Clinical trial NCT03620240: An Interactive School Sleep Education Program
Official title: An Interactive School Sleep Behavior Modification Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 205
Sex: MALE
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to improve sleep behavior in secondary school students, through the use of an educational program specifically designed for this purpose. Data will be collected on students' time use, sleep habits, daytime functioning and mood before and after the program to assess if the program is effective in improving students' sleep behavior and corresponding outcomes.

Detailed description: The present study aims to examine the effectiveness of a class-based interactive Sleep Education Program in improving sleep behavior of secondary school students. The Sleep Education Program is designed by sleep experts from our laboratory, and is aimed at educating students about the importance of sleep and good sleep habits, as well as addressing their attitudes towards sleep, in order to encourage behavior change. Participants will be randomly assigned to the Sleep Education Program or a Control Program. All participants will undergo four weekly class-based lessons, which use video presentations, in-class activities, discussions and take-home assignments to deliver the materials. Each lesson has set goals to achieve. Participants in the Sleep Education Program will learn about the importance of sleep, what factors may prevent them from getting enough sleep, how they can manage their time to create more opportunity for sleep, and how they can overcome obstacles to time management. Emphasis will be placed on how sleep affects each student personally, and how each person can benefit from improving sleep. Participants in the Control Program will undergo a similarly structured class-based program, during which they will learn about various general health-related topics. However, the Control Program is designed in such a way that it does not cover any topics related to sleep. Data will be collected from participants from both groups. The following variables are measured: sleep habits, sleep knowledge, daytime functioning, mood and app-tracked time use. Data on all measurements will be collected at three time points: pre-program, immediately post-program and during a 1-month follow-up. Results will be compared between the three time points, as well as between the two groups (Sleep Education Program and Control Program). By comparing results from the Sleep Education Program to the Control Program, we can evaluate the effect of educating students about sleep on improving sleep behavior.

Eligibility criteria: Inclusion Criteria:

* Secondary school students
* Currently in year 2

Exclusion Criteria:

* Secondary school students form years other than year 2

Primary outcomes:
measure: Change in actigraphically measured sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured for one week in each of the three phases.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
measure: Change in sleep dairy reported sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), recorded for one week in each of the three phases.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
measure: Change in the level of subjective mood between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured once daily with a Mood Rating Scale over the period of one week.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
measure: Change in the level of subjective sleepiness between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured once daily with the Karolinska Sleepiness Scale over the period of one week.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
measure: Change in sleep knowledge between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured with a sleep knowledge questionnaire.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
measure: Change in time use between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured daily with a time use diary over the period of one week.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
measure: Relationship between sleep and time use.
timeFrame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Medical School
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Michael WL Chee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Rijn E, Koh SYJ, Ng ASC, Vinogradova K, Chee NIYN, Lee SM, Lo JC, Gooley JJ, Chee MWL. Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial. Sleep Health. 2020 Apr;6(2):137-144. doi: 10.1016/j.sleh.2019.10.006. Epub 2019 Dec 4.