UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021498
Receipt number R000024666
Scientific Title The effect of workplace-supporting exercise guidance on health improvement of workers with metabolic syndrome
Date of disclosure of the study information 2016/03/17
Last modified on 2016/09/27 10:16:07

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Basic information

Public title

The effect of workplace-supporting exercise guidance on health improvement of workers with metabolic syndrome

Acronym

J-STOP-METS WAVE 2 study

Scientific Title

The effect of workplace-supporting exercise guidance on health improvement of workers with metabolic syndrome

Scientific Title:Acronym

J-STOP-METS WAVE 2 study

Region

Japan


Condition

Condition

metabolic syndrome

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Establishment of effective lifestyle guidance for worker with metabolic syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Abdominal circumference, 6 months, 12 months after intervention

Key secondary outcomes

body composition, blood pressure, triglyceride, HDL-cholesterol, fasting blood glucose, pulse wave velocity, cathecholamines, hs-CRP, physical activity, self-efficacy measure


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Action A: Regular guidance + workplace-supporting exercise guidance (6 months) Regular guidance only(6 months)

Interventions/Control_2

Action B: Regular guidance only (6 months) Regular guidance + workplace-supporting exercise guidance(6 months)

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

28 years-old <=

Age-upper limit

66 years-old >=

Gender

Male and Female

Key inclusion criteria

Metabolic syndrome of workers

Key exclusion criteria

Severe joint disease
Stroke sequelae

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name masanori munakata

Organization

Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital

Division name

Preventive medicine section

Zip code


Address

3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan

TEL

+81-22-275-1111

Email

munakata@tohokuh.rofuku.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name masanori munakata

Organization

Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital

Division name

Preventive medicine section

Zip code


Address

3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan

TEL

+81-22-275-1111

Homepage URL


Email

munakata@tohokuh.rofuku.go.jp


Sponsor or person

Institute

Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Labor Health and Welfare Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東北労災病院(宮城県)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 17 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

Completed

Date of protocol fixation

2011 Year 12 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 16 Day

Last modified on

2016 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024666


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name