RECRUITINGINTERVENTIONAL

Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: 1. Participants without smartphone or a computer (or tablet) with Internet connection. 2. Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk 3. Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies 4. Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia. 5. Participants with liver cirrhosis or prior liver cancer. 6. Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years). 7. Patients under habitual use of high-dose medications that completely preclude any use of alcohol. Most of these patients will be already excluded by the second or fourth exclusion criteria. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: 1. Participants without smartphone or a computer (or tablet) with Internet connection. 2. Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk 3. Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies 4. Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia. 5. Participants with liver cirrhosis or prior liver cancer. 6. Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years). 7. Patients under habitual use of high-dose medications that completely preclude any use of alcohol. Most of these patients will be already excluded by the second or fourth exclusion criteria.

Treatments Being Tested

BEHAVIORAL

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.

BEHAVIORAL

Abstention

Locations (1)

University of Navarra

Pamplona, Navarre, Spain