UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000127 |
|---|---|
| Receipt number | 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 18:05:35 |
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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
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
tokamura@belle.shiga-med.ac.jp
Sponsor or person
Institute
HIPOP-OHP Study Research group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000187
