CONSORT声明扩展版制定。共有153名符合条件的6至13岁学龄儿童的父母/监护人将被随机分为干预组或对照组。本项目侧重于两个基本支柱：24小时运动行为和MedDiet。它将主要关注父母/监护人与他们孩子之间的关系。学龄儿童饮食和24小时运动行为的行为改变策略将基于通过信息图表、视频食谱、简短视频片段和视频对父母/监护人进行健康生活方式教育。目前关于24小时运动行为和对MedDiet依从性的大多数知识基于横断面或纵向队列研究，因此有必要设计和开展RCT，以获得更有力的证据，证明健康生活方式计划对增加学龄儿童24小时运动行为和提高对MedDiet依从性的效果。
