Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02930148 |
| Other study ID # |
750-PEGASO |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
October 4, 2016 |
| Last updated |
October 11, 2016 |
| Start date |
October 2016 |
| Est. completion date |
May 2017 |
Study information
| Verified date |
September 2016 |
| Source |
Agència de Qualitat i Avaluació Sanitàries |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Spain: Departament de Salut de la Generalitat de CatalunyaUnited States: Federal Government |
| Study type |
Interventional
|
Clinical Trial 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
Description:
A multi-centre quasi experimental controlled pilot study will be undertaken to evaluate a 6
months ICT based intervention, the PEGASO System, to promote healthy habits among
adolescents. The study will include adolescents from four sites: England (UK), Scotland
(UK), Lombardy (Italy) and Catalonia (Spain). Participants in he intervention group will
test the PEGASO ecosystem from October 2016 to March 2017 while those in the comparative
group will not have access to the PEGASO ecosystem. The sample selection will be carried out
in two stages: in the first phase, schools with medium-low socioeconomic level will be
selected by convenience sampling; in the second phase classes will be selected for
participation in each school in agreement with schools principals/ head teachers. A total of
525 adolescents from participating high schools will be asked to participate in the study as
intervention or comparative group, in a 2:1 ratio. Consequently, approximately, 350
participants of the four pilot sites will be testing the PEGASO platform, whilst 175 will be
the comparative group. Decisions about appropriate sample sizes were underpinned by a range
of considerations, including the study's aims, operational constraints, the accuracy of the
survey estimates and costs.
The PEGASO system is based on the comprehensive Behavior Change Wheel (BCW) framework and in
particular by the Capability-Opportunity-Motivation-Behavior (COM-B) system. This provided
the theoretical grounding for the content and implementation approach of the behavior change
interventions embedded within the components of the PEGASO system. The innovative key
component of the PEGASO system is the behavior recognition system which allows detection and
evaluation of participants' real-time behavior (collected through other components of the
PEGASO system). While the target behaviors allow focusing the intervention on a specific
task for each participant, the link between behavior change theory (Behavior Change wheel)
and the target behaviors is ensured via the COM-B questionnaire. Participants will have the
opportunity to choose one target behavior at the time. When selecting a novel target
behavior, participants will be asked to complete the COM-B questionnaire. The answers for
each question subset will guide which component of the COM-B behavior system adopt to target
the content of the behavior change intervention. For instance, the messaging framework in
the PEGASO Companion App will select messages that are associated with participants'
preferences expressed in the COM-B questionnaire. This will provide an intervention that is
personalized to the different needs of the individual intervention participant.
To analyze the effectiveness of the platform in modifying knowledge/awareness and behaviors
the investigators will compare intervention and control groups by utilizing an
intention-to-treat (ITT) approach, thus inferring the effect independently from drop-outs
and non-adherence.
The participants will be provided with a smart phone (android, version 5.0) for the duration
of the study. Two smart garments, a smart garment sensor and an activity bracelet will be
provided at month 3. The smart phones will have all apps of the PEGASO ecosystem installed.
In addition, participants will be asked to join the PEGASO community by signing in to the
PEGASO Portal (http://portal.PEGASOf4f.eu/web/others/sign-in).
PEGASO comprises seven different apps. The objective of the PEGASO Companion app is to
encompass the other six apps and provide a seamless and unique experience to the
participant. Companion App. The aim of the Companion App is to make active life more
attractive, helps participants to eat more healthily and connects participants with their
peers. Developed as native Android application (client + server), the Companion is a
Personal Digital "Friend" acting as a daily-life guide for coaching, caring for, and
empowering the participants in their activities toward healthy habits. The Companion App
will allow the user to have dynamic stream of information (about their achievements and the
achievements of the other users that chose to connect with the user within the PEGASO
system) and to access all other applications. Data acquired via sensors (embedded in the
Smartphone or garments) will be presented to the user via a specific interface developed
inside the Health Companion App. The Companion App also includes a rewarding system and the
gamification module will allow the system to: achieve One time rewards, achieve Cyclic
events and achieve Rewards (e.g., fit coins, badges, experience points) for the selected
target behavior (diet or physical activity). Challenges app. The Companion app includes a
"challenge" component which participants can use for creating and accepting different type
of challenges. This application allows users to challenge themselves and other users in a
competitive or collaborative way. eDiary app. The eDiary is an application that allows the
participant to enter some information about their diet and provides feedback about the
healthy eating habit. This app will also provide suggestions (e.g., food groups and recipes)
to the user to improve the dietary habits. The eDiary app is gamified in order to improve
the participants' experience and to introduce an element of fun that can sustain engagement
with the app and eating habits. PEGASO City app. The PEGASO City is a bridge between the
digital world of the PEGASO system with the physical world. The app has a twofold role
inside the PEGASO Health Companion: firstly, PEGASO City helps teenagers to find places that
are part of the PEGASO Stakeholder Ecosystem, and that provide them opportunities to act
healthy and progress towards the reach of their target behavior. Secondly, through the
empowerment provided by the integration of some of the HealthSquare functionalities, the
application provides the teenagers a set of possible interactions and actions that
contribute to the gamification process and the rewarding system. Dashboard app. The
Dashboard is an application that allows to see all the data acquired by the PEGASO system.
The app shows all the activities data such as steps and minutes of activities, sleep time,
type of activities made during the course of the day; in addition, it reports if the user
reaches the target behavior and awards him/her with badges and trophies. Thanks to the
Dashboard the participants are able to check their behavior and perform reflection and
self-monitoring by extracting suggestions from the apps. Users can also control the battery
and memory status of each PEGASO device. Smart Garments and bracelets sensors. Smart
garments consist of a t-shirt/crop top with embedded textile electrodes. The t-shirt/crop
top comes with a data logger (monitoring/recording system) which snaps on the front side of
the t-shirt by using standard snap buttons. The smart garments measure heart rate (ECG) and
physical activities (accelerometer) whereas the bracelet monitors physical activities and
sleep. Data collected through garments and bracelets are transferred to a smart phone and
linked to the Health Companion app as well as the serious game. Participants will be
provided with a User Manual in local languages. Serious game. The game serves a central role
as the motivational component of PEGASO. As such, it needs to entertain and engage the
player, whilst utilizing the PEGASO ecosystem to capture information about lifestyles and
encourage positive health behavior changes. There are two central behavioral mechanisms
within the game: a) an "energy bar", used up by the player's actions in the game, and
replenished by them achieving their behavioral goals such as increased physical activity or
improved diet, and b) the game implements "research" mechanics that require the player to
apply and develop their nutritional knowledge of various food sources. The current game
format is an infinite game which, through the energy mechanic, promotes regular use and
goal-achievement within the PEGASO ecosystem, as well as being conducive to short, frequent
play rather than long single sessions. PEGASO Web Portal. The PEGASO Web Portal allows
participants to socially interact and learn via training module; two (technological):
aggregate data and services across the whole PEGASO platform (images, video, blog materials,
activities data, no. of steps, no. of km). Potentially users of the PEGASO Portal are
teenagers, parents and experts. The Web portal is accessible from both mobile devices and
computers. Report App. The connection between the PEGASO ecosystem and the personal health
folder is established through the BRIDGE system and will be deployed and tested in two pilot
sites only: namely Lombardy region and Catalonia. The BRIDGE allows extracting health data
collected and elaborated into the PEGASO ecosystem and to create a report to be shared with
physicians into the personal health folder (PHF).
Chi-squared test will be used to analyze the association between independent qualitative
variables, along with the McNemar test for paired samples. The Student t-test will be used
for the comparison of means between two groups, and the paired t-test will be applied to
assess changes within one same group. Alternatively, the corresponding nonparametric tests
will be used, as required. The relationship between quantitative variables will be analyzed
using Pearson's correlation coefficient or Spearman coefficient in the case of
asymmetrically distributed variables. Multivariate linear regression analysis and logistic
regression analysis will be used to analyze the variables determining the changes in
physical activity and eating and sleeping habits. In order to analyze the effect of the
intervention, comparison will be made of the changes observed in the comparison group (CG)
versus the intervention group (IG), with estimation of the Cohen d statistic, adjusting for
the variables that may influence the results. A multilevel analysis will be performed to
determine the effect of the different pilot sites or schools. The effect of the intervention
could be modified by gender, cultural and socioeconomic level, body mass index (BMI), as
well as by the baseline lifestyles, which will be controlled in the analysis. Separate
analyses will also be performed for females, males, low and high socio-economic level to
assess the effect of the intervention in these categories of interest. The level of
statistical significance will be set at α=0.05 and all tests will be two-tailed. Statistical
analyses will be carried out using the software packages SPSS, version 22.0 (SPSS Inc,
Chicago, IL) and Stata (StataCorp. 2009. Stata Statistical Software: Release 11. College
Station, TX: StataCorp LP). Conversational methods will be used to collect data in focus
groups. All of them will be audio and/or videotaped and transcribed systematically,
literally, and anonymously. An analysis will be made of thematic content, coding the data
and grouping them into predefined categories based on topics. The analysis will be done with
the support of Atlas.Ti and by triangulation of analyst.
Ethical approval has been asked to clinical research ethics committee (CEIC) of all four
pilot sites: ACCORD Medical Research Ethics Committee (AMREC) in Scotland and England, IRCCS
Policlinico of Milan in Lombardy and CEIC of IDIAP Jordi Gol in Catalonia. Subjects will be
informed of the objectives of the project. The confidentiality of the recruited subjects and
their data will be ensured in accordance with the provision of European current legislation
on personal data protection: 95/46/EC EU Directive (DPD) on Data Protection and the EU
2016/679 General Data Protection Regulation.
