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

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 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


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

Value
https://center6.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