Tests moderate drinking advice against advice to abstain from alcohol
Compares moderate Mediterranean drinking advice with abstention advice in Spanish adult drinkers.
Plain-language title generated from the registry record
Registry title: Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
Key facts
- Where
- Pamplona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Source: NCT06338215, who can take part
Where in Spain
- University of NavarraPamplona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinica Universidad de Navarra, Universidad de Navarra
- Trial code
- NCT06338215
- Record updated
- 12 December 2024
- Original description
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).Read full original descriptionShow less
A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
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.
Inclusion: 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: Participants with liver cirrhosis or prior liver cancer; 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; Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia; Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years); 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.