AzTrials
AzTrials

SleepNCT04669236

Promoting Healthy Sleep in Adolescents: a Participatory Health Research Approach

A study testing Intervention to promote healthy sleep behavior in people with Sleep, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Adolescent sleep deprivation is becoming increasingly recognized internationally as a significant health concern. This project will be the first to use a unique approach of actively involving adolescents as real life experts in the development of interventions to improve sleep behaviour (using a participatory health… Read more about this study

Who is it for?
Ages 13 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Intervention to promote healthy sleep behavior
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,044 participants
Where
1 siteBelgium
Study dates
25 Jun 2017to 15 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Between 13 and 16 years old
  • Dutch speaking
  • Education: ASO (General Secondary Education), TSO (Technical Secondary Education) or BSO (Vocational Secondary Education)

Who cannot join

  • Having a sleeping disorder
  • BUSO (Special Secondary Education)

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Ghent University-Public Health Department

    Ghent, East-Flanders, 9000

Other trials in Belgium

About this study

Adolescent sleep deprivation is becoming increasingly recognized internationally as a significant health concern. This project will be the first to use a unique approach of actively involving adolescents as real life experts in the development of interventions to improve sleep behaviour (using a participatory health research methodology) and to evaluate the effectiveness of these interventions (using a randomised controlled trial).

Read the detailed description

The project will develop an intervention to promote healthy sleep behaviour in adolescents. The intervention will be based on a participatory health research approach to promote healthy sleep behaviour in adolescents. Because healthy sleep behaviour is associated with a healthy lifestyle overall, the intervention will additionally focus on healthy eating patterns, sedentary behaviour and physical activity. In order to become the most effective intervention, adolescents will participate during every step of the intervention development.

Three school in Flanders are contributing to this project on a voluntary basis. All adolescents age 13 to 15 of the intervention schools were invited to participate in the study by an informative session at the school, where they were informed about the importance of their involvement in the study and the aim of the intervention. The adolescents who gave their consent, were invited to participate in a workshop were skills needed for participatory research were trained. Afterwards, an action group (6 - 8 pupils) was conducted at each school. Brainstorm sessions about effective strategies to change sleeping behavior in this population. Strategies, perceived as effective by the target population, will be summarized in an overview. Also feedback of adolescent, who are not part of the action group, will be asked. After feedback, the intervention will be developed by the intervention schools. Thereby, three different intervention strategies will be implemented and tested (one intervention at each school) to meet the individuals needs of each school. Right now, the action groups are busy conducting the intervention materials during a weekly 1-hour session. This session is accompanied by two researchers to provoke brainstorm sessions and creativity. The researchers facilitate the process, stimulates creativity, organize and keep track of the feasibility of ideas. After the development of intervention materials, the intervention will be implemented in the school by the adolescents themselves, in collaboration with teachers and the two researchers.

Overall, can be stated that a group oriented approach will be used during the whole intervention. For example, plenary speakers will give information about sleep hygiene, physical activity breaks will be introduced, sleep behaviour will be discussed in class, active transport will be stimulated, a campaign on social media will be started, and informative flyers/posters about sleep, screen time, physical activity and nutrition will be spread in the close neighborhood, a competition between class groups will be started (based on objective data collected using activity trackers).

The intervention will be analysed using a clustered randomized controlled trial, including three intervention schools and six control schools. These schools were recruited in Flanders, the Northern part of Belgium, via convenience sampling. The head of each school was contacted via telephone. When the head of the school gave consent, all adolescents age 13 - 15 and their parents were invited to participate in this study. All adolescents who gave their consent, were pre-tested (between November 2017 and January 2018). The pre-test included a questionnaire investigating determinants of sleep and a wearable activity tracker to objectively measure the sleep duration. The questionnaires were developed based on the 'Munich ChronoType Questionnaire', 'The School Sleep Habits Survey', 'Sleep Knowledge Questionnaire', 'Sleep Hygiene Index' and 'Paediatric Daytime Sleepiness Scale'. Focus groups were organized to determine relevant determinants. The understandability of the questionnaire was tested with the 'Thinking aloud protocol' and validation testing was performed. After implementing the intervention at the intervention schools, an effect-evaluation will be conducted based on a pre-,post and follow-up testing and a process evaluation will be performed.

Conditions
Sleep
Being tested
Intervention to promote healthy sleep behavior
Keywords
Sleep behaviour, Adolescents, Participatory health research, Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention to promote healthy sleep behaviorBehavioural

    An action group (6 - 8 pupils) was conducted at each school. Brainstorm sessions about effective strategies to change sleeping behavior in this population were held. Strategies, perceived as effective by the target population, will be summarized in an overview. Also feedback of adolescent, who are not part of the action group, will be asked. After feedback, the intervention will be developed by the intervention schools. Thereby, three different intervention strategies will be implemented and tested (one intervention at each school) to meet the individuals needs of each school. The action groups will develop the intervention materials during sessions this year. Afterwards, they will implement the intervention themselves in collaboration with teachers of the school and the researchers.

Study groups in NCT04669236
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention promoting healthy sleep behaviour in adolescents based on a participatory health research approach. Based on participatory session, the pupils of the action group will develop the intervention. They will participate in every step of the development to maximize their input.
Receives: Behavioral: Intervention to promote healthy sleep behavior
Control groupNo interventionParticipants in the control group will receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep duration as assesed by the Munich Chronotype Questionnaire for children

    to ask about students' sleep habits over the past 2 weeks, differentiating between sleep on school nights (Sunday to Thursday) and weekend nights (Friday and Saturday). Students will be asked to report their typical go to bed time, lights-out time, sleep onset latency, total sleep time, wake-up time, and out of bed time. This questionnaire showed good validity against objective sleep measures (i.e., actigraphy).

    Measured: 2 years

  2. Sleep quality as assesed by the short Adolescent Sleep Wake Scale

    10 questions on sleep quality and sleep habbits, topics are: going to bed, during the night and waking up

    Measured: 2 years

Secondary outcomes (4)
  1. Sleep knowledge

    Sleep knowledge will be measured using a Sleep Knowledge Questionnaire consisting of 15 questions with a true/false response format. This questionnaire has shown to be sensitive to changes and to offer a degree of discriminant validity; however, the test-retest reliability is unknown and will be tested at the start of this project.

    Measured: 2 years

  2. Sleep hygiene

    Sleep hygiene will be assessed using the Sleep Hygiene Index including 13 items scored on 5-point Likert-type scale with answers (1) ranging from always to never (5). A sum score can be made of all questions to obtain a total score. The higher the total score, the better the sleep hygiene. The internal consistency of this scale is found to be acceptable and test-retest reliability is good.

    Measured: 2 years

  3. Daytime sleepiness

    Daytime sleepiness will be measured by the validated Paediatric Daytime Sleepiness Scale. This scale contains eight items about aspects of daytime sleepiness experienced by students (e.g., How often do you get sleepy or drowsy while doing your homework?). Answers range from never (0) to always (4) on 5-point Likert-type scale. For total score, a sum score should be made of all answers. Abnormal values: 6th and 7th grade >26, 8th grade >30.

    Measured: 2 years

  4. Socio-demographic and theory-based psychosocial correlates

    Socio-demographic and theory-based psychosocial correlates of sleep behaviour will be measured by a self-developed questionnaire based on existing questionnaires assessing correlates of health behaviour used in previous studies of our research group. The questionnaire will be pilot-tested on comprehension and psychometrics at the start of this project.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start25 Jun 2017
  3. Primary completion31 Dec 2020
  4. Study completion15 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pre, post and follow-up testing with 3 intervention and 6 control schools
Masking
None (open label)
Enrolment
2,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04669236
Sponsor's protocol ID
B670201630466
Status last verified
Feb 2023
First submitted
12 Nov 2018
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vandendriessche A, Verloigne M, Dhondt K, Altenburg TM, Demeester B, Deforche B. Your project or our project? Evaluating the participatory development of an adolescent healthy sleep intervention. BMC Public Health. 2025 Nov 25;26(1):28. doi: 10.1186/s12889-025-25667-9.

    PubMed 41291635
  • Vandendriessche A, Deforche B, Dhondt K, Verloigne M, Van Cauwenberg J. Effect evaluation of a participatory developed school-based healthy sleep intervention for adolescents. Health Psychol. 2025 Apr;44(4):380-390. doi: 10.1037/hea0001443. Epub 2025 Jan 27.

    PubMed 39869691

Questions about this trial

What is this clinical trial studying?

A study testing Intervention to promote healthy sleep behavior in people with Sleep, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep duration as assesed by the Munich Chronotype Questionnaire for children (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669236, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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