Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial
Authors: Puigdomenech Elisa , Martin Anne , Lang Alexandra , Adorni Fulvio , Gomez Santiago Felipe , McKinstry Brian , Prinelli Federica , Condon Laura , Rashid Rajeeb , Caon Maurizio , Atkinson Sarah , Lafortuna Claudio L. , Ciociola Valentina , Hanley Janet , McCloughan Lucy , Castell Conxa , Espallargues Mireia ,   on behalf of the PEGASO Fit For Future Consortium, Carrion Carme , Espallargues Mireia , Gomez Santiago Felipe , Puigdomenech Elisa , Castell Conxa , Becker Till , Dunwell Ian , Bul Kim , Adorni Fulvio , Camarenti Martina , Ciociola Valentina , Crespi Chiara , Jesuthasan Nithiya , Lafortuna Claudio , Modoni Gianfranco , Prinelli Federica , Rizzo Giovanna , Sacco Marco , Sojic Aleksandra , Tabozzi Sarah , Jesuthasan Nithiya , Grossenbacher Olivier , Lemay Mathieu , Calvo Enric Muntané , Miralles Felip , Orte Silvia , Solà Marc , Velickovski Filip , Brivio Mauro , Guarneri Maria Renata , Angelini Leonardo , Caon Maurizio , Carrino Stefano , Mugellini Elena , Delaini Cesare , Morosini Dalia , Decandia Marco , Facchinetti Sara , Migliavacca Andrea , Mura Silvana , Bianchi Luca , Mazzola Marco , Repetti Sandro , Andreoni Giuseppe , Mazzola Alessandra , Perego Paolo , Standoli Carlo Emilio , Candea Ciprian , Candea Gabriela , Azzolini Massimiliano , Bianconi Luca , Costacurta Marco , Degano Cristiana , Podda Fabio , Ascolese Antonio , Pannese Lucia , McCloughan Lucy , Hanley Janet , Laird Yvonne , Martin Anne , McKinstry Brian , Rashid Rajeeb , Scott George , Serrano Jose , Atkinson Sarah , Cobb Sue , Condon Laura , Coulson Neil , Lang Alexandra , Langley Alyson 
Published: December 2019

Abstract
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.