UMIN-CTR Clinical Trial

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
Email	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
Email	Tadori.Yoshihiro@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049138