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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017740
Receipt No. 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

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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
Email 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
Email starlight-shower@nifty.com

Sponsor
Institute Department of Public Health, Dokkyo Medical University, School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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