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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000633
Receipt No. R000000767
Scientific Title Comprehensive Health Education Combining Hot Spa Bathing and Lifestyle Education in Blue-collar Employees: A Randomized Controlled Trial
Date of disclosure of the study information 2007/03/09
Last modified on 2008/11/14

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Basic information
Public title Comprehensive Health Education Combining Hot Spa Bathing and Lifestyle Education in Blue-collar Employees: A Randomized Controlled Trial
Acronym Effectiveness of Comprehensive Health Education
Scientific Title Comprehensive Health Education Combining Hot Spa Bathing and Lifestyle Education in Blue-collar Employees: A Randomized Controlled Trial
Scientific Title:Acronym Effectiveness of Comprehensive Health Education
Region
Japan

Condition
Condition Healthy blue-collar employees
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of comprehensive health education combining hot spa bathing and lifestyle education
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood profile (Serum Glucose,HDL-C,LDL-C,UA,HbA1c,Fructosamine,Lactic Acid,ChE,NK cytotoxicity)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 For 6 months, we give comprehensive health education combining hot spa bathing and lifestyle education.
Interventions/Control_2 For 6 months, we give comprehensive health education, not combining hot spa bathing.
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
33 years-old <=
Age-upper limit
59 years-old >=
Gender Male
Key inclusion criteria blue-collar employees
Key exclusion criteria having a disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinpei Okada
Organization Mimaki Social Welfare Corporation
Division name Physical Education and Medicine Reseach Center
Zip code
Address Nunoshita 6-1, Tomi-city, Nagano
TEL 0268-61-6148
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mimaki Social Welfare Corporation
Division name Physical Education and Medicine Reseach Center
Zip code
Address
TEL 0268-61-6148
Homepage URL
Email

Sponsor
Institute Physical Education and Medicine Reseach Center, Mimaki Social Welfare Corporation
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2007 Year 03 Month 09 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
2006 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 09 Day
Last modified on
2008 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000767

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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