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

Elisa Puigdomenech, Anne Martin, Alexandra Lang, Fulvio Adorni, Santiago Felipe Gomez, Brian McKinstry, Federica Prinelli, Laura Condon, Rajeeb Rashid, Maurizio Caon, Sarah Atkinson, Claudio L Lafortuna, Valentina Ciociola, Janet Hanley, Lucy McCloughan, Conxa Castell, Mireia Espallargues, PEGASO Fit For Future Consortium, Carme Carrion, Mireia Espallargues, Santiago Felipe Gomez, Elisa Puigdomenech, Conxa Castell, Till Becker, Ian Dunwell, Kim Bul, Fulvio Adorni, Martina Camarenti, Valentina Ciociola, Chiara Crespi, Nithiya Jesuthasan, Claudio Lafortuna, Gianfranco Modoni, Federica Prinelli, Giovanna Rizzo, Marco Sacco, Aleksandra Sojic, Sarah Tabozzi, Nithiya Jesuthasan, Olivier Grossenbacher, Mathieu Lemay, Enric Muntané Calvo, Felip Miralles, Silvia Orte, Marc Solà, Filip Velickovski, Mauro Brivio, Maria Renata Guarneri, Leonardo Angelini, Maurizio Caon, Stefano Carrino, Elena Mugellini, Cesare Delaini, Dalia Morosini, Marco Decandia, Sara Facchinetti, Andrea Migliavacca, Silvana Mura, Luca Bianchi, Marco Mazzola, Sandro Repetti, Giuseppe Andreoni, Alessandra Mazzola, Paolo Perego, Carlo Emilio Standoli, Ciprian Candea, Gabriela Candea, Massimiliano Azzolini, Luca Bianconi, Marco Costacurta, Cristiana Degano, Fabio Podda, Antonio Ascolese, Lucia Pannese, Lucy McCloughan, Janet Hanley, Yvonne Laird, Anne Martin, Brian McKinstry, Rajeeb Rashid, George Scott, Jose Serrano, Sarah Atkinson, Sue Cobb, Laura Condon, Neil Coulson, Alexandra Lang, Alyson Langley, Elisa Puigdomenech, Anne Martin, Alexandra Lang, Fulvio Adorni, Santiago Felipe Gomez, Brian McKinstry, Federica Prinelli, Laura Condon, Rajeeb Rashid, Maurizio Caon, Sarah Atkinson, Claudio L Lafortuna, Valentina Ciociola, Janet Hanley, Lucy McCloughan, Conxa Castell, Mireia Espallargues, PEGASO Fit For Future Consortium, Carme Carrion, Mireia Espallargues, Santiago Felipe Gomez, Elisa Puigdomenech, Conxa Castell, Till Becker, Ian Dunwell, Kim Bul, Fulvio Adorni, Martina Camarenti, Valentina Ciociola, Chiara Crespi, Nithiya Jesuthasan, Claudio Lafortuna, Gianfranco Modoni, Federica Prinelli, Giovanna Rizzo, Marco Sacco, Aleksandra Sojic, Sarah Tabozzi, Nithiya Jesuthasan, Olivier Grossenbacher, Mathieu Lemay, Enric Muntané Calvo, Felip Miralles, Silvia Orte, Marc Solà, Filip Velickovski, Mauro Brivio, Maria Renata Guarneri, Leonardo Angelini, Maurizio Caon, Stefano Carrino, Elena Mugellini, Cesare Delaini, Dalia Morosini, Marco Decandia, Sara Facchinetti, Andrea Migliavacca, Silvana Mura, Luca Bianchi, Marco Mazzola, Sandro Repetti, Giuseppe Andreoni, Alessandra Mazzola, Paolo Perego, Carlo Emilio Standoli, Ciprian Candea, Gabriela Candea, Massimiliano Azzolini, Luca Bianconi, Marco Costacurta, Cristiana Degano, Fabio Podda, Antonio Ascolese, Lucia Pannese, Lucy McCloughan, Janet Hanley, Yvonne Laird, Anne Martin, Brian McKinstry, Rajeeb Rashid, George Scott, Jose Serrano, Sarah Atkinson, Sue Cobb, Laura Condon, Neil Coulson, Alexandra Lang, Alyson Langley

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://ichgcp.net/clinical-trials-registry/NCT02930148" title="See in ClinicalTrials.gov">NCT02930148, registered 4 October 2016.

Keywords: Adolescents; Behaviour change; Diet; Health promotion; Mobile health; Obesity prevention; Physical activity; Sedentary behaviour; Serious game; Sleep; Smartphone application; eHealth; mHealth.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
This figure shows PEGASO smart garment and a wrist-worn activity tracker
Fig. 2
Fig. 2
This figure shows some screen shots of the Companion application
Fig. 3
Fig. 3
This figure shows some screen shot of the EDiary application

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