UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039940 |
|---|---|
| Receipt number | R000045542 |
| Scientific Title | Effects of health management and free on-site health education intervention by industry for small and medium-sized enterprises |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2020/03/25 17:36:19 |
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Basic information
Public title
Effects of health management and free on-site health education intervention by industry for small and medium-sized enterprises
Acronym
Effects of health management and free on-site health education intervention for workers' and managers'
Scientific Title
Effects of health management and free on-site health education intervention by industry for small and medium-sized enterprises
Scientific Title:Acronym
Effects of health management and free on-site health education intervention for workers' and managers'
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the presence or absence of improvement in health checkup data, lifestyle, health, and health literacy by health management and free on-site health education for small and medium-sized enterprises
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the presence or absence of improvement in health checkup data, lifestyle, health, and health literacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education
Interventions/Control_2
Not implemented
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
1) Persons aged from 18 to 74 years old.
2) Persons who consented to participate in the study.
3) SME employers and employees
Key exclusion criteria
On sick leave
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fujimura |
Organization
University of Toyama
Division name
Organization for Promotion of Regional Collaboration, Community Medicine & Health Support Division
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama Pref.
TEL
076-434-7139
yfujimu@ctg.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Fujimura |
Organization
University of Toyama
Division name
Organization for Promotion of Regional Collaboration, Community Medicine & Health Support Division
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama Pref.
TEL
076-434-7139
Homepage URL
yfujimu@ctg.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
1) Grants-in-Aid for Scientific Researcch
2) University of Toyama
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2630 Sugitani, Toyama-shi, Toyama Pref.
Tel
076-434-7139
yfujimu@ctg.u-toyama.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
| 2020 | Year | 03 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045542
