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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | The high-risk strategy by lifestyle
modification (HISLIM) study |
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Acronym | HISLIM study | |
Scientific Title | The high-risk strategy by lifestyle
modification (HISLIM) study |
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Scientific Title:Acronym | HISLIM study | |
Region |
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Condition | |||
Condition | hypercholesterolemia,hypertension,smoking | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | under cholesterol lowering drug
under anti-hypertensive drug past history of stroke past history of acute myocardial infaction |
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Target sample size | 1800 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |