UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000294 |
|---|---|
| Receipt number | R000000372 |
| Scientific Title | Effect of the life style improvement support program for the hypercholesterolemia, a randomized controlled trial |
| Date of disclosure of the study information | 2005/12/08 |
| Last modified on | 2007/05/02 16:35:13 |
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Basic information
Public title
Effect of the life style improvement support program for the hypercholesterolemia, a randomized controlled trial
Acronym
Life style support for the hypercholesterolemia (LSS-HC), a randomized controlled trial
Scientific Title
Effect of the life style improvement support program for the hypercholesterolemia, a randomized controlled trial
Scientific Title:Acronym
Life style support for the hypercholesterolemia (LSS-HC), a randomized controlled trial
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of life style improvement support program for hypercholesterolemia workers by way of evaluating reduction of total cholesterol value after the program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum total cholesterol
Key secondary outcomes
HbA1c, fasting blood glucose, LDL cholesterol, triglyceride, blood pressure, BMI, improvement of life style, ROI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group attend nine-month life style improvement program, in addition to ordinary health advice by corporate personnel department (if any)
Interventions/Control_2
Control group is given ordinary health advice by corporate personnel department (if any)
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Serum total cholesterol levels with 220 mg/dl or more
Key exclusion criteria
1.Patients of
(1)Ischemic heart desease
(2)Kidney desease of medium level (creatinine 2.0mg/dl or more, urinary protein 2+ or more)
(3)Diabetes
2.Persons with mental problems
3.Pregnant wemen
4.Persons who are not adequate for the research
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonari Ikeda |
Organization
The Tokio Marine Research Institute
Division name
Reseach Officer
Zip code
Address
2-1, Marunouchi 1-Chome, Chiyoda-ku, Tokyo
TEL
03-3285-0391
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonari Ikeda |
Organization
The Tokio Marine Research Institute
Division name
Reseach Officer
Zip code
Address
2-1, Marunouchi 1-Chome, Chiyoda-ku, Tokyo
TEL
03-3285-0391
Homepage URL
ikeda@tmresearch.co.jp
Sponsor or person
Institute
The Tokio Marine Research Institute
Institute
Department
Personal name
Funding Source
Organization
The Tokio Marine Research Institute
Organization
Division
Category of Funding Organization
Profit 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 | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2005 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 12 | Month | 08 | Day |
Last modified on
| 2007 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000372
