UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020005 |
|---|---|
| Receipt number | R000022248 |
| Scientific Title | Sleep and mental health among people attending special health check-ups |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2016/11/29 09:34:42 |
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Basic information
Public title
Sleep and mental health among people attending special health check-ups
Acronym
Sleep and mental health among people attending special health check-ups
Scientific Title
Sleep and mental health among people attending special health check-ups
Scientific Title:Acronym
Sleep and mental health among people attending special health check-ups
Region
| Japan |
Condition
Condition
ordinary people (people attending special health check-ups)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to explore the relationship among general health conditions including metabolic syndrome, sleep, workaholic and work engagement by utilizing special health check-ups.
Basic objectives2
Others
Basic objectives -Others
understand and analyze the current situation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSQI
Key secondary outcomes
K6, UWES, DUWAS
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a Japanese conversational ability to understand the scope of the present study and to provide written consent for study participation
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Yamanouchi |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL
042-341-2711
yamanouchi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Nishi |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
d-nishi@umin.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Tokyo Yamate Medical Center
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京山手メディカルセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/joh/advpub/0/advpub_16-0167-OA/_article
Number of participants that the trial has enrolled
Results
Dietary intake of fish, regular exercise, sufficient sleep, and abstinence from tobacco were significantly correlated with the total UWES-9 score, even after adjusting for age, sex, and depressive and anxiety symptoms. The results suggested a dose-response relationship between dietary fish intake and work engagement.These findings could be useful in motivating employees to make lifestyle improvements and convincing employers and managers that lifestyle is important not only for health but also for productivity.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study.
We will recruit participants who will attend at Tokyo Yamate Medical Center for special health check-ups during December 2015.
PSQI, K6, UWES short version and DUWAS will be measured.
Management information
Registered date
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
