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临床试验/NCT07371637
NCT07371637进行中(未招募)不适用

Charge Your Brainzzz: Evaluation of an Integrated Approach to Improve Teenagers' Sleep Health

VU University of Amsterdam1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,200
试验地点
1
主要终点
Subjective sleep health

研究概览

简要总结

Poor sleep among teenagers is a major public health issue. Studies show that in the Netherlands, nearly half of adolescents don't wake up feeling rested, one in five feel sleepy during the day, one in four regularly wake up at night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended 8-10 hours per night. Over the past decade, teenagers' average sleep time has dropped by about 40 minutes.

Good sleep health means having a regular sleep rhythm with about 8-10 hours of quality sleep each night. This is crucial, because poor sleep in teenagers can lead to problems with thinking, learning, concentration, and school performance. In the long run, it also increases the risk of serious health issues such as anxiety, depression, obesity, diabetes, cardiovascular disease, and even dementia.

Because of these risks, schools, municipalities, and public health services are calling for effective ways to prevent sleep problems among teenagers. The Dutch "Healthy School" program has recently added sleep as a core theme, but proven, practical interventions are still lacking.

To address this gap, the Charge Your Brainzzz (CYB) program was developed. CYB is a comprehensive approach designed to help secondary school students improve their sleep and mental well-being. It is based on the Healthy School framework and includes all four pillars: education, environment, policy, and early detection.

In 2024, a pilot study tested the CYB approach for its initial effectiveness and suitability. Early results showed positive changes in sleep outcomes and strong appreciation from both schools and students. However, before CYB can be rolled out nationwide, more evidence is needed on its effectiveness, fit with schools, and how it can be sustained over time.

That's why this project will conduct a large-scale evaluation of both the impact of CYB and the processes needed for successful implementation. Alongside the effectiveness study, a practical roadmap will be co-created with schools, Healthy School Advisors, and local coordinators to ensure that CYB can be optimally implemented, sustained, and scaled up across schools, municipalities, and public health services across the Dutch public health landscape.

详细描述

Poor sleep health among adolescents is a major public health problem. In the Netherlands, nearly half of adolescents report not waking up feeling rested, one in five say they feel sleepy during the day, one in four regularly do not sleep through the night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended 8-10 hours per night. Over the past ten years, adolescents' average sleep duration has decreased by about 40 minutes.

Sleep health refers to maintaining a regular sleep rhythm of approximately 8-10 hours of good-quality sleep per night. Sleep health is extremely important, because when teenagers sleep poorly, they may experience declines in cognition, learning ability, concentration, and school performance. Moreover, poor sleep in adolescence increases the risk of long-term health problems such as anxiety and depression, obesity, diabetes, cardiovascular disease, and dementia.

From both research and the practical experience of schools, municipalities, and public health services, there is a strong demand for effective interventions to address these problems through prevention among teenagers. The Dutch "Healthy School" program (Gezonde School) shares this sense of urgency and has recently added sleep as a core theme. However, proven effective interventions for practice are still lacking.

To fill this gap, the integrated Charge Your Brainzzz (CYB) approach was recently developed to support secondary school students in improving their sleep and mental well-being. The approach is based on the Healthy School framework, with well-substantiated applications of all four Healthy School pillars: Education, Environment, Policy, and Early Detection.

In 2024, a pilot study was conducted to evaluate the initial effectiveness and suitability of the CYB approach (Pilot Study results in draft, 2025). Preliminary results from this pilot evaluation showed positive changes in sleep outcomes and strong appreciation from both schools and adolescents. However, before schools, municipalities, and public health services can implement CYB nationwide within the Healthy School framework, it is important to establish clarity about the program's effectiveness, appropriateness, sustainability processes, and, above all, its efficacy. Therefore, a sufficiently large, controlled evaluation study is needed to assess both effectiveness in practice and the processes of implementation and sustainability.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Dutch regular secondary schools that include at least one vocational track (VMBO)
  • First-year students enrolled in the VMBO tracks of participating schools
  • Teachers, school health professionals, school care coordinators, school management, and the regional municipal health service's (GGD) Healthy School advisors who work with at least one of the participating schools

排除标准

  • non-regular Dutch secondary schools / special education

研究组 & 干预措施

Intervention group

Experimental

干预措施: Charge Your Brainzzz (Behavioral)

Control group

No Intervention

结局指标

主要结局

Subjective sleep health

时间窗: From the start of the intervention until 6 months after its completion

Subjective sleep health will be assessed using a concise questionnaire that comprehensively covers the submeasures (1) sleep duration, (2) sleep quality, (3) sleep efficiency, (4) bedtime routines/sleep hygiene, (5) sleep timing, and (6) daytime sleepiness \[1,2\]. In addition to sleep health, the most relevant behavioral determinants will be measured at each assessment point, alongside the direct targets of the CYB program. These include, for example, the presence of household rules regarding bedtimes and wake-up times, as well as adolescents' sleep hygiene practices, with particular attention to evening screen use and the presence of a mobile phone in the bedroom at night. Time frame of data collection: prior to implementation of the program (T0), within two weeks after completion of the educational component, (T1), and at six-month follow-up after T1 (T2). 1. Buysse (2014). https://doi.org/10.5665/sleep.3298 2. Meltzer (2021). https://doi.org/10.1016/j.smrv.2021.101425

Objective sleep duration

时间窗: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.

A random selection of approximately two classes per participating school will wear GeneActiv sleep monitors during the three measurement periods (T0, T1, T2) to objectively assess sleep duration and sleep quality. These sleep monitors will be worn continuously on the wrist for a period of five weekdays. These devices measure the activity pattern, temperature, and ambient light surrounding the student wearing them.

Objective sleep quality

时间窗: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.

A random selection of approximately two classes per participating school will wear GeneActiv sleep monitors during the three measurement periods (T0, T1, T2) to objectively assess sleep duration and sleep quality. These sleep monitors will be worn continuously on the wrist for a period of five weekdays. These devices measure the activity pattern, temperature, and ambient light surrounding the student wearing them. Additionally, during these days, students will complete a sleep diary each morning (approximately 5 minutes).

Subjective Sleep Duration

时间窗: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.

All participating students will complete a sleep diary each morning (approximately 5 minutes) in which they report their sleep duration.

次要结局

  • Students' knowledge on healthy sleep(Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.)
  • Students' attitude towards sleep health(Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.)
  • Students' self-efficacy in relation to their sleep health(Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.)
  • Students' subjective norms in relation to sleep health of their peers and parents(Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.)
  • Students' behavioral intention to sleep healthier(Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.)
  • Students' sleep hygiene practices(Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.)
  • Appreciation and acceptance of the intervention(In the first school year following the start of the implementation of the program (T1), and again six months later (T2))
  • Facilitators and barriers in relation to the intervention's adoption, implementation and sustainment(In the first school year following the start of the implementation of the program (T1), and again six months later (T2))
  • Ripple effects mapping(Every 4 months after the start of the intervention's implementation)

研究者

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maartje van Stralen

Associate Professor

VU University of Amsterdam

研究点 (1)

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