UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050304 |
|---|---|
| Receipt number | R000057235 |
| Scientific Title | Qualitative research to investigate factors influencing changes in alcohol consumption |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2024/04/19 13:07:29 |
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Basic information
Public title
Qualitative research to investigate factors influencing changes in alcohol consumption
Acronym
Qualitative research to investigate factors influencing changes in alcohol consumption
Scientific Title
Qualitative research to investigate factors influencing changes in alcohol consumption
Scientific Title:Acronym
Qualitative research to investigate factors influencing changes in alcohol consumption
Region
| Japan |
Condition
Condition
Excessive drinking that increases the risk of lifestyle-related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence factors on change of amount of alcohol consumption
Basic objectives2
Others
Basic objectives -Others
To clarify the impression on non-alcohol beverages and the possibility of continuous use of those
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics of factors influencing on change of alcohol consumption
Key secondary outcomes
Impression on non-alcohol beverages and the possibility of continuous use of those
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
The persons who offer to participate in this study who cooperated with our randomized controlled study on the impact of serving non-alcoholic beverages on alcohol consumption (hereinafter called non-alcohol study).
and meet the following conditions,
1) The case to be confirmed significant reduction in alcohol consumption using non-alcohol beverage
2) The case not to be confirmed significant reduction in alcohol consumption using non-alcohol beverage
3) The case to be confirmed significant reduction in alcohol consumption without using non-alcohol beverage
4) The case not to be confirmed significant reduction in alcohol consumption without using non-alcohol beverageThe
Key exclusion criteria
non-consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yoshimoto |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba
TEL
029-853-1019
hisashiyoshi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Ohata |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba
TEL
029-853-1019
Homepage URL
lifestyle-tsukuba@un.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, R&D Center for Lifestyle Innovation
Institute
Department
Personal name
Funding Source
Organization
ASAHI BREWERIES, LTD.
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 10 | 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
21
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Method: Qualitative research
Study period: February 13 to May 31, 2023
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
