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Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Summary
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.
Official title: A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2024-05-15
Completion Date
2029-06-30
Last Updated
2024-12-12
Healthy Volunteers
Yes
Conditions
Interventions
Moderate Alcohol Drinking Pattern
Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: 1. moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml). 2. always during meals 3. spread out throughout the whole week, and 4. avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake.
Abstention
Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: Abstention. Message of 0 alcohol.
Locations (1)
University of Navarra
Pamplona, Navarre, Spain