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

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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 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

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

Value
https://center6.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