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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000127
Receipt No. R000000187
Scientific Title The High-Risk and Population Strategy for Occupational Health Promotion (HIPOP-OHP) study
Date of disclosure of the study information 2005/09/12
Last modified on 2005/09/07

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Basic information
Public title The High-Risk and Population Strategy for Occupational Health Promotion (HIPOP-OHP) study
Acronym HIPOP-OHP study
Scientific Title The High-Risk and Population Strategy for Occupational Health Promotion (HIPOP-OHP) study
Scientific Title:Acronym HIPOP-OHP study
Region
Japan

Condition
Condition hypertension, dyslipidemia, glucose intolerance and smoking
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve cardiovascular risk factors for young and middle-aged workers by non-pharmacological population strategy and high-risk strategy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes hypertension, dyslipidemia, glucose intolerance and smoking
Key secondary outcomes lifestyle factors such as diet, exercise and drinking, knowledge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The intervention group consisted of Companies A-F with Company A, the headquarters office of a life insurance company in Tokyo, Company D, factory of chemical products and other companies, electrical appliance manufacturers. Company C was located in the Kanto area in east Japan while the other 4 companies were located in west Japan either in the Kinki (Companies D, E and F) or Hokuriku areas (Company B).
Interventions/Control_2 The control group consisted of Companies H-L. Company H was a chemical company factory in Tokyo, while 4 companies were factories of electrical appliance manufacturers, with Companies G and K being located in the Kanto area and Companies I and J in the Hokuriku area. 3,500 wokers aged 18 to 65.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria healthy workers aged 18 to 65
Key exclusion criteria coronary heart disease, stroke
Target sample size 7000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Ueshima
Organization Shiga University of Medical Science
Division name Department of health science
Zip code
Address Seta-tsukinowa-cho, Otsu, Shiga
TEL 077-548-2191
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Okamura
Organization Shiga University of Medical Science
Division name Department of health science
Zip code
Address Seta-tsukinowa-cho, Otsu, Shiga
TEL 077-548-2191
Homepage URL http://hs-web.shiga-med.ac.jp
Email tokamura@belle.shiga-med.ac.jp

Sponsor
Institute HIPOP-OHP Study Research group
Institute
Department

Funding Source
Organization Research grants from the Ministry of Health, Labour and Welfare, Japan (H10-12:No.063,H13: No.010,H14-16: No.010).
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 12 Day

Related information
URL releasing protocol http://hs-web.shiga-med.ac.jp
Publication of results Published

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
1998 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
1999 Year 01 Month 01 Day
Last follow-up date
2005 Year 01 Month 01 Day
Date of closure to data entry
2005 Year 03 Month 01 Day
Date trial data considered complete
2005 Year 03 Month 01 Day
Date analysis concluded
2006 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 07 Day
Last modified on
2005 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000187

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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