Actively Recruiting
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2024-12-12
10000
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years). The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes. Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine. Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.
CONDITIONS
Official Title
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 50 to 70 years, females aged 55 to 75 years
- Drinkers consuming between 3 and 40 alcoholic drinks per week
- Projected life expectancy of more than 5 years based on physician judgment
- Willingness to receive advice on healthier alcohol consumption for up to 4 years
You will not qualify if you...
- No access to smartphone, computer, or tablet with internet connection
- Drinking less than 30 g or more than 400 g of pure alcohol per week
- Illiteracy, inability or unwillingness to give written consent or communicate with study staff, or inadequate skills to use online technologies
- Severe psychiatric conditions or diagnosis of cognitive impairment or dementia
- Presence of liver cirrhosis or previous liver cancer
- Diagnosis of breast cancer within the last 10 years
- Habitual use of high-dose medications that prevent any alcohol use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
M
Miguel A Martinez-Gonzalez, MD, MPH, PhD
CONTACT
M
Maira Bes-Rastrollo, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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