Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058532) titled 'Sleep log-based education and entrainment program for social jetlag in school-aged children and adolescents (SLEEP-Jet)' on July 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to examine whether a sleep log-based individualized sleep scheduling intervention can reduce social jetlag and improve sleep habits among school-aged children and adolescents. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group

Description: A 60-minute school-based sleep education program (including a quiz-based knowledge session and guidance on healthy sleep habits) will be delivered to students in grades 4 to 9 (elementary and junior high school). Sleep diaries and questionnaires will be administered before and after the intervention, and individualized feedback will be provided to set personalized bedtimes and wake-up times, with the aim of improving sleep habits.

Main components: Recording of sleep diaries for one week before and two weeks after the intervention Preparation and distribution (on the day of the intervention) of individualized feedback sheets, showing each student's average bedtime, wake-up time, and sleep duration (displayed as graphs and figures) based on their pre-intervention sleep diary data Based on the feedback sheet, students will be instructed to set a new target bedtime that is 15 minutes earlier than their previous average bedtime Students will be asked to practice achieving this target (e.g., increasing sleep duration by 105 minutes per week) for two weeks For students with late weekend wake-up times, guidance will be provided to wake up within one hour of their average weekday wake-up time (no later than 8:30 AM) A sleep-promoting behavior checklist will be used to help each student select feasible goals for improving their sleep habits

Period and frequency: Sleep education: Once (60-90 minutes, conducted at each school) Sleep diary recording: One week before and two weeks after the intervention Practice period for target behaviors: Two weeks

Evaluation (questionnaires and sleep diaries): Before and after the intervention

Notes: Primary and secondary outcomes will be assessed using sleep diaries and questionnaires before and after the intervention. Interventions/Control_2 - Control Group

Description: The control group will receive a single session of a standard, school-based sleep education program. This program, conducted during class hours, provides students with accurate sleep knowledge, promotes self-assessment of sleep habits and daily routines, and encourages goal setting and implementation of target behaviors. The main components are as follows:

Main components: Quiz-based sleep knowledge education using PowerPoint or similar materials (approximately 40 minutes) Explanations of the importance of sleep, strategies to improve sleep, and healthy lifestyle habits Administration of a 12-item sleep-promoting behavior checklist and self-assessment of current habits Each student selects one achievable target behavior from the checklist and is encouraged to practice it in daily life Students are instructed to practice their selected target behavior for approximately two weeks Evaluations using questionnaires are conducted at the same time points and frequency as in the intervention group

Period and frequency: Sleep education: Once (40 minutes, conducted at each school) Sleep diary recording: One week before and two weeks after the intervention Practice period for target behavior: Two weeks

Evaluation (questionnaires and sleep diaries): Before and after the intervention

Notes: Primary and secondary outcomes are evaluated before and after the intervention using sleep diaries and questionnaires The intervention follows a conventional program format

Eligibility: Age-lower limit - 9 years-old = Gender - Male and Female Key inclusion criteria - 1) Boys and girls enrolled in grades 4 through 9 (elementary grade 4 to junior high grade 3) 2) Children and students attending public elementary or junior high schools Key exclusion criteria - 1) Children and students enrolled in special needs schools 2) Schools or classes where consent for participation could not be obtained 3) Schools or classes deemed unsuitable for study implementation Target Size - 800

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 01 Month 05 Day Date of IRB - 2024 Year 04 Month 17 Day Anticipated trial start date - 2025 Year 02 Month 14 Day Last follow-up date - 2025 Year 09 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066933

Disclaimer: Curated by HT Syndication.