Clinical trial · Interventional
The SUNRISE Project is Dedicated to Enhancing Primary Cancer Prevention Among Adolescents in Europe by Leveraging Innovative Digital Tools and Methodologies. SmartCoach, Developed by Swiss Research Institute for Public Health and Addiction (ISGF), is a Mobile Phone-based Life-skills Training Program
SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 1: SmartCoach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 intervention on 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 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. Specifically, this study is focus on the SmartCoach program, developed by the Swiss Research Institute for Public Health and Addiction (ISGF). It is a mobile phone-based life-skills training program designed to prevent substance use among adolescents. It will integrate digital tools and leveraging social media creating a more engaging, effective and sustainable intervention for adolescent health behaviour change. The SmartCoach solution will be significantly more effective than an assessment-only approach in preventing the initiation and escalation of problematic alcohol and tobacco use. This efficacy will be demonstrated through a two-arm cluster-randomized controlled trial, with participants assessed at baseline, 6 months, and 18 months. The study will measure key outcomes related to substance use frequencies, intensities, and associated behavioral changes, showing that the individually tailored 4 month intervention program leads to greater reductions in these behaviors compared to the control group over the 18-month follow-up period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartCoach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- No intervention
- type
- EXPERIMENTAL
- label
- Intervention
- description
- SmartCoach program
- interventionNames
- Other: SmartCoach
Primary outcomes (1)
- measure
- Point prevalence rate of tobacco or nicotine use
- timeFrame
- The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up
- description
- This will be measured by assessing the rate of abstinence (not even smoked a puff or used once) from tobacco or nicotine products in the preceding 30 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Minimum Age: Students must be at least 14 years old at the time of enrolment. * Mobile Device and Internet Access: Students must have access to a smartphone and the Internet. * Informed Consent: Students must provide their signed informed consent to participate in the study. * Parental Consent: Students must obtain and submit signed informed consent from a parent or legal guardian. Exclusion Criteria: * Age Restrictions: Students who are younger than 14 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.
References
Publications (13)
- BACKGROUNDMaher 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
- BACKGROUNDBandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660. PMID 15090118
- BACKGROUNDHaug S, Schaub MP, Venzin V, Meyer C, John U. Efficacy of a text message-based smoking cessation intervention for young people: a cluster randomized controlled trial. J Med Internet Res. 2013 Aug 16;15(8):e171. doi: 10.2196/jmir.2636. PMID 23956024
- BACKGROUNDStockings E, Hall WD, Lynskey M, Morley KI, Reavley N, Strang J, Patton G, Degenhardt L. Prevention, early intervention, harm reduction, and treatment of substance use in young people. Lancet Psychiatry. 2016 Mar;3(3):280-96. doi: 10.1016/S2215-0366(16)00002-X. Epub 2016 Feb 18. PMID 26905481
- BACKGROUNDThomas RE, McLellan J, Perera R. School-based programmes for preventing smoking. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD001293. doi: 10.1002/14651858.CD001293.pub3. PMID 23633306
- BACKGROUNDHaug 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
- BACKGROUNDChampion KE, Parmenter B, McGowan C, Spring B, Wafford QE, Gardner LA, Thornton L, McBride N, Barrett EL, Teesson M, Newton NC; Health4Life team. Effectiveness of school-based eHealth interventions to prevent multiple lifestyle risk behaviours among adolescents: a systematic review and meta-analysis. Lancet Digit Health. 2019 Sep;1(5):e206-e221. doi: 10.1016/S2589-7500(19)30088-3. Epub 2019 Aug 19.