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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention 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 group | No intervention | Participants 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.
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
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)
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
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
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
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.
- First posted16 Dec 2020
- Study start25 Jun 2017
- Primary completion31 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedicte Deforche, Study director, University Ghent
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 41291635Vandendriessche 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Sleep in Adolescents: a Participatory Health Research Approach
- ClinicalTrials.gov ID
- NCT04669236
- Acronym / sponsor ID
- B670201630466
- Conditions
- Sleep
- Keywords
- Sleep behaviour, Adolescents, Participatory health research, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,044 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 25 Jun 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre, post and follow-up testing with 3 intervention and 6 control schools
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention to promote healthy sleep behaviorIntervention 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. |
| Control group | No intervention | –Participants in the control group will receive no intervention. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 13 and 16 years old
- Dutch speaking
- Education: ASO (General Secondary Education), TSO (Technical Secondary Education) or BSO (Vocational Secondary Education)
Key exclusion criteria (2 listed)
- Having a sleeping disorder
- BUSO (Special Secondary Education)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention to promote healthy sleep behaviorAn 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. | Behavioural | Intervention group |
Primary outcome
Sleep duration as assesed by the Munich Chronotype Questionnaire for children
Time frame: 2 years
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).
Sleep quality as assesed by the short Adolescent Sleep Wake Scale
Time frame: 2 years
10 questions on sleep quality and sleep habbits, topics are: going to bed, during the night and waking up
4 secondary outcomes
Sleep knowledge
Time frame: 2 years
Sleep hygiene
Time frame: 2 years
Daytime sleepiness
Time frame: 2 years
Socio-demographic and theory-based psychosocial correlates
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 41291635Vandendriessche 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.
- Derived from this study: PubMed 39869691Vandendriessche 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedicte Deforche study director
University Ghent
1 site in 1 country: see every site and its status.
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.