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
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
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
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
