UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043043 |
|---|---|
| Receipt number | R000049138 |
| Scientific Title | Internet usage questionnaire survey on behavioral change after viewing the website "gen-shu.jp" of drinkers enhancing the risk of lifestyle-related diseases |
| Date of disclosure of the study information | 2021/01/18 |
| Last modified on | 2021/10/28 23:48:10 |
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Basic information
Public title
Internet usage questionnaire survey on behavioral change after viewing the website "gen-shu.jp" of drinkers enhancing the risk of lifestyle-related diseases
Acronym
Internet usage questionnaire survey on behavioral change after viewing the website "gen-shu.jp"
Scientific Title
Internet usage questionnaire survey on behavioral change after viewing the website "gen-shu.jp" of drinkers enhancing the risk of lifestyle-related diseases
Scientific Title:Acronym
Internet usage questionnaire survey on behavioral change after viewing the website "gen-shu.jp"
Region
| Japan |
Condition
Condition
alcohol consumption
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of behavioral changes after viewing the website "gen-shu.jp" of drinkers enhancing the risk of lifestyle-related diseases (drinker of 40g/day or more male and 20g/day or more female: risk drinker), risk drinkers who have weekly or more drinking alcohol control problem (risk drinkers who have drinking alcohol control problem), and risk drinkers who have been advised to refrain from alcohol by others during the last year (risk drinkers who has been worried about drinking by others).
Basic objectives2
Others
Basic objectives -Others
Internet usage questionnaire survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Behavior change hope incidence rate of immediately after the viewing of the website
Key secondary outcomes
Rate of change without intention to reduce alcohol, rate of change without intention to consult, rate of change without intention to treat, rate of transition to correct answer of risk drinking levels for men and women, and rate of risk-free drinkers 1 month after viewing website
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Website "gen-shu.jp" unviewed panels view the three items on the website "gen-shu.jp"
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
Drinkers enhancing the risk of lifestyle-related diseases (drinkers of 40g/day or more male and 20g/day or more female: risk drinkers)
Risk drinkers who have weekly or more drinking alcohol control problem (risk drinkers who have drinking alcohol control problem)
risk drinkers who have been advised to refrain from alcohol by others during the last year (risk drinkers who have been worried about drinking by others).
Key exclusion criteria
Subjects who have viewed the website "gen-shu.jp" before the study.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Izuru |
| Middle name | |
| Last name | Nakamura |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
070-3537-2918
Nakamura.Izuru@otsuka.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tadori |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
080-8720-3458
Homepage URL
Tadori.Yoshihiro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Imaizumi.Takashi@otsuka.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
| 2021 | Year | 01 | Month | 18 | 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
923
Results
Behavior change hope incidence rate of immediately after the viewing of the website " gen-shu.jp " (selection: to reduce alcohol consumption, seek consultation with a doctor, seek a hospital, want to receive treatment of alcohol consumption reduction, want to receive abstinence treatment, seek consultation with a non-doctor) was 52.3% [n=523: 34.4% (n=142) in the risk drinker group, 60.8% (n=225) in the drinking control problem group, and 71.9% (n=156) in the group of drinker worried by others].
Results date posted
| 2021 | Year | 10 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
The answer of the second survey was obtained from the first survey respondent one month later.
Adverse events
This study was a questionnaire without a free entry column, and adverse events and safety information were not collected.
Outcome measures
Questionnaire item
1.Drinking Behavior
Decision: Intention to reduce alcohol consumption, intention to consult, desire to change behaviors, intention to treat
Amount of alcohol and frequency of drinking: frequency of drinking, amount of drinking, risk drinking, and drinking control problems
Derived from heavy drinking: drinking worried by others, awareness of drinking problems, Own alcohol dependence stage, and AUDIT
Knowledge: amount of low risk drinking levels for male and female
2.Web browsing
Browsing of "gen-shu.jp" after the first survey
Use of application that "gen-shu diary " (record the date of drinking, the type of alcohol, the amount of alcohol consumption, etc.)
3.Demographic characteristics, etc.
Sex
Age
Browsing of "gen-shu.jp"
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049138
