Clinical Trial: A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption (Japan)

Tokyo, Feb. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060685) titled 'A Pilot Cluster Randomized Controlled Trial on the Impact of Providing Drinking Guidelines and Commitment to Implementation on Alcohol Consumption' on Feb. 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - University of Tsukuba

Condition: Condition - Excessive drinking Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To evaluate the effects of providing drinking-related information and Commitment to Implementation on drinking behavior Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Provision of practical guidance on drinking behaviors and declaration of practice Provision of alcohol-related knowledge Interventions/Control_2 - Provision of alcohol-related knowledge

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Individuals who have consumed more than 100 g of pure alcohol in a single day without experiencing serious health problems at that time 2) Individuals who have consumed at least 60 g of pure alcohol in a single day on one or more occasions within the past month 3) Individuals who are able to participate in a group of three or more persons 4) Individuals who are not classified as flushers according to the flushing questionnaire 5) Individuals who can understand the study content and providing written informed consent Key exclusion criteria - 1) Individuals who are pregnant or breastfeeding 2) Individuals who are already intoxicated at the start of the trial 3) Individuals without decision-making capacity 4) Individuals with alcohol dependence Target Size - 42

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 23 Day Date of IRB - 2026 Year 02 Month 13 Day Anticipated trial start date - 2026 Year 02 Month 18 Day Last follow-up date - 2026 Year 02 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069408

Disclaimer: Curated by HT Syndication.