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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06931847
Acronym
SUNRISE_2
Enrollment
4000
Registered
2025-04-17
Start date
2025-09-30
Completion date
2028-04-30
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

SUNRISE, adolescents, prevention, healthy behaviour, Digital solutions

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.

Interventions

OTHERSUNRISE 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.

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the Digitally-Enhanced Program18 monthsThis 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.

Secondary

MeasureTime frameDescription
Prevalence and frequency of other nicotine products useThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upDetermined 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
Prevalence and frequency of cannabis useThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upMeasured by the number of cannabis (containing THC) consumption days in the preceding 30 days
Prevalence and frequency of alcohol useThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upAssessed by the number of alcohol use days in the preceding 30 days
Perceived StressThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upMeasured 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.
Frequency of tobacco cigarette smokingThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upDetermined by the number of days on which tobacco cigarettes were smoked in the last 30 days
Healthy eating habitsThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upMeasured 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).
Physical ActivityThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upDetermined 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)
Health LiteracyThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upAssessed 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).
EuroQoL-5D-5L questionnaireThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upScoring from 0-100 points. 0 points low quality of life 100 high quality of life
Social skillsThe secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-upAssessed 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.

Countries

Belgium, Cyprus, Greece, Italy, Romania, Slovenia, Spain, Switzerland

Contacts

Primary ContactEunate Arana-Arri, PhD
eunate.aranaarri@osakidetza.eus+34 944881593
Backup ContactMaitane Barasoain, PhD
maitane.barasoainhernandez@bio-bizkaia.eus+34 946006239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026