UMIN-CTR Clinical Trial

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