Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), Instituto de Investigación Sanitaria de Navarra (IdiSNA), Avenida de Barañain S/N 31008, Pamplona, Navarra, Spain.
CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.
Trials. 2023 Aug 14;24(1):531. doi: 10.1186/s13063-023-07494-8.
Evidence suggests that movement patterns, including physical activity, sedentary behavior, and sleep duration, throughout a 24-h period, have a significant impact on biological processes and health outcomes for both young and adult populations. However, 80% of adolescents worldwide are not sufficiently active, and many children do not meet international physical activity recommendations for their age. Thus, the aim of this study is to evaluate the impact of a 12-week gamified family-based health and exercise intervention on physical fitness, basic motor competencies, mental and behavioral health, and adherence to 24-h movement guidelines in children aged 4 to 5 years old. The study will evaluate changes in sedentary levels, physical fitness, basic motor competencies, mental and behavioral disorders, adherence to the exercise program, and compliance with physical activity recommendations. In addition, the aim of this protocol is to describe the scientific rationale in detail and to provide information about the study procedures.
METHODS/DESIGN: A total of 80 children, aged 4 to 5 years old, will be randomly assigned in a 1:1 ratio to one of two groups: the exercise group and the routine care group. The exercise group will undergo a 12-week exercise intervention, followed by a 12-week follow-up period. On the other hand, the routine care group will undergo a 12-week period of routine care, followed by a 12-week follow-up control period. The exercise program will be implemented in a family setting and facilitated through a gamified web platform with online supervision, with the hypothesis that it will have a positive impact on physical fitness, anthropometric measures, basic motor competencies, and adherence to 24-h movement guidelines.
The results of this study will provide valuable insights into the impact of a gamified, family-oriented health and exercise program on various aspects of health, including physical fitness, basic motor competencies, mental and behavioral well-being, and adherence to 24-h movement guidelines. The findings will contribute to closing the gap in current knowledge on the effectiveness of these types of interventions for children and their parents. These findings will also contribute to the development of future guidelines for promoting physical activity in children who do not meet the World Health Organization's recommended levels. An online "3, 2, 1 Move on Study" is believed to increase accessibility, promoting health equity, and reducing economic barriers for all children and their families across diverse social groups.
Trial registration: NCT05741879 . Registered February 14, 2023, Version 1.
有证据表明，在 24 小时内的运动模式，包括体力活动、久坐行为和睡眠时间，对年轻和成年人群的生物过程和健康结果有重大影响。然而，全球 80%的青少年活动量不足，许多儿童不符合其年龄的国际体力活动建议。因此，本研究旨在评估为期 12 周的基于家庭的游戏化健康和锻炼干预对 4 至 5 岁儿童的身体健康、基本运动能力、心理健康和行为以及对 24 小时运动指南的依从性的影响。该研究将评估久坐水平、身体健康、基本运动能力、心理和行为障碍、对锻炼计划的依从性以及对体力活动建议的遵守情况。此外，本方案的目的是详细说明科学原理，并提供有关研究程序的信息。
方法/设计：总共将 80 名 4 至 5 岁的儿童随机分配到 1:1 的比例到两个组之一：运动组和常规护理组。运动组将接受 12 周的锻炼干预，然后是 12 周的随访期。另一方面，常规护理组将接受 12 周的常规护理，然后是 12 周的随访对照期。锻炼计划将在家庭环境中实施，并通过具有在线监督的游戏化网络平台进行，假设它将对身体健康、人体测量指标、基本运动能力和对 24 小时运动指南的依从性产生积极影响。
本研究的结果将为基于家庭的游戏化健康和锻炼计划对身体健康、基本运动能力、心理健康和行为以及对 24 小时运动指南的依从性等多个方面的影响提供有价值的见解。研究结果将有助于缩小目前对这些类型的干预措施对儿童及其父母有效性的认识差距。这些发现还将为制定未来的指南提供信息，以促进不符合世界卫生组织建议水平的儿童的身体活动。一个在线的“3, 2, 1 Move on Study”被认为可以提高可及性，促进健康公平，并为所有儿童及其家庭减少不同社会群体的经济障碍。
试验注册：NCT05741879。注册日期：2023 年 2 月 14 日，版本 1。
