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

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT06338215
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Moderate Alcohol Drinking Pattern — BEHAVIORAL
    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.
  • Abstention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Mar 29, 2024
Start date
May 15, 2024
Status verified
Mar 2024
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
10,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Moderation
    Advice about alcohol intake following a Mediterranean Alcohol Drinking Pattern: Moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, consumption of alcohol with meals and preference for red wine.
  • Active Comparator: Abstention
    Advice on alcohol abstention.

Primary Outcome Measure

Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases [ Time Frame: From enrollment to the end of the intervention up to 4 years. ]

Central Contacts

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