UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of workplace-supporting exercise guidance on health improvement of workers with metabolic syndrome
Title of the study (Brief title)	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	masanori munakata
Organization	Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name	Preventive medicine section
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	masanori munakata
Organization	Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name	Preventive medicine section
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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