UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000607 |
|---|---|
| Receipt number | R000000732 |
| Scientific Title | Comprehensive Health Education Combining Hot Spa Bathing and Lifestyle Education in White-collar Employees: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2007/02/13 |
| Last modified on | 2009/03/31 15:29:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comprehensive Health Education Combining Hot Spa Bathing and Lifestyle Education in White-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 White-collar Employees: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Comprehensive Health Education
Region
| Japan |
Condition
Condition
Healthy white-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
In controll group, participants take only two lectures for the 6 months.
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
| 30 | years-old | <= |
Age-upper limit
| 57 | years-old | >= |
Gender
Male
Key inclusion criteria
white-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 | Hiroharu Kamioka |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environmental Science
Zip code
Address
Sakuragaoka 1-1-1, Setagaya-ku, Toukyo
TEL
03-5477-2587
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environmental Science
Zip code
Address
TEL
03-5477-2587
Homepage URL
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
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
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 | 02 | Month | 13 | 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
Rates of adherence to the tailor-made programs were 60.0% (SD 27.2) and 30.5%(SD 29.6) for the intervention and the 1-year observation period, respectively. Significant (p<0.05) interaction of the criteria was observed for the cluster of differentiation 4+ (CD4+) and the ratio of cluster of differentiation 4+ and 8+ (CD4/8), indicating participants' immunological function. We divided the intervention group into 2 subgroups on the basis of their attendance. Among these 3 groups, significant interaction of the criteria was observed for CD4+ and CD4/8. Additionally, the high attendance group showed high CD4+ and CD4/8 compared to the others.
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 | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 12 | Day |
Last modified on
| 2009 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000732
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
