UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050743 |
|---|---|
| Receipt number | R000057764 |
| Scientific Title | Cross-sectional study to Improve the well-being of workers: a pilot study in Roppongi, Toranomon and Azabudai areas |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/04/01 23:49:46 |
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Basic information
Public title
Cross-sectional study to Improve the well-being of workers: a pilot study in Roppongi, Toranomon and Azabudai areas
Acronym
Cross-sectional study to Improve the well-being of workers: a pilot study in Roppongi, Toranomon and Azabudai areas
Scientific Title
Cross-sectional study to Improve the well-being of workers: a pilot study in Roppongi, Toranomon and Azabudai areas
Scientific Title:Acronym
Cross-sectional study to Improve the well-being of workers: a pilot study in Roppongi, Toranomon and Azabudai areas
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasebility for a cohort study of office workers to examine the association between health check data, work styles, etc. and well-being.
Basic objectives2
Others
Basic objectives -Others
To evaluate the sample size for a cohort study of office workers to examine the association between health check data, work styles, etc. and well-being.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Well-being indicators: Satisfaction With Life Scale, Flourishing Scale, Scale of Positive and Negative Experience
Key secondary outcomes
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. Belonging to or working for a organization which agreed to collaborate on this research,
2. 18 years of age or older
3. Understanding the content of this research and agreeing to join it with prior written consent.
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio University
Division name
School of Medicine, Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, Minato-ku, Tokyo
TEL
+81-3-5786-0006
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Kinoshita |
Organization
Keio University
Division name
School of Medicine, Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, Minato-ku, Tokyo
TEL
+81-3-5786-0006
Homepage URL
shotaro.kinoshita@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Mori Building Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cross-sectional study
Management information
Registered date
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057764
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
