UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Community Based Alcohol Brief Interventions for High-Risk Drinkers in a Rural Community, Western Kenya
Title of the study (Brief title)	Community-based alcohol brief intervention for high-risk drinkers in Kenya
Region	Africa

Condition
Condition	Healthy adults:high-risk drinkers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of community-based ABI delivered by Community health worker with or without motivational talk by former drinker in reducing AUDIT
Basic objectives2	Others
Basic objectives -Others	Effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Score of the Alcohol Use Disorders Identification Test
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	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	3 times brief counseling
Interventions/Control_2	3 times brief counseling plus 2 timess motivational talk
Interventions/Control_3	Provided general information related on alcohol take
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Male and female aged 18 to 65 2)Individuals with an AUDIT score of 8 to 19 3)Individuals with permanent residence in the study area and with no plan of moving out in the next 12 months 4)Individuals who are willing to participate in the study
Key exclusion criteria	1)Pregnant women 2)Individuals with history of alcohol related health problems or psychiatric disease 3)Individuals who are currently under treatment for alcohol related health problems or a psychiatric disease 4)Individuals participating or intending to participate in another alcohol related intervention
Target sample size	150

Research contact person
Name of lead principal investigator	RISA TAKAHASHI
Organization	Tenri Health Care University
Division name	Department of Nursing sciences
Address	80-1 Bessho-cho, Tenri, Nara
TEL	81-743-63-7811
Email	takahashi.r@tenriyorozu-u.ac.jp

Public contact
Name of contact person	RISA TAKAHASHI
Organization	Tenri Health Care University
Division name	Department of Nursing sciences
Address	80-1 Bessho-cho, Tenri, Nara
TEL	81-743-63-7811
Homepage URL
Email	takahashi.r@tenriyorozu-u.ac.jp

Sponsor
Institute	Tenri Health Care University
Institute
Department

Funding Source
Organization	MEXT JAPAN
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2017 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 07 Day
Last modified on	2017 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032188