UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062963 |
|---|---|
| Receipt number | R000064865 |
| Scientific Title | Measuring spill-over effects of Brief Intervention on remote islands |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 15:59:32 |
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Basic information
Public title
Exploring ways to support alcohol consumption reduction, for including non-intervention participants - Aiming to reduce health disparities on remote islands
Acronym
Measuring spill-over effects of alcohol consumption reduction support on remote islands
Scientific Title
Measuring spill-over effects of Brief Intervention on remote islands
Scientific Title:Acronym
Measuring spill-over effects of Brief Intervention on remote islands
Region
| Japan |
Condition
Condition
Excessive drinking
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the spill-over effects of BI to drinking peers in a region where drinking is common when socializing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spill-over effects of BI to drinking peers
Key secondary outcomes
effects of BI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Brief Intervention
Interventions/Control_2
no Brief Intervention
Interventions/Control_3
Drinking peers of a BI participant
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Employees at workplaces with many excessive drinkers
Key exclusion criteria
People diagnosed with alcohol dependence
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Sakurai |
Organization
Toho University
Division name
Fuclty of Nursing Science
Zip code
143-8540
Address
4-16-20 Omori-nishi Otaku,Tokyo
TEL
03-3762-4151
junko.sakurai@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sakurai |
Organization
Toho University
Division name
Fuculty of Nursing Science
Zip code
143-8540
Address
4-16-20 Omori-nishi Otaku, Tokyo
TEL
03-3762-4151
Homepage URL
junko.sakurai@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
other
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
National Hospital Organization Kurihama Medical and Addiction Center
Address
5-3-1Nobi Yokosuka-city Kanagawa
Tel
046-848-1550
junko.sakurai@med.toho-u.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
| 2026 | Year | 09 | Month | 17 | 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
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064865
