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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044143
Receipt No. 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

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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
Email 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
Email xx@xx

Sponsor
Institute TBD
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050400

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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