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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021498
Receipt No. 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

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

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
URL(English) https://upload.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


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