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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044486
Receipt No. R000050823
Scientific Title Changes in Alcohol Consumption Among a Population Who Underwent Medical Checkups During the First Wave of the Coronavirus Disease 2019 Pandemic in Japan: A Single-Center Retrospective Study
Date of disclosure of the study information 2021/06/09
Last modified on 2021/06/13

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Basic information
Public title Changes in Alcohol Consumption Among a Population Who Underwent Medical Checkups During the First Wave of the COVID-19 Pandemic in Japan: A Single-Center Retrospective Study
Acronym Changes in Alcohol Consumption Among a Population Who Underwent Medical Checkups During the First Wave of the COVID-19 Pandemic in Japan: A Single-Center Retrospective Study
Scientific Title Changes in Alcohol Consumption Among a Population Who Underwent Medical Checkups During the First Wave of the Coronavirus Disease 2019 Pandemic in Japan: A Single-Center Retrospective Study
Scientific Title:Acronym Changes in Alcohol Consumption Among a Population Who Underwent Medical Checkups During the First Wave of the Coronavirus Disease 2019 Pandemic in Japan: A Single-Center Retrospective Study
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Movement restrictions during the coronavirus disease 2019 (COVID-19) pandemic have inflicted stress and affected drinking behavior. However, limited information is available on the changes in alcohol use among the Japanese population. The present study investigated changes in alcohol consumption during the first wave of the COVID-19 pandemic in Japan.
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in alcohol consumption before (April 1, 2019 to December 31, 2019) and during the COVID-19 pandemic (April 1, 2020 to May 31, 2020)
Key secondary outcomes Risk factors associated with increased drinking

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 Subjects who underwent medical checkups at Fuyoukai Murakami Hospital, Aomori city, Japan before (from April 1, 2019 to December 31, 2019) and during the COVID-19 pandemic (from April 1, 2020 to May 31, 2020)
Key exclusion criteria None
Target sample size 350

Research contact person
Name of lead principal investigator
1st name Yusaku
Middle name
Last name Kajihara
Organization Fuyoukai Murakami Hospital
Division name Department of Gastroenterology
Zip code 030-0843
Address 3-3-14 Hamada, Aomori, Japan
TEL +81-17-729-8888
Email y_kaji2012@yahoo.co.jp

Public contact
Name of contact person
1st name Yusaku
Middle name
Last name Kajihara
Organization Fuyoukai Murakami Hospital
Division name Department of Gastroenterology
Zip code 030-0843
Address 3-3-14 Hamada, Aomori, Japan
TEL +81-17-729-8888
Homepage URL
Email y_kaji2012@yahoo.co.jp

Sponsor
Institute Fuyoukai Murakami Hospital
Institute
Department

Funding Source
Organization Fuyoukai Murakami Hospital
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 Fuyoukai Murakami Hospital
Address 3-3-14 Hamada, Aomori, Japan
Tel +81-17-729-8888
Email y_kaji2012@yahoo.co.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 06 Month 09 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 371
Results In total, 25.1% subjects increased their alcohol intake and 24.5% subjects reduced their alcohol intake.

Multivariate analysis identified only age (49 years or less) as a risk factor for increased drinking (adjusted odds ratio, 2.20; 95% confidence interval, 1.22-3.99; p = 0.009).
Results date posted
2021 Year 06 Month 09 Day
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 Completed
Date of protocol fixation
2021 Year 02 Month 10 Day
Date of IRB
2021 Year 03 Month 01 Day
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2021 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Methods:
The following characteristics extracted from medical records were analyzed: age, sex, drinking behavior, instruction for alcohol restriction, medication for lifestyle-related diseases (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, and hyperuricemia), mental illness, occupation, and tobacco habit. Changes in alcohol consumption (grams of ethanol per day) were investigated and divided into three categories: increased drinking, no change, and decreased drinking.

In addition, a logistic regression model was used to identify the risk factors associated with increased drinking, and seven variables were sequentially introduced into the model-age (49 years or less), male sex, prior instructions for alcohol restriction, medication for lifestyle-related diseases, depression or insomnia, essential workers, and smoking.

Statistical analysis was performed using EZR (easy R, version 1.54), and p < 0.05 was considered statistically significant.

Management information
Registered date
2021 Year 06 Month 09 Day
Last modified on
2021 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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