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临床试验/NCT06931847
NCT06931847尚未招募不适用

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

Biocruces Bizkaia Health Research Institute8 个研究点 分布在 8 个国家目标入组 4,000 人开始时间: 2025年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
4,000
试验地点
8
主要终点
Feasibility of the Digitally-Enhanced Program

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Feasibility of the Digitally-Enhanced Program

时间窗: 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.

次要结局

  • Perceived Stress(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)
  • Social skills(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)
  • Healthy eating habits(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)
  • Physical Activity(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)
  • Health Literacy(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)
  • EuroQoL-5D-5L questionnaire(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)
  • 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)

研究者

发起方
Biocruces Bizkaia Health Research Institute
申办方类型
Other Gov
责任方
Sponsor

研究点 (8)

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