Condition category
Mental and Behavioural Disorders
Date applied
29/10/2019
Date assigned
08/11/2019
Last edited
05/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Inadequate sleep is widespread among adolescents and many studies report a decrease in their sleep duration and quality. Short sleep duration and quality have a negative impact on learning ability, memory and concentration, and consequently school performance. Sleep deprivation also has other mental and physical consequences. Schools can be an appropriate setting for programs that promote healthy sleep in adolescents, as school-based programs were already found to be successful for other health-related behaviors such as physical activity and obesity. The context of school provides an environment for learning and a large part of the youth population can be reached. However, effective programs that focus on sleep are currently lacking in the Netherlands. For this purpose, the school-based educational program ‘Charge Your Brainzzz’ was developed by the Dutch Brain Foundation (Hersenstichting Nederland) to promote healthy sleeping in Dutch adolescents by improving knowledge and attitudes towards sleep and sleep hygiene practices. The program consists of three sleep-education lessons and a serious game provided as homework. The aim of this study is to examine the effectiveness of the Charge Your Brainzzz intervention on adolescents' sleep duration and sleep quality. Also, changes in adolescents’ sleep hygiene and behavioral determinants are examined.

Who can participate?
Second- and third- grade students at participating high schools

What does the study involve?
Schools are randomly allocated to either the intervention or control group. The intervention group participate in the Charge Your Brainzzz program, while control groups do not participate in the program. Both groups are asked to fill in a sleep diary and a questionnaire at three points in time. The study lasts about 4 months. By participating in the study, classes can win a group excursion.

What are the possible benefits and risks of participating?
Students could improve their sleep behavior while being exposed to the intervention. In addition, school classes could win a group excursion when participating in this study. Five group excursions will be raffled in this trial. Students’ awareness regarding sleep behavior could increase when participating in this study, which may lead to undesired changes in thoughts on sleep behavior. However, this risk is considered minimal.

Where is the study run from?
Vrije Universiteit Amsterdam and the Municipal Health Service Amsterdam (Netherlands)

When is the study starting and how long is it expected to run for?
March 2018 to February 2019

Who is funding the study?
The Dutch Brain Foundation (Hersenstichting) (Netherlands)

Who is the main contact?
Drs. M.M.R. Inhulsen
m.m.r.inhulsen@vu.nl

Trial website

Contact information

Type

Scientific

Primary contact

Miss Maj-Britt Inhulsen

ORCID ID

Contact details

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
+31 (0)205984301
m.m.r.inhulsen@vu.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

WC2017-093

Study information

Scientific title

Mixed methods evaluation of a school-based intervention promoting sleep in adolescents: a cluster-randomized controlled trial

Acronym

Study hypothesis

It is hypothesized that the intervention is effective in improving sleep behavior (i.e. sleep duration and sleep quality), sleep hygiene and behavioral determinants (i.e. knowledge, attitude, subjective norm, self-efficacy and intention).

Ethics approval

The study was evaluated on 28/05/2018 by the Medical Ethical Committee of the Amsterdam UMC (VUmc) (BS7, room H-443, Postbus 7057, 1007 MB Amsterdam, Netherlands; Tel: +31 (0)204445585; Email: metc@vumc.nl). They decided official approval was not required for this study as the Medical Research Involving Human Subject Acts (WMO) did not apply (ref: 2018.248). Active written consent from students and their parents or caretakers are necessary prior to enrolment in the study.

Study design

Single-centre interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request participant information sheet.

Condition

Sleep behavior (i.e. sleep duration and sleep quality), sleep hygiene and behavioral determinants (i.e. knowledge, attitude, subjective norm, self-efficacy and intention)

Intervention

After agreement to participate, high schools are allocated to either the intervention or control group by matching based on educational level and number of participating classes within a school. Blinding was not possible as the intervention is an educational program carried out by teachers.

The intervention is the school-based educational program 'Charge Your Brainzzz', which consists of three lessons and a serious game provided as homework. The control schools will not receive the intervention.

Both groups are asked to fill in a sleep diary and a questionnaire at baseline, post intervention (max. 2 weeks after intervention) and follow-up (+/- 3 months after the intervention). The study lasts approximately 4 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline, post intervention (max. 2 weeks after intervention) and follow-up (+/- 3 months after the intervention)
1. Sleep duration and sleep quality, measured by a 7-day digital sleep diary, based on the validated Consensus Sleep Diary
2. Sleep hygiene practices, sleep reduction and behavioral determinants (i.e. knowledge, attitude, subjective norm, self-efficacy and intention), measured by a digital questionnaire

Secondary outcome measures

1. Students' acceptance and appreciation of the intervention measured by a digital questionnaire (only for the intervention group) at follow-up (+/- 3 months after the intervention)
2. Qualitative data on implementation processes, obtained by interviews with participating teachers from the intervention schools post-intervention (+/- 2 weeks after the intervention)

Overall trial start date

01/03/2018

Overall trial end date

01/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Grade 2 or grade 3 students of Dutch high schools
2. Lower General Secondary Education or higher

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

Target number of participants: 1000. Target number of clusters: 10, with 100 expected participants each.

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/05/2018

Recruitment end date

01/10/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije Universiteit Amsterdam
De Boelelaan 1105
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Vrije Universiteit Amsterdam

Sponsor details

De Boelelaan 1105
Amsterdam
1081 HV
Netherlands
+31 (0)205989898
m.m.r.inhulsen@vu.nl

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Hersenstichting

Alternative name(s)

Nederlandse Hersenstichting, Hersenstichting Nederland

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Results and Publications

Publication and dissemination plan

The researchers will publish at least two scientific articles on the results of this study. Furthermore, they will present their findings at (inter-)national conferences. Publication and dissemination activities are expected from winter 2019 onwards.

IPD sharing statement
The data sharing plans for the current study are currently unknown and will be made available at a later date.

Intention to publish date

01/01/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/11/2019: Trial's existence confirmed by ethics committee.