UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044143 |
|---|---|
| Receipt number | R000050400 |
| Scientific Title | The effect of health promotion activity in industry using LOCABO to Japanese workers. |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/05/08 10:14:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of health promotion activity in industry using LOCABO to Japanese workers.
Acronym
The effect of health promotion activity in industry using LOCABO to Japanese workers.
Scientific Title
The effect of health promotion activity in industry using LOCABO to Japanese workers.
Scientific Title:Acronym
The effect of health promotion activity in industry using LOCABO to Japanese workers.
Region
| Japan |
Condition
Condition
Diabates
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of LOCABO challenge to Metabolic syndrome traits in Japanese workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood sugar
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
Inclusion: Workers who satisfied with Metabolic syndrome criteria or who satisfied with the Specific Health Guidance criteria in Lawson Inc. or Hinomaru Kotsu Co.Ltd.
Key exclusion criteria
Workers who do not give consent in opt-out method.
Target sample size
113
Research contact person
Name of lead principal investigator
| 1st name | Yamada |
| Middle name | |
| Last name | Satoru |
Organization
TBD
Division name
Director
Zip code
108-0072
Address
4-9-13-308 ,Shirogane,Minato-ku
TEL
00-0000-0000
xx@xx
Public contact
Name of contact person
| 1st name | Yamada |
| Middle name | |
| Last name | Satoru |
Organization
TBD
Division name
Director
Zip code
108-0072
Address
4-9-13-308 ,Shirogane,Minato-ku
TEL
00-0000-0000
Homepage URL
xx@xx
Sponsor or person
Institute
TBD
Institute
Department
Personal name
Funding Source
Organization
TBD
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
Kitasato Institute Hospital
Address
5-9-1 Shirogane,Minato-ku
Tel
00-0000-0000
xx@xx
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 | 06 | 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
113
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
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
null
Management information
Registered date
| 2021 | Year | 05 | Month | 08 | Day |
Last modified on
| 2021 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050400
