RecruitingNot ApplicableNCT06338215

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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Enrollment

10,000 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether drinking in moderation — rather than stopping completely — can reduce the health risks linked to alcohol in people who currently drink regularly. You may be eligible if: - You are a man between 50 and 70 years old, or a woman between 55 and 75 years old - You currently drink alcohol (between 3 and 40 drinks per week) - Your doctor believes you are likely to live at least 5 more years - You are willing to receive online guidance about alcohol habits for up to 4 years You may NOT be eligible if: - You do not have a smartphone, computer, or tablet with internet access - You drink fewer than about 4 drinks per week or more than about 50 drinks per week - You are not able or willing to read or use online tools - You have a severe mental health condition, or have been diagnosed with memory loss or dementia - You have liver cirrhosis or a history of liver cancer - You were diagnosed with breast cancer in the last 10 years - You regularly take high-dose medications that completely prevent any alcohol use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALModerate 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.

BEHAVIORALAbstention