Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04669236 |
| Other study ID # |
B670201630466 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 25, 2017 |
| Est. completion date |
January 15, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
University Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 research methodology) and to evaluate
the effectiveness of these interventions (using a randomised controlled trial).
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.
