Unguided web-based brief intervention with genetic risk education to reduce unhealthy alcohol consumption in Japan: Protocol for a randomized controlled trial

BACKGROUND: Alcohol consumption is a major global contributor to morbidity and mortality and is a well-established risk factor for multiple cancers. Acetaldehyde, a toxic metabolite of ethanol, is a causal factor in alcohol-related esophageal cancer. A substantial proportion of the Japanese population carries the aldehyde dehydrogenase 2*2 (ALDH2*2) allele, which impairs ALDH2 enzymatic activity and increases acetaldehyde exposure, thereby elevating esophageal cancer risk. Among individuals with the ALDH2*2 allele, cancer risk demonstrates a clear dose-response relationship with alcohol consumption, with relative risks reported to be up to four times the relative risk, compared to non-carriers. OBJECTIVES: This project aims to evaluate the efficacy of an unguided, web-based brief intervention (BI) incorporating genetic cancer-risk education to reduce alcohol consumption in a randomized controlled trial. METHODS: Participants will be recruited online between March and July 2026 through a Japanese research panel company. Eligibility will include moderate alcohol use and probable ALDH2*2 allele status. Participants will be randomized to either an experimental condition or a sham educational control. The experimental group will receive an unguided, web-based, brief video intervention providing information on genetic cancer risks associated with alcohol consumption and the benefits of reducing drinking. The primary outcome will be mean past-4-week alcohol quantity at the 3-month endpoint. Secondary outcomes will include alcohol use in grams, alcohol-related severity, motivation to change, health-knowledge retention, participant satisfaction, and quality of life. Assessments will occur at baseline and at 1, 2, and 3 months post-randomization via a secure web portal. DISCUSSION: This intervention is expected to reduce unhealthy alcohol use at low implementation cost by leveraging personalized genetic risk information as a motivational mechanism in the general population. Additional between-group differences are anticipated across secondary alcohol-related outcomes. Trial Registration: This trial registered on 11/28/2025 in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000058012).

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Publication Details

Journal
PLoS ONE
Published
2026-04-17
DOI
https://doi.org/10.1371/journal.pone.0347064
Primary Topic
Alcohol Consumption and Health Effects
Type
article
Field-Weighted Citation Impact
0.00

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article

Unguided web-based brief intervention with genetic risk education to reduce unhealthy alcohol consumption in Japan: Protocol for a randomized controlled trial

Shino Kikuchi, Tamara L. Wall, Masatsugu Sakata, Ethan Sahker et al.
PLoS ONE
Alcohol Consumption and Health Effects
article

Unguided web-based brief intervention with genetic risk education to reduce unhealthy alcohol consumption in Japan: Protocol for a randomized controlled trial

Shino Kikuchi, Tamara L. Wall, Masatsugu Sakata, Ethan Sahker, Ryuhei So, Yan Luo, Toshi A. Furukawa, Mai Tanaka-Sahker, Yuki Kono
article en

Abstract

BACKGROUND: Alcohol consumption is a major global contributor to morbidity and mortality and is a well-established risk factor for multiple cancers. Acetaldehyde, a toxic metabolite of ethanol, is a causal factor in alcohol-related esophageal cancer. A substantial proportion of the Japanese population carries the aldehyde dehydrogenase 2*2 (ALDH2*2) allele, which impairs ALDH2 enzymatic activity and increases acetaldehyde exposure, thereby elevating esophageal cancer risk. Among individuals with the ALDH2*2 allele, cancer risk demonstrates a clear dose-response relationship with alcohol consumption, with relative risks reported to be up to four times the relative risk, compared to non-carriers. OBJECTIVES: This project aims to evaluate the efficacy of an unguided, web-based brief intervention (BI) incorporating genetic cancer-risk education to reduce alcohol consumption in a randomized controlled trial. METHODS: Participants will be recruited online between March and July 2026 through a Japanese research panel company. Eligibility will include moderate alcohol use and probable ALDH2*2 allele status. Participants will be randomized to either an experimental condition or a sham educational control. The experimental group will receive an unguided, web-based, brief video intervention providing information on genetic cancer risks associated with alcohol consumption and the benefits of reducing drinking. The primary outcome will be mean past-4-week alcohol quantity at the 3-month endpoint. Secondary outcomes will include alcohol use in grams, alcohol-related severity, motivation to change, health-knowledge retention, participant satisfaction, and quality of life. Assessments will occur at baseline and at 1, 2, and 3 months post-randomization via a secure web portal. DISCUSSION: This intervention is expected to reduce unhealthy alcohol use at low implementation cost by leveraging personalized genetic risk information as a motivational mechanism in the general population. Additional between-group differences are anticipated across secondary alcohol-related outcomes. Trial Registration: This trial registered on 11/28/2025 in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000058012).

PLoS ONEVol. 21(4)
Kyoto University (JP), Nihon Kohden (Japan) (JP), Nagoya City University (JP), University of California San Diego (US), Okayama Psychiatric Medical Center (JP), Scientific Research WorkS Peer Support Group
Shionogi, Nagoya City University, Japan Society for the Promotion of Science, Daiichi Sankyo Europe
Good health and well-being
Openalex Percentile: Top 20%
Alcohol Consumption and Health Effects
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