UMIN-CTR Clinical Trial

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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