UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054082 |
|---|---|
| Receipt number | R000061743 |
| Scientific Title | The relationship between the disease prevention efforts of the health insurance society and the health status of small and medium-sized enterprise employee. (Retrospective cohort study) |
| Date of disclosure of the study information | 2024/04/08 |
| Last modified on | 2025/10/07 09:39:02 |
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Basic information
Public title
The relationship between the disease prevention efforts of the health insurance society and the health status of small and medium-sized enterprise employee.
Acronym
The relationship between the disease prevention efforts of the health insurance society and the health status of small and medium-sized enterprise employee.
Scientific Title
The relationship between the disease prevention efforts of the health insurance society and the health status of small and medium-sized enterprise employee. (Retrospective cohort study)
Scientific Title:Acronym
The relationship between the disease prevention efforts of the health insurance society and the health status of small and medium-sized enterprise employee.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the health status of small and medium-sized enterprise employees and the effects of the health insurance society implementing "collabo-health" and "health and productivity management".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, Risk of non-communicable diseases
Key secondary outcomes
Blood test values,
Risk factor of non-communicable diseases,
Desirable health behavior
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Employees of a company that belongs to the health insurance society.
Key exclusion criteria
Those without health checkups
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | SHIGEMATSU |
Organization
Chukyo University
Division name
School of Health and Sport Sciences
Zip code
470-0393
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi
TEL
0565-46-6158
shigematsu@sass.chukyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | NOMURA |
Organization
Chukyo University
Division name
School of Health and Sport Sciences
Zip code
470-0393
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi
TEL
0565-46-6158
Homepage URL
e.nomura@aiteturen-kenpo.or.jp
Sponsor or person
Institute
Chukyo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Chukyo University Toyota Campus Research Support Division
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi
Tel
0565-46-6150
kenkyurinri@ml.chukyo-u.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
| 2024 | Year | 04 | Month | 08 | 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
100000
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
| 2024 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using data held by health insurance society.
Management information
Registered date
| 2024 | Year | 04 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061743
