Recruiting

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

ClinicalTrials.gov IDNCT06338215

PhaseNA

Enrollment10000

SponsorClinica Universidad de Navarra, Universidad de Navarra

Age50 Years

SexALL

I'm interested View official listing

Conditions studied

All Cause Mortality, Cardiovascular Diseases, Invasive Cancer, Liver Cirrhosis, Type 2 Diabetes, Depression, Dementia, Injury Traumatic, Tuberculosis, Infections

About this study

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.

Interventions

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 — 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.

Primary outcomes

Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases (From enrollment to the end of the intervention up to 4 years.)

Eligibility information

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.

Study locations

University of Navarra, Pamplona, Navarre 31008 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.