UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036244 |
|---|---|
| Receipt number | R000041282 |
| Scientific Title | A study to examine the effectiveness of brief intervention programs that help reduce alcohol consumption using health guidance opportunities at business establishments and universities |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2023/09/20 09:40:00 |
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Basic information
Public title
A Study on the Effectiveness of the Intervention of Alcohol Reduction Support Program Using the Opportunity of Health Guidance in Workplaces
Acronym
A study to examine the effectiveness of interventions to support alcohol reduction
Scientific Title
A study to examine the effectiveness of brief intervention programs that help reduce alcohol consumption using health guidance opportunities at business establishments and universities
Scientific Title:Acronym
A randomized controlled trials to verify the effectiveness of interventions to help reduce alcohol consumption
Region
| Japan |
Condition
Condition
problem drinking
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an effect of the brief intervention for problem drinker
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A change in alcohol consumption amount per week (gram of pure alcohol per week)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral instruction (15 minutes)
Interventions/Control_2
Oral instruction (5 minutes)
Interventions/Control_3
Delivery of a brochure
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Person with AUDIT score 8 points or more
Key exclusion criteria
Patients with alcohol dependence, pregnant woman
Target sample size
351
Research contact person
Name of lead principal investigator
| 1st name | Yoneatsu |
| Middle name | |
| Last name | Osaki |
Organization
Tottori University, Faculty of Medicine
Division name
Division of environmental and preventive medicine
Zip code
6838503
Address
Nishi-cho 86, Yonago, Tottori, Japan
TEL
+81859386103
yoneatsu@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoneatsu |
| Middle name | |
| Last name | Osaki |
Organization
Tottori University, Faculty of Medicine
Division name
Division of environmental and preventive medicine
Zip code
683-8503
Address
Nishi-cho 86, Yonago, Tottori
TEL
+81859386103
Homepage URL
yoneatsu@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
11070
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University, Faculty of Medicine
Address
Nishi-cho 86
Tel
+81859386103
yoneatsu@tottori-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
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://mhlw-grants.niph.go.jp/niph/search/NIDD02.do?resrchNum=201809016A
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/acer.14909
Number of participants that the trial has enrolled
351
Results
Subjects were assigned to three groups: the control group, a five-minute intervention (UBI group) and a 15-minute intervention group (BI group) The mean change in weekly alcohol consumption at six months was -38.1 g in the BI group, significantly different from the control group The reduction in the BI group persisted at the 12-month follow-up but was no longer significantly different from the control group. Reductions in the frequency of drinking and binge drinking were observed in all three groups.
Results date posted
| 2023 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 08 | Month | 02 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041282
