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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.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.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.https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

Background:Promotion of physical activity, healthy eating, adequate sleep and reduced sedentary behavior in adolescents is a major priority globally given the current increase in population health challenges of non-communicable diseases and risk factors such as obesity. Adolescents are highly engaged with mobile technology, but the challenge is to engage them with mHealth technology. Recent innovations in mobile technology provide opportunities to promote a healthy lifestyle in adolescents. An increasingly utilized approach to facilitate increased engagement with mHealth technology is to involve potential users in the creation of the technology.Objective:To describe the process of and findings from co-designing and prototyping components of the PEGASO Fit for Future mHealth intervention for adolescents from different cultural backgrounds.Methods:Seventy-four adolescents aged 13-16 years from Spain, Italy and the United Kingdom participated in the co-design of the PEGASO Fit for Future technology. In three iterative cycles over 12 months, participants were involved in the co-design, refinement and feasibility testing of a system consisting of diverse mobile applications with a variety of functions and facilities to encourage healthy weight promoting behaviors. In the first iteration, participants attended a single workshop session and were presented with mock-ups or early-version prototypes of different apps for user requirements assessment and review. During the second iteration, prototypes of all apps were tested by participants for one week at home or school. In the third iteration, further developed prototypes were tested for two weeks. Participants’ use experience feedback and development ideas were collected from focus groups and completion of questionnaires.Results:For the PEGASO Fit for Future technology to be motivating and engaging, participants suggested that it should (i) allow personalization of the interface, (ii) have age-appropriate and easy to understand language (of icons, labels, instructions, notifications), (iii) provide easily accessible tutorials on how to use the app or navigate through a game, (iv) present a clear purpose and end goal, (v) have an appealing and self-explanatory reward systems, (vi) offer variation in gamified activities within apps and the serious game, and (vii) allow to seek peer-support and connect with peers for competitive activities within the technology.Conclusions:Incorporating adolescents’ preferences, the PEGASO Fit for Future technology combines the functions of a self-monitoring, entertainment, advisory, and social support tool. This was the first study demonstrating that it is possible to develop a complex smartphone-based technological system applying the principles of co-design to mHealth technology with adolescents across three countries. Findings of this study informed the development of an mHealth system for healthy weight promotion to be tested in a controlled multi-national pilot trial.

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.