NCT06338215Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10000 (estimated)
- First submitted
- 13 Mar 2024
- Start date
- 15 May 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Diseases
- Tuberculosis, Type 2 diabetes
- NCT number
- NCT06338215
What you commit to
- Study type: Interventional
- Planned participants: 10000
- From 15 May 2024 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.