SUNRISE Aims to Create a Comprehensive, Engaging, and Sustainable Digital Health Promotion Program That Not Only Addresses Immediate Health Behaviours But Also Instils Lifelong Healthy Habits Among Adolescents. It is a Unique, Digitally Enhanced Program Combining Different Digital Solutions With New (SUNRISE_2)

April 9, 2025 updated by: Biocruces Bizkaia Health Research Institute

SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 2: Multiple Behaviour Intervention Platform

SUNRISE aims to create a comprehensive, engaging, and sustainable digital health promotion program that not only addresses immediate health behaviours but also instills lifelong healthy habits among adolescents. By integrating cutting-edge digital tools with traditional educational settings, SUNRISE seeks to bridge the gap between knowledge and practice, making cancer prevention a tangible and achievable goal for young people. This study represents a significant step towards reducing the future burden of cancer through early and innovative preventive measures.

The SUNRISE project aims to test its interventions on students across eight European countries, including Greece, Switzerland, Slovenia, Spain, Cyprus, Italy, Belgium, and Romania. This study focuses on integrating a unique, digitally enhanced program combining different digital solutions with new methods to change adolescent health behaviour through social media campaigns, social bot platforms, educational games, and health-related advertising content into the school environment, targeting students aged 10 to 19 years.

The program emphasizes inclusivity, ensuring participation from both urban and rural regions and socially disadvantaged groups such as ethnic minorities and migrants. By addressing diverse socio-economic, cultural, and environmental contexts, SUNRISE aspires to create a universally applicable and impactful intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer remains one of the leading causes of death globally, with significant potential for prevention through early adoption of healthy behaviours. Adolescence is a crucial period for establishing such behaviours, and digital interventions offer a promising avenue for promoting sustained health behaviour changes. The SUNRISE project is dedicated to enhancing primary cancer prevention among adolescents in Europe by leveraging innovative digital tools and methodologies.

The Study 2 of the SUNRISE project aims to test its interventions on 4,000 students across eight European countries, including Greece, Switzerland, Slovenia, Spain, Cyprus, Italy, Belgium, and Romania. This study focuses on integrating digitally enhanced programs into the school environment, targeting students aged 10 to 19 years. The program emphasizes in inclusivity, ensuring participation from both urban and rural regions and socially disadvantaged groups such as ethnic minorities and migrants. By addressing diverse socio-economic, cultural, and environmental contexts, SUNRISE aspires to create a universally applicable and impactful intervention.

Adolescence is a period of significant biological, psychological, and social transitions, presenting both opportunities for skill development and risks for harmful behaviours. Substance use often begins during this time, with increased prevalence of alcohol, tobacco, and cannabis consumption as teenagers' age. Furthermore, adolescents are highly susceptible to influences from their social environment, including peers and media. Social media platforms and influencers play a significant role in shaping their attitudes and behaviours, making it essential to leverage these tools to promote healthy behaviours and critical thinking. Schools are ideal settings for preventive interventions due to their accessibility to young people. Platforms like WhatsApp, YouTube, and TikTok offer powerful spaces to reach and engage adolescents, providing interactive functionalities that can impact their health positively. Health behaviour change interventions using social media have shown modest evidence of effectiveness, highlighting the need for further research to target adolescents and ensure the sustainability of behaviour changes in the long term.

SUNRISE sets itself apart from other studies by employing a comprehensive, multi-faceted approach that integrates various digital tools tailored to the specific needs of adolescents. Unlike traditional health promotion programs, which often face challenges in resource allocation and educator support, SUNRISE leverages digital platforms to provide cost-effective, engaging, and personalized interventions. This approach not only makes health information more accessible but also ensures continuous engagement through platforms that adolescents already use for leisure.

The intervention will include a variety of digital tools designed to promote cancer prevention behaviours. These tools will be tailored to the needs of each school through authoring and monitoring platforms, enabling educators to adapt the content and delivery methods. The primary digital solutions include:

  • SmartCoach: This mobile-based life-skills training program is designed to prevent substance use by sending tailored messages focusing on self-management, social skills, and substance use resistance. These messages are delivered 2-4 times a week and are integrated with social media platforms to enhance engagement and reach.
  • Innovative Social Robots and Conversational Assistants: These tools interact with adolescents through voice commands, offering personalized responses and motivational support. They employ quizzes and persuasive multimedia content to assess and influence health behaviours in areas like diet, physical activity, and advertising literacy.
  • Educational and Serious Games: Interactive games designed to improve health knowledge and behaviour. These games are accessible via mobile devices and include scenarios that teach adolescents about the risks of unhealthy food advertising and other health-related topics.
  • Influencer Campaigns: Co-created with adolescents, nutrition experts, and influencers, these campaigns aim to combat nutritional misinformation on social media. Influencers will create and share content designed to improve adolescents' understanding and critical evaluation of health information online.
  • Health and Advertisement Educational Module: This module uses interactive content such as videos and quizzes to educate adolescents on healthy eating and the tactics used in advertising. It aims to enhance their ability to critically evaluate health messages and make informed decisions.

The implementation of these interventions will be closely monitored and evaluated to assess their effectiveness and sustainability. This will involve statistical analysis of individual outcomes, focus groups, semi-structured interviews with parents, educators, and students, and cost-effectiveness analysis to predict long-term health and economic impacts. The evaluation process is designed to capture a comprehensive picture of how the interventions influence behaviour, well-being, and overall health literacy among adolescents. In addition, PARTICLE.TALK social media platform can collect details of the participants' interaction and its evolution as the study evolves to better support the monitoring and evaluation phases of the study.

SUNRISE aims to create a comprehensive, engaging, and sustainable digital health promotion program that not only addresses immediate health behaviours but also instils lifelong healthy habits among adolescents. By integrating cutting-edge digital tools with traditional educational settings, SUNRISE seeks to bridge the gap between knowledge and practice, making cancer prevention a tangible and achievable goal for young people. This study represents a significant step towards reducing the future burden of cancer through early and innovative preventive measures.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Zürich, Belgium, 9000
        • Ghent University (UGENT)
        • Contact:
        • Contact:
        • Contact:
          • Liselot Hudders, PhD
        • Contact:
          • Hayle Pearce
        • Contact:
          • Dieneke Van de Sompel
  • Cyprus
      • Nicosia, Cyprus, 1687
        • Cyprus Association of Cancer Patients and Friends (PASYKAF)
        • Contact:
        • Contact:
        • Contact:
          • Maria Krini, PhD
        • Contact:
          • Teophano Pampaka
  • Greece
      • Heraklion, Greece, 71410
        • Hellenic Mediterranean University (HMU)
        • Contact:
        • Contact:
        • Contact:
          • Kleio Koutra, PhD
        • Contact:
          • Vassilis Kilintzis
  • Italy
      • Roma, Italy, 00187
        • Italian Federation of Voluntary Associations in Oncology (FAVO)
        • Contact:
        • Contact:
        • Contact:
          • Chiara Pilotti
        • Contact:
          • Laura Del Campo
        • Contact:
          • Rosalia Lombardi
  • Romania
      • Cluj-Napoca, Romania, 4547125
        • Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)
        • Contact:
        • Contact:
        • Contact:
          • Delia Nicoara, Dr.
        • Contact:
          • Nina Nicoara
  • Slovenia
  • Spain
      • Valencia, Spain, 46010
        • Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio)
        • Contact:
        • Contact:
        • Contact:
          • Ana Molina-Barceló, PhD
        • Contact:
          • Teresa De Pablo-Pardo
        • Contact:
          • Mireia Gandía
  • Switzerland
      • Zürich, Switzerland, 8005
        • Swiss Research Institute for Public Health and Addiction (ISGF)
        • Contact:
        • Contact:
        • Contact:
          • Severin Haug, PhD
        • Contact:
          • Nikolai Kiselev, PhD
        • Contact:
          • Niko Boumparis
        • Contact:
          • Andreas Wenger, M.Sc.
        • Contact:
          • Jeannine Jaggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Secondary and upper secondary students between 10 and 19 years old (at time of recruitment), who are freely willing to participate in the study.

Description

Inclusion Criteria:

  • Minimum Age: Students must be at least 10 years old at the time of enrolment.
  • Devices and Internet Access: Students must have access to an electronic device with Internet connectivity.
  • Informed Consent: Students must provide their signed informed consent to participate in the study.
  • Parental Consent: Students, when necessary, must obtain and submit signed informed consent from a parent or legal guardian.

Exclusion Criteria:

  • Age Restrictions: Students who are younger than 10 years or older than the established age range for participation.
  • Consent Issues: Students who have not signed the informed consent form or do not have signed informed consent from their parents or legal guardians.
  • Follow-up Limitations: Students who are unable to commit to the follow-up period of at least 18 months or are unlikely to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
No intervention
Intervention
SUNRISE program
Other: SUNRISE program

The program will use several solutions, each focusing on different aspects of health promotion:

  • SmartCoach, a mobile phone-based life-skills training program, focuses on self-management, social skills, and substance use resistance.
  • Social robots and conversational assistants aim to engage students through interactive sessions on health topics like diet and physical activity.
  • Educational and serious games enhance knowledge and resistance to unhealthy food marketing, providing an engaging way to learn about advertising tactics and healthy eating.
  • The influencer campaign tackles nutritional misinformation by using content created by influencers to educate adolescents on detecting and critically evaluating misleading health information.
  • Health and advertisement educational module aims to educate students on recognizing deceptive advertising and making informed choices about their health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Digitally-Enhanced Program
Time Frame: 18 months
This will be measured by evaluating the usage and engagement with the intervention, through a in-house authoring and monitoring tool. This tool will include the questionnaires, statistical displays, interactive visualization of data and reporting tools for monitoring and assessment of the intervention outcomes.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of tobacco cigarette smoking
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Determined by the number of days on which tobacco cigarettes were smoked in the last 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of other nicotine products use
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Determined by the number of days on which other nicotine products, e.g., vape, e-cigarette, e-shisha, snus or nicotine pouches, were consumed in the last 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of cannabis use
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Measured by the number of cannabis (containing THC) consumption days in the preceding 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of alcohol use
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Assessed by the number of alcohol use days in the preceding 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Perceived Stress
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Measured using the 4-item version of the Perceived Stress Scale (PSS-4): The questions in this scale ask about the feelings and thoughts during the last month. In each case, the response represents how often participant felt or thought a certain way.

Scoring Instructions:

Total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded.

Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often Lowest score: 0; Highest score: 16. Higher scores are correlated to more stress.
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Social skills
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Assessed utilizing the brief version of the Interpersonal Competence Questionnaire-10 (ICQ-10), which encompasses the following 5 domains: (1) initiation of relationships, (2) negative assertions, (3) disclosure of personal information, (4) emotional support, and (5) conflict management.

Scoring instructions: Good=4; Fairly good= 3; Rather poor=2; Poor=1. Total score is determined by adding the value of all items and dividing by 2. Maximum value= 20; Minimum value= 5. The higher the score, the higher the interpersonal competence.
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Healthy eating habits
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Measured using the WHO/HBSC eating habits questionnaire. Label values: 1 = never, 2 = Less than once a week, 3 = Once a week, 4 = 2-4 days a week, 5 = 5-6 days a week, 6 = Once a day (Every day), 7 = Every Day (more than once).
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
EuroQoL-5D-5L questionnaire
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Scoring from 0-100 points. 0 points low quality of life 100 high quality of life
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Physical Activity
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Determined by 2 questions:

  • Over the past 7 days, on how many days were you physically active for a total of at least 60 minutes per day? (0 days - 7 days)
  • Outside school hours: how often do you usually exercise in your free time so much that you get out of breath or sweat? (Every day; 4 to 6 times a week; 2 to 3 times a week; Once a month; Less than once a month; Never)
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Health Literacy
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Assessed utilizing the HLS-EU-Q16 Scale that measures health literacy in three domains: health care (seven items), disease prevention (five items) and health promotion (four items). Each question of HLS-EU-Q16 was answered by choosing one response of the available choices: 'very difficult', 'fairly difficult', 'fairly easy' and 'very easy'. Each of the 16 questions were coded according to the following: 'very difficult' = 1 point, 'fairly difficult' = 2 points, 'fairly easy' = 3 points or 'very easy' = 4 points, giving a total of 16-64 scores. The HLS-EU-Q16 manual recommends dichotomising the answers from HLS-EU-Q16 ('very difficult'/'fairly difficult' = 0, 'fairly easy'/'very easy' = 1; total 0-16 scores) and dividing the total scores into three categories ('likely inadequate HL '(0-8 scores), 'likely problematic HL' (9-12 scores) and 'likely sufficient HL' (13-16 scores).
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocruces Bizkaia Health Research Institute

Collaborators

University of Zurich
University Ghent
FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA
Hellenic Mediterranean University
FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
Cyprus Association of Cancer Patients and Friends (PASYKAF)
Alma Mater Europaea University
The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUNRISE_Study2
  • PI2024216 (Other Identifier: Comité de Ética de la Investigación con medicamentos de Euskadi (CEIm-E))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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