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)
Hersenstichting Nederland, Nederlandse Hersenstichting
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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