An Interactive School Sleep Education Program

NCT03620240 | Completed

• 1 other identifier: Sleep Education
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (7)

• 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.

  Bedtime, wake up time, time in bed, total sleep time, sleep efficiency, timing and duration of daytime naps

  3 times (pre-program, immediately post-program and at 1-month follow-up)

• 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.

  Bedtime, wake up time, total sleep time, sleep efficiency, number and duration of nighttime awakenings, number and duration of daytime naps

  3 times (pre-program, immediately post-program and at 1-month follow-up)

• 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.

  Score on the Mood Rating Scale. Range: 1 (extremely bad) to 9 (extremely good). Higher values represent a better outcome.

  3 times (pre-program, immediately post-program and at 1-month follow-up)

• 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.

  Score on the Karolinska Sleepiness Scale. Range: 1 (extremely alert) to 9 (extremely sleep, fighting sleep). Lower values represent a better outcome.

  3 times (pre-program, immediately post-program and at 1-month follow-up)

• 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.

  Score on the sleep knowledge questionnaire. Range: 0 (all incorrect answers) to 12 (all correct answers). Higher values represent a better outcome.

  3 times (pre-program, immediately post-program and at 1-month follow-up)

• 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.

  Amount of time spent on each activity

  3 times (pre-program, immediately post-program and at 1-month follow-up)

• Relationship between sleep and time use.

  Amount of time spent on each activity, measured with a time use diary, correlated with sleep variables, measured with actigraphy and a sleep diary.

  3 times (pre-program, immediately post-program and at 1-month follow-up)

Study Arms (2)

Sleep Education

EXPERIMENTAL

Half of the participants are randomly assigned to the Sleep Education group. These participants will undergo 4 weekly class-based lesson, during which they are educated about sleep.

Behavioral: Sleep Education

Control

NO INTERVENTION

Half of the participants are randomly assigned to the Control group. These participants undergo 4 weekly class-based lessons, during which they are educated about health-related topics, but not about sleep.

Interventions

Sleep Education BEHAVIORAL

Assessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students.

Sleep Education

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Secondary school students
• Currently in year 2

You may not qualify if:

• Secondary school students form years other than year 2

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

Related Publications (1)

• 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.

  PMID: 31812609 DERIVED

Study Officials

• Michael WL Chee, MBBS

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Professor

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 8, 2018
• Study Start: July 3, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)