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临床试验/NCT04878380
NCT04878380已完成不适用

Evaluation of Goal-Based Interventions to Promote and Sustain Healthy Sleep Habits

National University of Singapore1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
225
试验地点
1
主要终点
Change in bedtimes measured by wearable device

研究概览

简要总结

The hiSG Sleep Health Study seeks to investigate the efficacy of education + goal-based programmes for the promotion of healthy sleep habits and to evaluate its impact on daytime sleepiness and mental health.

详细描述

This study is a sub-study under the existing Health Insights Singapore study (hiSG). The hiSG study is a longitudinal cohort study among working adults (aged 21-42y), monitoring health parameters through a Fitbit tracker and mobile phone-based questionnaires.

The hiSG Sleep Health Study (hiSG SHS) sub-study, will evaluate the efficacy of two goal-based interventions for improving sleep. Participants will be recruited from the existing hiSG subject pool (target N=300), and should have a habitual sleep duration below the recommended 7h (as determined from the currently available hiSG data). Following informed consent, participants will be randomized by the study team into two groups, a) Goal-Setting and b) Tracking, based on a 2:1 ratio, i.e. in the event 300 participants are enrolled, 200 will be allocated to Goal-Setting and 100 to Tracking.

The study is 22 weeks long and will proceed in 3 main phases, namely, 1) Baseline (Week 1-2) 2) Intervention (Week 3-12), and 3) Follow-up (Week 13-22).

Throughout the study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week.

Daily questionnaires probing daytime sleepiness, mood, and stress levels as well as once-per-study phase sleep health, sleep hygiene, work-related stress and mental wellbeing questionnaires will be pushed to participants during the baseline (Week 1-2), intervention (Week 11-12) and follow-up periods (Week 21-22) via the hiSG mobile application. Participants will also be reimbursed for completion of these questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 42 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Existing participants in the hiSG study
  • Aged 21-42y
  • Sleep <7h habitually on weekdays

排除标准

  • Shift workers
  • Those required to work in different time zones
  • Currently Pregnant
  • Nursing mothers

结局指标

主要结局

Change in bedtimes measured by wearable device

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit earlier bedtimes across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in bedtime regularity (standard deviation) measured by wearable device

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit more consistent bedtimes across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in social jetlag (midpoint of sleep on weekends - weekdays) measured by wearable device

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit reduced social jetlag measures across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in scores on the Work-Related Perseverative Thought and Work Home Interference questionnaires

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit reduced work stress levels across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in sleep duration measured by wearable device (mins)

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit longer sleep duration across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in scores on the Sleep Health Index questionnaire

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit improved sleep health across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in scores on the Sleep Hygiene Scale questionnaire

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit better sleep hygiene across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in sleep duration regularity (standard deviation) measured by wearable device (mins)

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit more consistent sleep durations across both Intervention and Follow-Up phases, compared to the Tracking group.

Change in scores on the Oldenberg Burnout Inventory questionnaire

时间窗: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)

We hypothesize that the Goal-Setting group will exhibit reduced burnout across both Intervention and Follow-Up phases, compared to the Tracking group.

次要结局

  • Bi-directional relationships between amount of nocturnal sleep obtained and daytime sleepiness levels.(Day-by-day associations (Week 1-2, Week 11-12, Week 21-22))
  • Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood and stress levels.(Day-by-day associations (Week 1-2, Week 11-12, Week 21-22))
  • Bi-directional relationships between amount of nocturnal sleep obtained and daytime motivational levels.(Day-by-day associations (Week 1-2, Week 11-12, Week 21-22))
  • Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood levels.(Day-by-day associations (Week 1-2, Week 11-12, Week 21-22))
  • Associations between Oldenberg Burnout Inventory, Work-Related Perseverative Thought and Work Home Interference with poorer Sleep Health Index scores.(Average scores (Week 1-2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael W.L. Chee

Professor

National University of Singapore

研究点 (1)

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