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

NCT02930148 | Unknown

• 1 other identifier: 750-PEGASO
• Study Type: interventional
• Target: 525
• Locations: 0 countries
• Sites: N/A

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. 1.To test the usability of PEGASO platform
2. 2.To pilot approaches to testing the effectiveness of the system to:
3. 3.Evaluate the increase of knowledge/awareness about healthy habits
4. 4.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

Keywords

mHealth; adolescents; quasi-experimental study; apps; lifestyles; lifestyles knowledge; dietary behaviour; physical activity; sleeping behaviour

Outcome Measures

Primary Outcomes (11)

• Change in dietary habits

  Mediterranean Diet Quality Index for children and teenagers (KIDMED) questions

  Baseline and after intervention (6 months from baseline)

• Change in physical activity

  The Physical Activity Questionnaire for Adolescents (PAQ-A)

  Baseline and after intervention (6 months from baseline)

• Change in sedentary behaviour

  The Screen time-based sedentary behaviour questionnaire (SSBQ) from the HELENA study

  Baseline and after intervention (6 months from baseline)

• Change in sleeping habits

  Sleep Habits Survey for Adolescents (SHSA)

  Baseline and after intervention (6 months from baseline)

• Change in lifestyles knowledge questionnaire

  Ad hoc questionnaire on lifestyle knowledge

  Baseline and after intervention (6 months from baseline)

• Change in user experience of the PEGASO system

  Ad-hoc interviews pro-forma to assess user experience

  4 and 6 months after baseline

• Change in the usability of the system

  System Usability Scale (SUS questionnaire)

  2, 4 and 6 months after baseline

• Change in the emotions when using the system

  Emotional Metric Outcomes questionnaire

  4 and 6 months after baseline

• Change in satisfaction when using the system

  Ad-hoc questionnaire for satisfaction

  4 and 6 months after baseline

• Change in dietary habits

  Ad-hoc questionnaire

  Baseline and after intervention (6 months from baseline)

• Change in physical activity

  Ad-hoc questionnaire

  Baseline and after intervention (6 months from baseline)

Secondary Outcomes (8)

• Self-perceived health status

  Baseline and after intervention (6 months from baseline)

• Motivation

  Baseline and month 2, 4 and 6 after baseline

• Habit

  Continous data collection from month 1 to month 6 with data extraction at month 6 for analysis

• Self-awareness

  Continous data collection from month 1 to month 6 with data extraction at month 6 for analysis

• Weight

  Baseline and after intervention (6 months from baseline)

Other Outcomes (1)

• Parental information (education and occupation)

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Comparative

NO INTERVENTION

Participants will be asked to continue their routine daily physical and educational activities related to leading a healthy lifestyle.

Interventions

PEGASO System (ICT based system/mHealth solution) OTHER

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

Intervention

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Those unable to use a smartphone will be excluded from the study.

Sponsors & Collaborators

• Agència de Qualitat i Avaluació Sanitàries: lead
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator
• Politecnico di Milano: collaborator
• University of Nottingham: collaborator
• University of Edinburgh: collaborator

Related Publications (2)

• Caon M, Prinelli F, Angelini L, Carrino S, Mugellini E, Orte S, Serrano JCE, Atkinson S, Martin A, Adorni F. PEGASO e-Diary: User Engagement and Dietary Behavior Change of a Mobile Food Record for Adolescents. Front Nutr. 2022 Mar 17;9:727480. doi: 10.3389/fnut.2022.727480. eCollection 2022.

  PMID: 35369096 DERIVED

• Puigdomenech E, Martin A, Lang A, Adorni F, Gomez SF, McKinstry B, Prinelli F, Condon L, Rashid R, Caon M, Atkinson S, Lafortuna CL, Ciociola V, Hanley J, McCloughan L, Castell C, Espallargues M; PEGASO Fit For Future Consortium. 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. BMC Med Inform Decis Mak. 2019 Dec 17;19(1):278. doi: 10.1186/s12911-019-0958-x.

  PMID: 31847919 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 12, 2016

Record last verified: 2016-09