UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058012 |
|---|---|
| Receipt number | R000066312 |
| Scientific Title | Unguided Web-Based Brief Intervention with Genetic Risk Education to Reduce Unhealthy Alcohol Consumption: Protocol for a Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/29 15:01:13 |
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Basic information
Public title
A brief intervention to promote health behaviors: A randomized controlled trial.
Acronym
BIGRE Trial
Scientific Title
Unguided Web-Based Brief Intervention with Genetic Risk Education to Reduce Unhealthy Alcohol Consumption: Protocol for a Randomized Controlled Trial
Scientific Title:Acronym
BIGRE Trial
Region
| Japan |
Condition
Condition
Japanese adults with ALDH2*2 genotype who drink alcohol at moderate levels
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Alcohol use is one of the leading causes of disease burden worldwide and a major risk factor for esophageal cancer for those with the aldehyde dehydrogenase 2*2 (ALHD2*2) genotype. Reducing alcohol consumption can significantly reduce the risks of developing esophageal cancer. The present study will investigate the efficacy of a non-invasive and unguided web-based brief intervention (BI) using genetic risk education (BIGRE) to moderate alcohol consumption in the Japanese general population. This approach presents less costly and more scalable intervention approaches, reducing healthcare system burdens.
Basic objectives2
Others
Basic objectives -Others
To inform future iterations of unguided web-based BI interventions in terms of development and feasibility.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean endpoint past 4-week alcohol quantity at 3 months post-randomization, measured in the number of standard drinks with the Daily Drinking Questionnaire (DDQ).
Key secondary outcomes
Secondary outcomes include the quantity or standard drinks at 1- and 2-month follow-ups; alcohol use in grams, severity, motivation to change, health knowledge retention, and quality of life at 1-, 2-month, and 3-month follow-ups post-randomization. Participant satisfaction will be measured after the intervention program has been delivered.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
BIGRE Intervention Group
BIGRE consists of an animated educational video with a host medical doctor avatar voiced by a professional voice-over artist. It provides spoken information, animated content, and graphical depictions of graphs, charts, and genetic processes. The components will emphasize that they are likely ALDH2*2 carriers, they have an increasing risk for specific cancers with increased alcohol consumption, and reducing alcohol consumption reduces the risk of developing alcohol-related cancers.
Interventions/Control_2
Sham Control Group
The control group will receive a sham attention control video that describes the importance of quality of life (QoL) and health, description of QoL concepts, and ways to change health behaviors to improve QoL. The sham control intervention consists of an animated educational video with a host medical doctor avatar voiced by a professional voice-over artist. It provides spoken information and animated content. The video will last 6 minutes.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 20 to 64 years of age
2. At least 4 alcohol drinks per week on average
3. Positive screening for probable ALDH2*2 allele
Key exclusion criteria
1. Current alcohol use treatment
2. Lifetime cancer diagnosis
3. Pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ethan |
| Middle name | Kyle |
| Last name | Sahker |
Organization
Kyoto University Graduate School of Medicine
Division name
Population Health and Policy Research Unit, Center for Medical Education and Internationalization
Zip code
606-8501
Address
Faculty of Medicine Campus, Bldg E, Rm 109
TEL
075-753-9292
sahker.ethan.2e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ethan |
| Middle name | Kyle |
| Last name | Sahker |
Organization
Kyoto University Graduate School of Medicine
Division name
Population Health and Policy Research Unit, Center for Medical Education and Internationalization
Zip code
606-8501
Address
Faculty of Medicine Campus, Bldg E, Rm 109
TEL
075-753-9292
Homepage URL
sahker.ethan.2e@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (24K20239)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-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
| 2025 | Year | 05 | Month | 29 | 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
Results date posted
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | 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=R000066312
