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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000294
Receipt No. 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

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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
Email

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
Email ikeda@tmresearch.co.jp

Sponsor
Institute The Tokio Marine Research Institute
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000372

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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