UMIN-CTR Clinical Trial

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
Institute	International University of Health and Welfare
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051145