Clinical trial NCT06931847: 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
Official title: SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 2: Multiple Behaviour Intervention Platform
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: SUNRISE
adolescents
prevention
healthy behaviour
Digital solutions
Lead sponsor: Biocruces Bizkaia Health Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA
name: Hellenic Mediterranean University
name: University Ghent
name: University of Zurich
name: FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
name: The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca
name: Cyprus Association of Cancer Patients and Friends (PASYKAF)
name: Alma Mater Europaea University
First posted: 2025-04-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the Digitally-Enhanced Program
timeFrame: 18 months
Secondary outcomes:
measure: Frequency of tobacco cigarette smoking
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Prevalence and frequency of other nicotine products use
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Prevalence and frequency of cannabis use
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Prevalence and frequency of alcohol use
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Perceived Stress
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Social skills
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Healthy eating habits
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Physical Activity
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Health Literacy
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: EuroQoL-5D-5L questionnaire
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Other outcomes:
Locations:
city: Zürich
country: Belgium
facility: Ghent University (UGENT)
city: Nicosia
country: Cyprus
facility: Cyprus Association of Cancer Patients and Friends (PASYKAF)
city: Heraklion
country: Greece
facility: Hellenic Mediterranean University (HMU)
city: Roma
country: Italy
facility: Italian Federation of Voluntary Associations in Oncology (FAVO)
city: Cluj-Napoca
country: Romania
facility: Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)
city: Maribor
country: Slovenia
facility: Alma Mater Europaea University (AMEU)
city: Valencia
country: Spain
facility: Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio)
city: Zürich
country: Switzerland
facility: Swiss Research Institute for Public Health and Addiction (ISGF)
Study officials:
References:
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