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

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ClinicalTrials.gov Identifier: NCT02930148
Recruitment Status : Unknown
Verified September 2016 by Agència de Qualitat i Avaluació Sanitàries.
Recruitment status was:  Not yet recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Collaborators:
Consiglio Nationale delle Richerche (CNR)
Politecnico di Milano
University of Nottingham
University of Edinburgh
Information provided by (Responsible Party):
Agència de Qualitat i Avaluació Sanitàries

Brief 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

Condition or disease Intervention/treatment Phase
Lifestyles Other: PEGASO System (ICT based system/mHealth solution) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Personalised Guidance Service for Lifestyle Management and Obesity Prevention in Teen-agers: A Multicenter Quasi-experimental Pilot Study
Study Start Date : October 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Intervention
Participants will be provided with a smart phone (android, version 5.0), two smart garments, a smart garment sensor and an activity bracelet will be provided at month 2 (to minimise the burden on the schools and participants allocating time and resources). The smart phones will have all apps of the PEGASO ecosystem installed.
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

No Intervention: Comparative
Participants will be asked to continue their routine daily physical and educational activities related to leading a healthy lifestyle.



Primary Outcome Measures :
  1. Change in dietary habits [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    Mediterranean Diet Quality Index for children and teenagers (KIDMED) questions

  2. Change in physical activity [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    The Physical Activity Questionnaire for Adolescents (PAQ-A)

  3. Change in sedentary behaviour [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    The Screen time-based sedentary behaviour questionnaire (SSBQ) from the HELENA study

  4. Change in sleeping habits [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    Sleep Habits Survey for Adolescents (SHSA)

  5. Change in lifestyles knowledge questionnaire [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    Ad hoc questionnaire on lifestyle knowledge

  6. Change in user experience of the PEGASO system [ Time Frame: 4 and 6 months after baseline ]
    Ad-hoc interviews pro-forma to assess user experience

  7. Change in the usability of the system [ Time Frame: 2, 4 and 6 months after baseline ]
    System Usability Scale (SUS questionnaire)

  8. Change in the emotions when using the system [ Time Frame: 4 and 6 months after baseline ]
    Emotional Metric Outcomes questionnaire

  9. Change in satisfaction when using the system [ Time Frame: 4 and 6 months after baseline ]
    Ad-hoc questionnaire for satisfaction

  10. Change in dietary habits [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    Ad-hoc questionnaire

  11. Change in physical activity [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    Ad-hoc questionnaire


Secondary Outcome Measures :
  1. Self-perceived health status [ Time Frame: Baseline and after intervention (6 months from baseline) ]
    One question from the SF-12

  2. Motivation [ Time Frame: Baseline and month 2, 4 and 6 after baseline ]
    Perceived Competence Scale

  3. Habit [ Time Frame: Continous data collection from month 1 to month 6 with data extraction at month 6 for analysis ]
    Self-Report Behavioural Automaticity Index (SBRAI)

  4. Self-awareness [ Time Frame: Continous data collection from month 1 to month 6 with data extraction at month 6 for analysis ]
    COM-B-Q Self-Assessment Questionnaire

  5. Weight [ Time Frame: Baseline and after intervention (6 months from baseline) ]
  6. Height [ Time Frame: Baseline and after intervention (6 months from baseline) ]
  7. Percentage of body fat [ Time Frame: Baseline and after intervention (6 months from baseline) ]
  8. Waist circumference [ Time Frame: Baseline and after intervention (6 months from baseline) ]

Other Outcome Measures:
  1. Parental information (education and occupation) [ Time Frame: Baseline ]
    Ad-hoc questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The study will include:

  • Female and male adolescents aged 13 to 16 years (inclusive),
  • Who agree to participate and sign the informed consent along with their parents/guardian,
  • Have no physical or psychological condition that would prevent understanding of and participation in the intervention,
  • Are able to participate in the study for six months, and
  • Have an adequate proficiency in the local language.

Exclusion Criteria:

  • Those unable to use a smartphone will be excluded from the study.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Agència de Qualitat i Avaluació Sanitàries
ClinicalTrials.gov Identifier: NCT02930148    
Other Study ID Numbers: 750-PEGASO
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: September 2016
Keywords provided by Agència de Qualitat i Avaluació Sanitàries:
mHealth
adolescents
quasi-experimental study
apps
lifestyles
lifestyles knowledge
dietary behaviour
physical activity
sleeping behaviour
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight