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Unguided Web-Based Brief Intervention with Genetic Risk Education to Reduce Unhealthy Alcohol Consumption: Protocol for a Randomized Controlled Trial

Kono, Y.; Tanaka Sahker, M.; Kikuchi, S.; Luo, Y.; Sakata, M.; So, R.; Wall, T. L.; Furukawa, T. A.; Sahker, E.

2025-07-11 psychiatry and clinical psychology
10.1101/2025.07.10.25331236 medRxiv
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BackgroundAlcohol use is one of the largest worldwide contributors to morbidity and mortality, and a major risk factor for esophageal cancer. Reducing or stopping alcohol use results in a significant esophageal cancer risk reduction. A causal factor in alcohol-related esophageal cancer is exposure to acetaldehyde, an alcohol metabolite and established carcinogen. Japanese people have a high proportion of the aldehyde dehydrogenase 2*2 (ALDH2*2) allele, which causes a deficiency in ALDH2 enzyme activity and increases exposure to acetaldehyde, elevating their risks of esophageal cancer. Personalized health information about such risks can be important in developing motivation to moderate alcohol consumption. Fortunately, brief intervention (BI) for unhealthy alcohol use is an effective behavioral intervention that can capitalize on this motivation source but is underused in Japan. ObjectivesThe proposed project will test the efficacy of an unguided web-based BI using genetic cancer risk education to reduce alcohol consumption in a randomized controlled trial. MethodsParticipants will be recruited online and screened for moderate alcohol use and probable ALDH2*2 allele. Included participants will be randomized to an experimental BI condition or sham educational control. The experimental condition will receive an unguided web-based brief video intervention. The intervention will educate participants about their probable genetic risk, how consuming alcohol significantly increases risk of esophageal cancers, and the benefits of reducing or stopping alcohol use. The primary outcome is mean endpoint past 4-week alcohol quantity at 3-months post-randomization. Additionally, secondary main effects will be investigated with alcohol use in grams, severity, motivation to change, health knowledge retention, participant satisfaction, and quality of life. Assessments will be collected at baseline, 1- , 2-, and 3-months post-randomization through a web portal. ResultsThe present study was funded in April 2024. Data collection is projected to occur August 2025 - August 2026 through a Japanese research panel company. Currently, no data has been collected. ConclusionsThis intervention is expected to reduce unhealthy alcohol use at a low cost of implementation by using personalized health information as a motivational factor in a general population. Additional group differences are expected to be observed in secondary alcohol use outcomes. Trial RegistrationThis trial has been registered in University Hospital Medical Information Network Clinical Trials Registry (UMIN000058012).

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