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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032556
Receipt No. R000037133
Scientific Title Effectiveness of Alcohol Screening and Brief Intervention (SBI) on the working generation in a rural island of Kagoshima
Date of disclosure of the study information 2018/05/11
Last modified on 2019/06/19

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Basic information
Public title Effectiveness of Alcohol Screening and Brief Intervention (SBI) on the working generation in a rural island of Kagoshima
Acronym Effectiveness of Alcohol SBI in a rural island
Scientific Title Effectiveness of Alcohol Screening and Brief Intervention (SBI) on the working generation in a rural island of Kagoshima
Scientific Title:Acronym Effectiveness of Alcohol SBI in a rural island
Region
Japan

Condition
Condition Excessive alcohol drinkers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To examine the effectiveness of Alcohol SBI on municipal workers and the general population in Yoron Town.
2. To identify factors associating with the successful reduction of alcohol intake of participants of SBI.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Japanese version of the Alcohol Use Disorders Identification Test (AUDIT).
Difference in the average score between pre- (the baseline) and post- (two months after, three months after, and five months after) the first session of SBI.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 Lecture session (1 session): disseminate basic knowledge of alcohol on human health, current alcohol intake status of local residents, and process of SBI
Brief Intervention (2 sessions): consists of group-working and drinking diary sessions. The first session is about 30 minutes long, and the second is 10 minutes.
Interventions/Control_2 Waiting group. After completing the SBI on the first intervention group, the same SBI will be implemented for the second group.
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
18 years-old <=
Age-upper limit
64 years-old >=
Gender Male and Female
Key inclusion criteria Employees of Yoron municipal government with his/her AUDIT score 8 and over,. on AUDIT,want to participate in Brief Intervention program, and understand the purpose of the research
Key exclusion criteria Person who has been diagnosed as alcohol dependent or has experiment of treatment for over drinking.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Miki
Middle name
Last name Akiyama
Organization Keio University
Division name Graduate School of Health Management
Zip code 2520883
Address 4411 Endo, Fujisawa, Kanagawa
TEL 0466-49-6265
Email miki@sfc.keio.ac.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Sakurai
Organization Keio University
Division name Graduate School of Health Management
Zip code 2520083
Address 4411 Endo, Fujisawa, Kanagawa
TEL 0466-49-6265
Homepage URL
Email h17120js@sfc.keio.ac.jp

Sponsor
Institute Graduate School of Health Management, Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Graduate School of Health Management, Keio University
Address 4411 Endo, Fujisawa, Kanagawa 252-0883
Tel 0466-49-6265
Email gshm-rinri@adst.keio.ac.jp

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
2018 Year 05 Month 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
2018 Year 04 Month 24 Day
Anticipated trial start date
2018 Year 05 Month 24 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 11 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037133

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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