BACKGROUND Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

中文翻译：

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通过使用新型智能手机技术平台 PEGASO 促进三个欧洲国家的青少年健康行为，适合未来：准实验性、受控、多中心试验的研究方案。

背景 针对青少年的身体活动、饮食、睡眠和久坐行为的行为改变干预措施在通过智能手机提供时显示出前景。然而，迄今为止，尚无证据表明基于智能手机的多组分干预措施的有效性。利用以用户为中心的设计方法，我们开发了一个基于理论的多维系统 PEGASO Fit For Future (PEGASO F4F)，它利用复杂的游戏机制，包括智能手机应用程序、智能手机游戏和活动传感器，以激励青少年采取在采用和保持健康生活方式方面发挥积极作用。本文描述了评估 PEGASO 系统的可行性、可用性和有效性（知识/意识和生活方式的行为改变）的研究协议。方法 我们正在西班牙、意大利和英国（英格兰、苏格兰）的 4 个地点进行为期 6 个月的准实验对照整群试验。我们计划以 2:1 的比例从中学招募 525 名 13-16 岁的青少年。干预组提供 PEGASO 系统，而对照组继续他们通常的教育程序。结果包括 PEGASO 系统的可行性、接受度和可用性，以及组间和组内动机、自我报告的饮食、身体活动、久坐和睡眠行为、人体测量学测量和有关健康生活方式的知识的变化。讨论 PEGASO F4F 将提供证据证明跨文化异同的可行性，基于多维智能手机的青少年行为改变干预的可接受性和可用性。该研究将探讨促使青少年在使用智能手机技术时适应和保持健康生活方式的促进因素、挑战和障碍。这种基于 ICT 的多组分干预的积极结果可能在临床层面、改善青少年健康和公共卫生层面具有重大意义，因为它可以提供一种有影响力的工具，可以对抗成年期慢性病的发展。试验注册 https://clinicaltrials.gov 注册号：NCT02930148，2016 年 10 月 4 日注册。这种基于 ICT 的多组分干预的积极结果可能在临床层面、改善青少年健康和公共卫生层面具有重大意义，因为它可以提供一种有影响力的工具，可以对抗成年期慢性病的发展。试验注册 https://clinicaltrials.gov 注册号：NCT02930148，2016 年 10 月 4 日注册。这种基于 ICT 的多组分干预的积极结果可能在临床层面、改善青少年健康和公共卫生层面具有重大意义，因为它可以提供一种有影响力的工具，可以对抗成年期慢性病的发展。试验注册 https://clinicaltrials.gov 注册号：NCT02930148，2016 年 10 月 4 日注册。