UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055349 |
|---|---|
| Receipt number | R000063259 |
| Scientific Title | Building a database that contributes to the mental and physical health and well-being of working people. |
| Date of disclosure of the study information | 2024/08/27 |
| Last modified on | 2024/08/28 10:58:38 |
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Basic information
Public title
Research aiming to improve the mental and physical health and well-being of working people.
Acronym
Research aiming to improve the mental and physical health and well-being of working people.
Scientific Title
Building a database that contributes to the mental and physical health and well-being of working people.
Scientific Title:Acronym
Building a database that contributes to the mental and physical health and well-being of working people.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will collect various types of data from office workers in urban areas. Specifically, we will gather regular health check-up results and ePRO (electronic Patient-Reported Outcomes) using web questionnaires (Layer I). Additionally, we will collect more detailed data through wearable devices and other means (Layer II: optional participation) to build a database.
Basic objectives2
Others
Basic objectives -Others
Using this database, we aim to identify psychological and physical health issues among urban office workers and examine how these issues are interrelated. We will also investigate how psychological and physical health (well-being) is associated with various lifestyle and environmental factors, particularly work styles, and to what extent improvements in psychological and physical health can be achieved through environmental changes and behavioral modifications.
In the future, by constructing this database and analyzing the accumulated data, we aim to contribute to the creation of social services that promote mental and physical health and enhance well-being.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SWLS, FS, SPANE
Key secondary outcomes
Survey Items in the Questionnaire:
Background:
Age, gender, family composition, household duties, work area, years of service, experience with job changes, job type/position, employment status, commuting/work attendance status, working hours, income, residential history, daily time usage.
Medical Background:
Current and past medical history, medication use, menstruation, pregnancy, childbirth.
Lifestyle Habits:
Frequency and content of meals, frequency and type of exercise, frequency and content of use of stimulants, sleep.
Work Style and Rest Information:
Job characteristics/tasks, communication at work, IT literacy, absenteeism, presenteeism, work environment, Japanese version of the UWES (Utrecht Work Engagement Scale), Japanese version of the Recovery Experience Questionnaire.
Depression and Anxiety:
PHQ-9, STAI, availability of someone to consult.
New Life Events:
Personal life events, work-related events, leave of absence/return to work, illness or injury.
Health Check-up Results:
Mandatory Health Check-up Items: The following 11 items as stipulated by Article 43 of the Ordinance on Industrial Safety and Health.
1. Investigation of medical history and occupational history.
2. Examination of subjective and objective symptoms.
3. Measurement of height, weight, abdominal circumference, vision, and hearing.
4. Chest X-ray examination.
5. Blood pressure measurement.
6. Anemia test (red blood cell count, hemoglobin concentration).
7. Liver function tests (AST, ALT, gamma-GTP).
8. Blood lipid tests (triglycerides, HDL cholesterol, LDL cholesterol).
9. Blood glucose test (blood glucose level).
10. Urinalysis (urine sugar, urine protein).
11. Electrocardiogram.
Optional Health Check-up Items:
In addition to the mandatory items, any additional examination items deemed necessary by the research subjects or their employers.
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. Individuals who are affiliated with or employed by companies (research collaborating institutions) that have expressed cooperation with the research.
2. Adults aged 18 or older.
3. Individuals who understand the content of this study and have provided consent in writing (including electronic consent).
Key exclusion criteria
None
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio University School of Medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0041
Address
7th Floor, Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-5363-3219
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Kinoshita |
Organization
Keio University School of Medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0041
Address
7th Floor, Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-5363-3219
Homepage URL
contact@i2lab.info
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
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, IRB
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
keio@esct.bvits.com
Secondary IDs
Secondary IDs
YES
Study ID_1
20241005
Org. issuing International ID_1
Keio University School of Medicine, IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will target 10,000 office workers primarily working in urban areas. After obtaining the consent of the companies they are affiliated with, we will acquire electronic consent from the participants.
We will collect and database the Layer I data listed below using the following methods: [Layer I] Participants will receive a link to an electronic questionnaire via email or other means. Through this questionnaire, we will collect information on the participants' background, work style, rest habits, and labor productivity, in addition to various indicators related to well-being and psychological state, as well as information on occurrences of leave. Furthermore, we will obtain health check-up data for the participants and link it to the information gathered from the questionnaire.
Additionally, the Layer II data listed below will be collected only from those participants who have provided consent for this optional part. This data will be linked to the Layer I data and stored in the database.
[Layer II] In the future, in addition to the aforementioned Layer I data, we will collect detailed Layer II data (e.g., 24-hour ECG data, 24-hour blood pressure monitor data, simplified sleep EEG data, blood test data not included in regular health check-up items) from participants who have provided consent for this optional part. These data will be linked with the Layer I data.
Management information
Registered date
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063259
