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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name