NCT07371637

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Sep 2028

Study Start

First participant enrolled

September 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 28, 2026

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

September 25, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

sleepadolescenthealthy schoolcharge your brainzzzevaluation

Outcome Measures

Primary Outcomes (4)

  • Subjective sleep health

    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

    From the start of the intervention until 6 months after its completion

  • Objective sleep duration

    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.

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

  • Objective sleep quality

    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).

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

  • Subjective Sleep Duration

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

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

Secondary Outcomes (9)

  • 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.

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Charge Your Brainzzz

Control group

NO INTERVENTION

Interventions

Charge Your Brainzzz is a comprehensive health promoting school approach intervention, designed to help Dutch secondary school students improve their sleep and sleep hygiene habits. It is based on the Health Promoting School framework and includes all its four pillars, i.e. (1) an education component, (2) a set of components that focus on involving students' (home) environment, a set of school policy changes related to school start times, schools' digital communication activities and schools' stimulation of daytime physical activity of students, and, lastly, (4) a set of tools that school health professionals can use to facilitate the early detection of potential (future) student sleep problems.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • non-regular Dutch secondary schools / special education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University

Amsterdam, North Holland, 1081HV, Netherlands

Location

Related Links

Study Officials

  • Maartje M van Stralen, PhD

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One group will receive the CYB intervention, while the other group will serve as a control group getting regular Dutch secondary school education
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 25, 2025

First Posted

January 28, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 28, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations