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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000163
Receipt No. R000000235
Scientific Title The high-risk strategy by lifestyle modification (HISLIM) study
Date of disclosure of the study information 2005/10/01
Last modified on 2005/09/12

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Basic information
Public title The high-risk strategy by lifestyle
modification (HISLIM) study
Acronym HISLIM study
Scientific Title The high-risk strategy by lifestyle
modification (HISLIM) study
Scientific Title:Acronym HISLIM study
Region
Japan

Condition
Condition hypercholesterolemia,hypertension,smoking
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To exmaine the effect of health ecducation program to reduce the risk by selecting high risk participants havign more than 2 of hypercholesterolemia, hypertension and smoking
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes serum total cholesterol
blood pressure
prevalence of smoking
Key secondary outcomes physical activity
body weight
dietary habits

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Six month health education program to reduce serum cholesterol levels by life style modification
Interventions/Control_2 Six month health education program to reduce blood pressure by life style modification
Interventions/Control_3 Six month health education program to stop smoking.20
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
20 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1.Serum cholesterol levels with 230 mg/dl or more.
2.Smoking with 1 month or more
3.Systolic blodd pressre 140 mmHg or more or/and diastolic blood pressure 90 mmHg or more
Each center select participants with 2 of factors.
Key exclusion criteria under cholesterol lowering drug
under anti-hypertensive drug
past history of stroke
past history of acute myocardial infaction
Target sample size 1800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIrotsugu Ueshima
Organization Shiga University of Medical Sciences
Division name Health Sicience
Zip code
Address Setatsukinowacho, Ohtsu
TEL 077-548-2191
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Ueshima
Organization Shiga University of Medical Sciences
Division name Health Sicience
Zip code
Address Setatsukinowacho, Ohtsu
TEL 077-548-2191
Homepage URL
Email hueshima@belle.shiga-med.ac.j-p

Sponsor
Institute HISLIM study research group
Institute
Department

Funding Source
Organization Research Grant from MInistry of Health and Welfare.
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 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
significant reduction of prevaelce of smoking by support program.
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
1995 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
1995 Year 12 Month 01 Day
Last follow-up date
1998 Year 01 Month 01 Day
Date of closure to data entry
1998 Year 03 Month 01 Day
Date trial data considered complete
2000 Year 03 Month 01 Day
Date analysis concluded
2005 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2005 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000235

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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