UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044148 |
|---|---|
| Receipt number | R000050379 |
| Scientific Title | Examination of simple intervention using genetic polymorphism information for excessive drinking |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/05/29 03:18:06 |
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Basic information
Public title
Examination of simple intervention using genetic constitution information of alcohol-metabolizing enzyme for excessive drinking
Acronym
Examination of intervention for excessive drinking constitutional information of alcohol-metabolizing enzymes
Scientific Title
Examination of simple intervention using genetic polymorphism information for excessive drinking
Scientific Title:Acronym
Examination of intervention using genetic polymorphism information for excessive drinking
Region
| Japan |
Condition
Condition
Excessive drinking that increases the risk of lifestyle-related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will study individual simple intervention methods by providing information on enzyme-active types of ALDH2 and ADH1B in young adults with excessive drinking, and verify their efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average amount of alcohol consumed per day when drinking
Key secondary outcomes
Stage of Change in drinking behavior, Health care and sleep and fatigue status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Gene | Behavior,custom |
Interventions/Control_1
Intervention group:Intervention materials and notification of alcohol constitution test results
Interventions/Control_2
Control group:Alcohol Handbook (conventional teaching materials)
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Research participants at the University of Tsukuba (university students, graduate students, staff)
2. Drinkers who drink more than the average amount of alcohol per day increases the risk of lifestyle-related diseases (4 drinks for men = 40g of pure alcohol, 2 drinks for women = 20g of pure alcohol)
Key exclusion criteria
1. Those who do not want to know the result of the alcohol constitution test
2. Those who have difficulty communicating in Japanese
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yoshimoto |
Organization
University of Tsukuba
Division name
Faculty of medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba 305-8575
TEL
029-853-3101
hisashiyoshi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Owaki |
Organization
University of Tsukuba
Division name
Faculty of medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba 305-8575
TEL
029-853-3101
Homepage URL
Oowaki.yuki@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sanwa Shurui Company, Sanwa Laboratory
Name of secondary funder(s)
Sanwa Shurui Company, Sanwa Laboratory
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
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36028843/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38769537/
Number of participants that the trial has enrolled
196
Results
This open-label, randomized, controlled trial included college students and faculty aged 20-30 years, with an average net alcohol consumption of at least 40 g/day for men and 20 g/day for women (n=196); the intervention group (n=100) was provided information on alcohol metabolizing enzymes (ALDH2 and ADH1B). The effects of the intervention were confirmed by reductions in alcohol consumption and AUDIT-C scores, and an increase in the percentage moving from "precontemplation" to "contemplation" or "action".
Results date posted
| 2024 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 20 | Day |
Baseline Characteristics
Participants had the following backgrounds: (1) University of Tsukuba undergraduate students, graduate students, faculty and staff, (2) excessive drinking habits (average daily alcohol consumption in g of pure alcohol: 40 g or more for males and 20 g or more for females on drinking days, (3) adults aged 20-30 years, (4) no health problems in daily life, studies or employment and no history of prior or current illness.
The mean age at baseline was 22.5 (20-30) years, 85 (43.4%) were male and 111 (56.6%) were female. The positions of the participants were 124 (63.3%) undergraduate students, 46 (23.4%) graduate students, and 26 (13.3%) faculty members. Drinking status was defined as AUDIT-C score (mean 5.7), AUDIT score (mean 8.8), and average daily alcohol consumption (43.7 g of pure alcohol) on the days of drinking.
Participant flow
The final enrollment was 204 participants, with four withdrawing during the post-enrollment period (three because they were too busy to drink and one because his physician indicated alcohol-related illness and instructed him to stop drinking), and four who could not be contacted during the study period were excluded from the analysis and were assigned by a simple randomization method. There were 100 participants in the intervention group and 96 in the control group.
The intervention group received an individualized brief intervention on drinking habits (a genetic test for alcohol-metabolizing enzymes using saliva at the time of enrollment, and a brief intervention based on the test results and drinking records about one month later).
The control group did not undergo genetic testing during the study period and was provided only with the conventional educational material "Alcohol Handbook for College Students" for follow-up.At the end of the study period, the control group was offered genetic testing upon request, and the test results were mailed to the individual.
Adverse events
There were no specific adverse events observed or reported during the study period.
Outcome measures
Average daily alcohol consumption on drinking days (in g of pure alcohol), Alcohol Use Disorders Identification Test (AUDIT-C), Behavioral Stage of Change (TTM: Transtheoretical model)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Protocol published.
https://pubmed.ncbi.nlm.nih.gov/36028843
Publication of papers on results
https://pubmed.ncbi.nlm.nih.gov/38769537/
Management information
Registered date
| 2021 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050379
