UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060685 |
|---|---|
| Receipt number | R000069408 |
| Scientific Title | A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption |
| Date of disclosure of the study information | 2026/02/17 |
| Last modified on | 2026/02/16 16:39:42 |
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Basic information
Public title
A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption
Acronym
A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption
Scientific Title
A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption
Scientific Title:Acronym
A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption
Region
| Japan |
Condition
Condition
Excessive drinking
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of providing drinking-related information and Commitment to Implementation on drinking behavior
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pure alcohol intake
Key secondary outcomes
Breath alcohol concentration (BrAC)
Blood pressure (BP)
Heart rate (HR)
Body temperature
Biphasic Alcohol Effects Scale (BAES)
Subjective High Assessment Scale
Perceived Cohesion Scale
Positive and Negative Affect Schedule
Visual Analogue Scales (e.g., satisfaction, etc)
Alcohol Hangover Severity Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provision of practical guidance on drinking behaviors and declaration of practice
Provision of alcohol-related knowledge
Interventions/Control_2
Provision of alcohol-related knowledge
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals who have consumed more than 100 g of pure alcohol in a single day without experiencing serious health problems at that time
2) Individuals who have consumed at least 60 g of pure alcohol in a single day on one or more occasions within the past month
3) Individuals who are able to participate in a group of three or more persons
4) Individuals who are not classified as flushers according to the flushing questionnaire
5) Individuals who can understand the study content and providing written informed consent
Key exclusion criteria
1) Individuals who are pregnant or breastfeeding
2) Individuals who are already intoxicated at the start of the trial
3) Individuals without decision-making capacity
4) Individuals with alcohol dependence
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yoshimoto |
Organization
Institute of Medicine
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba 305-8575
TEL
029-853-3101
hisashiyoshi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Yoshimoto |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba 305-8575
TEL
029-853-3101
Homepage URL
hisashiyoshi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Kirin Brewery Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba 305-8575
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
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Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 24 | 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 | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069408
