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A brief intervention to promote health behaviors: A randomized controlled trial.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058012
Enrollment
100
Registered
2025-05-29
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese adults with ALDH2*2 genotype who drink alcohol at moderate levels

Interventions

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 conten

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Current alcohol use treatment 2. Lifetime cancer diagnosis 3. Pregnant

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactEthan Sahker

Kyoto University Graduate School of Medicine Population Health and Policy Research Unit, Center for Medical Education and Internationalization

sahker.ethan.2e@kyoto-u.ac.jp075-753-9292

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026