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Age: 50Years - 75Years
All Genders
Healthy Volunteers
ID06338215

Comparing Moderate Drinking Advice to Abstention Advice for Adults 50 to 75 Years to Prevent Major Diseases and Death

Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2024-12-12

10000

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two different advice approaches on alcohol drinking in more than 10,000 Spanish adult drinkers aged 50 or older for men and 55 or older for women. The study aims to compare whether following a moderate alcohol drinking pattern, specifically the Mediterranean Alcohol Drinking Pattern MADP, is not worse than abstaining from alcohol in preventing all-cause mortality and other chronic diseases such as cardiovascular disease, cancer, type 2 diabetes, depression, dementia, and infections. This large, randomized trial addresses the ongoing debate about alcohol consumption and health risks in older adults. Participants will be randomly assigned to one of two groups for four years. One group will receive advice to follow the MADP, which includes moderate alcohol consumption 7 or fewer drinks per week for women and 14 or fewer for men, avoiding binge drinking, preferring red wine consumed with meals, and spreading intake throughout the week. The other group will receive advice to abstain from alcohol. Both groups will receive support through quarterly remote sessions with specialized coaches, including psychologists and dietitians, involving small group meetings, personal interviews, and educational videos. During the study, participants will have four contacts per year for up to four years to receive their assigned advice and support. Researchers will monitor the incidence of a combined index of health outcomes including mortality, cardiovascular events, invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, serious injuries, and infections requiring hospitalization. Safety and adherence will be tracked through these regular contacts and assessments. The studys main measurement is the comparison of these health outcomes between the two groups over the intervention period.

CONDITIONS

Brief Title

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

Research Team

M

Miguel A Martinez-Gonzalez, MD, MPH, PhD

M

Maira Bes-Rastrollo, PharmD, PhD

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