UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044798
Receipt number R000051145
Scientific Title Association between job stress, lifestyle, work injuries, and depression
Date of disclosure of the study information 2021/07/10
Last modified on 2021/07/08 08:35:31

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Basic information

Public title

Association between job stress, lifestyle, work injuries, and depression

Acronym

Association between job stress, lifestyle, work injuries, and depression

Scientific Title

Association between job stress, lifestyle, work injuries, and depression

Scientific Title:Acronym

Association between job stress, lifestyle, work injuries, and depression

Region

Japan


Condition

Condition

Job stress

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate relationships between job stress, psychological stress, lifestyle, and work-related injuries and illness among Japanese employees.

Basic objectives2

Others

Basic objectives -Others

To improve employees' health

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Health promotion for employees

Key secondary outcomes

Job-related factors (job stress, work-related injuries and illness), sociodemographic characteristics, illness, and lifestyle


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Employees
2) Those who agreed to participate

Key exclusion criteria

Those who withdrew consent

Target sample size

120000


Research contact person

Name of lead principal investigator

1st name Akinori
Middle name
Last name Nakata

Organization

International University of Health and Welfare

Division name

Graduate School of Medicine

Zip code

107-8402

Address

4-1-26 Akasaka, Minato-ku, Tokyo

TEL

03-5574-3964

Email

nakataa-tky@umin.ac.jp


Public contact

Name of contact person

1st name Akinori
Middle name
Last name Nakata

Organization

International University of Health and Welfare

Division name

Graduate School of Medicine

Zip code

107-8402

Address

4-1-26 Akasaka, Minato-ku, Tokyo

TEL

03-5574-3964

Homepage URL


Email

nakataa-tky@umin.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

International University of Health and Welfare

Address

4-1-26 Akasaka, Minato-ku, Tokyo

Tel

03-5574-3900

Email

rinri-tky@iuhw.ac.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 07 Month 10 Day


Related information

URL releasing protocol

https://www.dropbox.com/s/9oo47q5otfx52lq/%E3%80%90%E6%9C%80%E7%B5%82%E7%89%88%E3%80%9119-Ig-98%E4%B

Publication of results

Partially published


Result

URL related to results and publications

https://drive.google.com/file/d/1G-zVOXqNmgMnHJeFAltLlEbwfRd2TMSu/view?usp=sharing

Number of participants that the trial has enrolled

120978

Results

Higher levels of social jetlag corresponded to significantly greater odds of suicidal ideation.

Results date posted

2021 Year 07 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Employees working in 227 companies and organizations in Japan

Participant flow

Those who agreed to respond questionnaire

Adverse events

None

Outcome measures

job stress, psychological stress, lifestyle, and work-related injuries and illness

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2004 Year 01 Month 05 Day

Date of IRB

2019 Year 09 Month 26 Day

Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2012 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This anonymous data was obtained from a data collecting company. The survey was targeted Japanese employees working in various industries and occupations between 2007 to 2012.


Management information

Registered date

2021 Year 07 Month 08 Day

Last modified on

2021 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051145