UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050580 |
|---|---|
| Receipt number | R000057139 |
| Scientific Title | Randomized controlled trial for implementation of ALDH2 genotyping in the healthcare system |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2026/01/07 17:04:13 |
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Basic information
Public title
Evaluation of ALDH2 genotyping for health promotion
Acronym
AGHP
Scientific Title
Randomized controlled trial for implementation of ALDH2 genotyping in the healthcare system
Scientific Title:Acronym
AGHP
Region
| Japan |
Condition
Condition
Undesirable lifestyle habits
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To test whether notification of the rs671 polymorphism of the aldehyde dehydrogenase gene (ALDH2) can promote behavioral changes in lifestyle habits. This will demonstrate the usefulness of ALDH2 rs671 polymorphism determination and provide evidence for dissemination and implementation of the testing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of drinking, amount of drinking, frequency of heavy drinking, stages of behavioral modification, perceptions of drinking habits, and stress coping
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Notification of ALDH2 gene rs671 polymorphism and sharing of health information related to rs671
Interventions/Control_2
Notification of ALDH2 gene rs671 polymorphism and sharing of health information related to rs671
Acetaldehyde exposure marker testing and objective sleep assessment
Interventions/Control_3
Notification of ALDH2 gene rs671 polymorphism and sharing of health information related to rs671 at the end of the observation period
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Employees of workplaces in Saga Prefecture.
Key exclusion criteria
(1) Those who are not receiving treatment for a serious physical or mental illness
(2) Those who are receiving sleep treatment for depression or mental illness.
(3) Those who are unable to participate in the entire survey due to their existing commitments.
(4) Other subjects deemed inappropriate by the industrial physician at their workplace.
(5) Those who have requested discontinuation of the study (those who have submitted a consent withdrawal form).
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Matsumoto |
Organization
Saga University
Division name
School of Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima
TEL
0952342289
matsumoa@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Tokiya |
Organization
Saga University
Division name
School of Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952342289
Homepage URL
https://sagasocialmed.med.saga-u.ac.jp/research/aldh%EF%BC%92%E3%81%AE%E5%9E%8B%E3%81%AB%E5%BF%9C%E3
matsumoa@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Akiko Matsumoto
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
5-1-1 Nabeshima Saga
Tel
0952-31-6511
matsumoa@cc.saga-u.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
| 2023 | Year | 04 | Month | 01 | 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
Results
A genotype-disclosure intervention for rs671 showed a non-significant decreasing trend in occasional alcohol consumption in the variant group (p = 0.157). In the disclosure arm, sex- and age-adjusted geometric means changed from 3.4 to 3.9 drinks (wild type) and from 2.1 to 1.9 drinks (variant). In the non-disclosure arm, wild type changed from 2.6 to 1.7 drinks and variant from 3.5 to 3.2 drinks. Presented at the 95th Annual Meeting of the Japan Society of Public Health (2025).
Results date posted
| 2026 | Year | 01 | Month | 07 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Results were similar to previous studies and no significant differences were observed. This may be attributable to the study being conducted at health screening facilities with many participants having favorable baseline lifestyle habits, occupational homogeneity, and an insufficient sample size. Participant recruitment and data collection are ongoing, so publication of the final results is expected to be delayed.
Date of the first journal publication of results
Baseline Characteristics
We investigated the effect of awareness of the rs671 polymorphism on lifestyle behaviors and health-related perceptions by leveraging health-check opportunities in medical facilities, workplaces, and communities. The study was conducted at a health screening center in Saga Prefecture from 2023 to 2024 and enrolled 107 participants. The protocol was approved by the Saga University Ethics Committee (R4-30, R5-15).
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057139
