Screening and brief intervention using leaflets in annual healthcheckups at workplaces

JRCT ID: jRCT1060240002

Registered date:18/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Reducing risky alcohol drinking will be expected.
• Date of first enrollment: 07/05/2024
• Target sample size: 400
• Study type: Interventional
• Intervention(s): The study will consist of a 5-year intervention phase with screening after obtaining consent followed by annual interventions. Screening will be conducted at the time of consent acquisition using a web-based questionnaire, and enrollment will be conducted after confirming that selection criteria are met and that exclusion criteria are not violated. In the subsequent years, the AUDIT will be measured at the time of the medical checkup, and the same leaflet will be provided to both intervention and control groups at the time of notification of the results. Thereafter, measurement and intervention will be conducted continuously in conjunction with health checkups at workplaces, and long-term changes in drinking habits will be observed in the study subjects as a whole.

Outcome(s)

• Primary Outcome: Difference in the percentage increase in the negative alcohol use disorder screeners (those with an AUDIT <8 points) between the intervention and control groups at 12 months after the intervention

Secondary Outcome

- Mean AUDIT score
- Percentage of those with improved AUDIT scores
- Difference in the percentage increase in the AUDIT-C negative subjects (males: 6 points, females: 4 points or less)
- Percentage of those who improved their drinking and smoking habits at the time of annual health checkup interview
- Difference between the intervention group and the control group in the results of health examinations (BMI, abdominal circumference, blood pressure), and blood tests (AST/ALT/gamma GTP, blood sugar, serum lipid)
- Changes over time in AUDIT scores, drinking behavior, the results of health examination and blood test for the entire study participants

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Men and women who are 20 years old or older at the time consent is obtained
(2) People who have a drinking habit

• Exclude criteria: People receiving alcohol-related medical treatment (outpatient alcohol reduction or attendance at an institution specializing in addiction) within one month prior to obtaining consent.

Related Information

• Primary Sponsor: Kuwabara Yuki