Protocol for a randomized controlled trial of a mobile app and wearable-based intervention promoted through physical education to enhance physical and psychological health in adolescents during out-of-school hours

一项随机对照试验方案,旨在评估通过体育教育推广的基于移动应用程序和可穿戴设备的干预措施,在课外时间增强青少年身心健康的效果。

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Abstract

BACKGROUND: The use of new technologies to promote physical activity among adolescents has gained particular relevance in recent years. However, the methodological designs, as well as the instruments used, make it difficult to compare the studies conducted. METHODS: This protocol describes a single-blind, seven-arm randomized controlled trial designed to evaluate the effectiveness of mobile apps and wearable devices in promoting physical activity and improving physical and psychological health among adolescents aged 12 to 16. The intervention, conducted over two 12-week periods, is integrated into physical education (PE) settings to encourage device use during out-of-school hours. Participants will be randomly assigned to one of six experimental groups (EGs) or a control group (CG). During the intervention, EG adolescents must complete progressively increasing step goals (from 5,000 to 12,000 steps/session) at least three times per week. The primary outcomes include physical activity level, anthropometric and body composition, physical fitness, and psychological variables, while secondary outcomes include dietary habits, device usability, and participant satisfaction. Assessments will be conducted at three time points: baseline, post-test, and re-test. DISCUSSION: This protocol addresses previous research limitations by ensuring methodological rigor, standardized procedures, and objective assessments. This standardized protocol for the use of mobile apps and wearables promoted in the field of physical education is expected to enable high-quality scientific research studies that truly observe the potential of these tools to improve the physical health of adolescents, since one of the main problems observed when using these technologies was the lack of standardization and attention to key aspects, which led to premature abandonment of the program. TRIAL REGISTRATION: This study protocol has been reviewed and approved by the Catholic University of Murcia (code: CE022102). It is registered at ClinicalTrials.gov (ID: NCT06140225. Registration date: 11/14/2023). All participants will provide written informed consent before enrollment. The study will be conducted in accordance with the principles of the Declaration of Helsinki. Data may be made available upon reasonable request, in accordance with ethical and legal guidelines.

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