UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000163 |
|---|---|
| Receipt number | 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 10:18:17 |
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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
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
hueshima@belle.shiga-med.ac.j-p
Sponsor or person
Institute
HISLIM study research group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
