SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 1: SmartCoach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,500
- 试验地点
- 16
- 主要终点
- Point prevalence rate of tobacco or nicotine use
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 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.
详细描述
Cancer is a leading cause of death worldwide, responsible for an estimated 9.9 million deaths in 2020. Many cancers can currently be prevented by avoiding risk factors, implementing evidence-based prevention strategies, and adopting healthy behaviours. Adolescence is a critical period for establishing these behaviours, as many risk behaviours such as smoking and poor diet begin at this stage. Despite numerous school-based interventions, significant gaps remain in achieving sustainable health behaviour changes among adolescents.
The SUNRISE project aims to bridge these gaps and reduce social inequalities in primary cancer prevention among adolescents in Europe. Traditional health promotion programs face barriers such as the need for extensive resources and continuous support for educators. Digital interventions offer a promising solution by providing cost-effective, engaging, and tailored content accessible 24/7. As part of its comprehensive approach, SUNRISE seeks to test various innovative solutions, including the SmartCoach program, to determine the most effective strategies for adolescent health promotion.
SmartCoach, developed by Swiss Research Institute for Public Health and Addiction (ISGF), is a mobile phone-based life-skills training program designed to prevent substance use among adolescents. It has shown significant long-term effectiveness in reducing tobacco smoking and cannabis use. Based on Social Cognitive Theory, SmartCoach promotes self-management skills, social skills, and substance use resistance through tailored weekly text messages over a period of several months.
Adolescence is a period of significant biological, psychological, and social transitions. These transitions provide opportunities for skill development but also present risks for developing harmful behaviours. Substance use often begins during adolescence, with increased prevalence of alcohol, tobacco, and cannabis consumption as teen's age. For instance, the Health Behaviour in School-aged Children (HBSC) study showed noticeable increases in the lifetime prevalence of these substances among 11-to-15-year-olds. Schools are ideal settings for delivering preventive interventions due to their accessibility to young people.
Life-skills training programs, which focus on self-management, social skills, and substance use resistance, have proven effective but face challenges in implementation and sustainability. Traditional face-to-face interventions require substantial resources and commitment from educators. Digital interventions, such as those delivered via mobile phones, can overcome these obstacles by providing flexible, engaging, and tailored content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Point prevalence rate of tobacco or nicotine use
时间窗: The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up
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.
次要结局
- 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 alcohol 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)
- 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)
- EuroQoL-5D-5L questionnaire(The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up)