UMIN-CTR Clinical Trial

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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