UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017740 |
|---|---|
| Receipt number | R000016818 |
| Scientific Title | Observational study and intervention study for alcohol related problems in Japanese rural populations. |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2017/09/13 13:29:05 |
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Basic information
Public title
Observational study and intervention study for alcohol related problems in Japanese rural populations.
Acronym
Observational study and intervention study for alcohol related problems in Japanese rural populations.
Scientific Title
Observational study and intervention study for alcohol related problems in Japanese rural populations.
Scientific Title:Acronym
Observational study and intervention study for alcohol related problems in Japanese rural populations.
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effecacy of intervention for alcohol intake in communities. We will cooperate with local governments. We will use AUDIT and brief intervention method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, waist circumference, score of AUDIT, blood pressure levels and blood tests (serum fatty acids, blood glucose, HbA1c and hepatic enzymes)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
(Intervention group)Do brief intervention for alcohol intake in addition to ordinary health education to control metabolic syndrome.
Interventions/Control_2
(Control group)Do ordinary health education to control metabolic syndrome.
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who met all criterias below.
1. Diagnosed with metabolic syndrome by health check-up
2. Point out excess of low-risk alcohol intake by AUDIT
3. Agreed with the protocol of this study.
Key exclusion criteria
Subjects who did not meet criterias.
1. Diagnosed with metabolic syndrome by health check-up
2. Point out excess of low-risk alcohol intake by AUDIT
3. Agreed with the protocol of this study.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsumasa Umesawa |
Organization
Dokkyo Medical University, School of Medicine
Division name
Department of Public Health
Zip code
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi, Japan
TEL
0282-87-2133
starlight-shower@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsumasa Umesawa |
Organization
Dokkyo Medical University, School of Medicine
Division name
Department of Public Health
Zip code
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi, Japan
TEL
0282-87-2133
Homepage URL
starlight-shower@nifty.com
Sponsor or person
Institute
Department of Public Health, Dokkyo Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://mhlw-grants.niph.go.jp/index.html
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
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research reports are released at the MHLW GRANTS SYSTEM.
Management information
Registered date
| 2015 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
