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.
Males aged 50-70 years, Women aged 55-75 years
Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
Projected life expectancy more than 5 years (according to the judgment of their attending physician)
Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
Participants without smartphone or a computer (or tablet) with Internet connection.
Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
Parallel
Moderate Alcohol Drinking Pattern
BehavioralRemotely 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
BehavioralRemotely 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.
Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases
Global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission, tuberculosis or other infections requiring hospitalization evaluated from the information on clinical records.
Comparison between groups of the incidence of the most severe outcomes
The most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less sever outcomes, using ad hoc methods, using information on clinical records.
Comparison between groups of invasive cancer incidence with extended follow-up
The trial may not be long enough to observe effects on cancer endpoints. Therefore, a comparison between groups of cancer incidence endpoints after 10-year follow-up, assessed through the information on clinical records, will be included as an ancillary analysis.
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