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

NCT06931847 | Not Yet Recruiting

• 2 other identifiers: SUNRISE_Study2PI2024216
• Study Type: observational
• Target: 4,000
• Locations: 8 countries
• Sites: 8

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.

Conditions

Cancer

Keywords

SUNRISE; adolescents; prevention; healthy behaviour; Digital solutions

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Digitally-Enhanced Program

  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 Outcomes (10)

• Frequency of tobacco cigarette smoking

  The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

• Prevalence and frequency of other nicotine products use

  The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

• Prevalence and frequency of cannabis use

  The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

• Prevalence and frequency of alcohol use

  The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

• Perceived Stress

  The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Study Arms (2)

Control

No intervention

Intervention

SUNRISE program

Other: SUNRISE program

Interventions

SUNRISE program OTHER

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.

Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

Ghent University (UGENT)

Zürich, 9000, Belgium

Location

Cyprus Association of Cancer Patients and Friends (PASYKAF)

Nicosia, 1687, Cyprus

Location

Hellenic Mediterranean University (HMU)

Heraklion, 71410, Greece

Location

Italian Federation of Voluntary Associations in Oncology (FAVO)

Roma, 00187, Italy

Location

Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)

Cluj-Napoca, 4547125, Romania

Location

Alma Mater Europaea University (AMEU)

Maribor, 2000, Slovenia

Location

Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio)

Valencia, 46010, Spain

Location

Swiss Research Institute for Public Health and Addiction (ISGF)

Zurich, 8005, Switzerland

Location

Related Publications (6)

• De Jans S, Spielvogel I, Naderer B, Hudders L. Digital food marketing to children: How an influencer's lifestyle can stimulate healthy food choices among children. Appetite. 2021 Jul 1;162:105182. doi: 10.1016/j.appet.2021.105182. Epub 2021 Mar 3.

  PMID: 33667499 BACKGROUND

• Haug S, Paz Castro R, Wenger A, Schaub MP. A Mobile Phone-Based Life-Skills Training Program for Substance Use Prevention Among Adolescents: Cluster-Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Jul 13;9(7):e26951. doi: 10.2196/26951.

  PMID: 34255703 BACKGROUND

• Bailey JV, Murray E, Rait G, Mercer CH, Morris RW, Peacock R, Cassell J, Nazareth I. Interactive computer-based interventions for sexual health promotion. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD006483. doi: 10.1002/14651858.CD006483.pub2.

  PMID: 20824850 BACKGROUND

• Maher CA, Lewis LK, Ferrar K, Marshall S, De Bourdeaudhuij I, Vandelanotte C. Are health behavior change interventions that use online social networks effective? A systematic review. J Med Internet Res. 2014 Feb 14;16(2):e40. doi: 10.2196/jmir.2952.

  PMID: 24550083 BACKGROUND

• O'Keeffe GS, Clarke-Pearson K; Council on Communications and Media. The impact of social media on children, adolescents, and families. Pediatrics. 2011 Apr;127(4):800-4. doi: 10.1542/peds.2011-0054. Epub 2011 Mar 28.

  PMID: 21444588 BACKGROUND

• Colditz GA, Wei EK. Preventability of cancer: the relative contributions of biologic and social and physical environmental determinants of cancer mortality. Annu Rev Public Health. 2012 Apr;33:137-56. doi: 10.1146/annurev-publhealth-031811-124627. Epub 2012 Jan 3.

  PMID: 22224878 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Eunate Arana-Arri, PhD

CONTACT

+34 944881593; eunate.aranaarri@osakidetza.eus

Maitane Barasoain, PhD

CONTACT

+34 946006239; maitane.barasoainhernandez@bio-bizkaia.eus

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: April 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); CH (1); RO (1); ES (1); CY (1); IT (1); GR (1); SL (1)