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Personalised Guidance Service for Lifestyle Management and Obesity Prevention in Teen-agers Pilot Study

NCT02930148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2016-10-12

No results posted yet for this study

Summary

the aims of the present study is to test the PEGASO system in real life conditions in Lombardy (Italy), England and Scotland (UK) and Catalonia (Spain), as well as to assess changes in teen-agers' awareness and lifestyles after the use of PEGASO system. Specifically, the investigators aim to:

1. To test the usability of PEGASO platform
2. To pilot approaches to testing the effectiveness of the system to:

1. Evaluate the increase of knowledge/awareness about healthy habits
2. Assess behavioural change in lifestyle, and specifically on target behaviours In particular, the pilot study will help to assess likely recruitment and retention in a controlled trial, to test the acceptability and utility of assessment procedures, to obtain estimates of effect size and variability to power a future substantive study

Conditions

  • Lifestyles

Interventions

OTHER

PEGASO System (ICT based system/mHealth solution)

Participants will be provided with a smart phone with the PEGASO system and will be asked to join the PEGASO community through the PEGASO Portal. Two smart garments, and two sensors will be provided at month 2 (to minimise the burden on the schools and participants allocating time and resources). The PEGASO System allows empowering the participants toward healthy habits, recording what he or she eats, monitor physical activity variables. The serious game is a central motivational component of PEGASO: it has an "energy bar", used up by the player's actions, and replenished when achieving their behavioural goals, and it implements "research" mechanics that require the player to apply and develop their nutritional knowledge. The Bridge allows the connection between the PEGASO ecosystem and the personal health folder by creating a report to be shared with physicians

Sponsors & Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

    collaborator OTHER_GOV

  • Politecnico di Milano

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • Agència de Qualitat i Avaluació Sanitàries

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-04-30
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930148 on ClinicalTrials.gov