Effectiveness of Providing Educational Leaflet after Screening on Hazardous and Harmful Alcohol Use in the Workplace: Study Protocol for a Randomized Controlled Trial.

Background: Despite evidence regarding the effectiveness of screening and brief interventions for excessive alcohol consumption, these interventions are not widely used. Although several studies have suggested that face-to-face interventions in the workplace may be effective, developing an implementable intervention strategy for alcohol users, including light drinkers, is warranted. This study aimed to develop a study protocol to evaluate the effect of providing an educational leaflet at the workplace on reducing hazardous or harmful alcohol use.

Methods: A randomized controlled trial involving employees (aged ≥ 20 years) of a local administrative office in Japan who were screened using the Alcohol Use Disorder Identification Test (AUDIT) is ongoing. Participants were randomized into "Educational leaflet" and "Control (no intervention)" groups. The primary outcome was the difference in negative status on the AUDIT (proportion of participants scoring < 8 points on the AUDIT) between the intervention and control groups in the following year. For the secondary outcomes, laboratory marker data at annual health checkups were collected and assessed.

Results: A total of 400 participants were randomized into educational leaflet (n = 200) and control (n = 200) groups. The basic characteristics of all participants included sex (men 79.3%; women 20.8%), mean (standard deviation) of age 48.5 (9.7 years), 40.0% of AUDIT ≥ 8 points, 46.8% of drinking alcohol ≥ 4 times a week, and 33.8% of heavy episodic drinking. No significant differences were observed between the intervention and control groups in terms of the baseline variables.

Conclusions: This study protocol developed the first trial in Japan to investigate the impact of providing an educational leaflet after screening for hazardous and harmful alcohol use in a workplace setting. The findings of this study can provide the first evidence that an implementable alcohol intervention strategy targeting alcohol users, including light drinkers in the workplace, is effective in reducing hazardous or harmful alcohol use.