NCT06214416

Pragmatic Clinical Trial of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL

Pragmatic Clinical Trial to Compare the Short and Medium Term Effects of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

NAMETI-Alcohol, from the acronym for Navarra Medical Trialist Initiative, is a pilot study in which two patterns of alcohol consumption, abstention and Mediterranean alcohol-drinking pattern, and their effects on health in the short and medium term will be compared.

Detailed description

Background: Alcohol is the most consumed psychoactive substance in Spain. In 2016 it was the seventh leading risk factor for death and disability-adjusted lost years worldwide, and the first one in people between 15 and 49 years old.In the scientific community there is some controversy about what would be the best approach to face this great problem. On the one hand, there is evidence to recommend that there is no safe level of alcohol. However, on the other hand, there are studies that demonstrate the protective role of a moderate alcohol consumption. In this pilot study both options will be compared. Methods: It is intended to recruit a total of 100 participants, including two observational cohorts of abstainers and drinkers. The intervention will be carried out in drinkers willing to change their alcohol consumption, divided into 2 groups of 50 participants, the abstention group and the Mediterranean alcohol-drinking pattern group. The Mediterranean alcohol-drinking pattern includes 5 aspects: moderate alcohol consumption (maximum of 1 drinks/day for women and 2 drinks/day for men), spread consumption throughout the week, drink with meals and never with an empty stomach, prefer wine and mainly red wine, as well as completely avoid episodes of binge-drinking. The main objective will be to compare the short and medium term effects on health of both patterns.

Conditions

• Alcohol Drinking

Interventions

Type	Name	Description
BEHAVIORAL	Abstention	All the intervention will be carried out online once a month for a year, focusing on nutritional, behavioral and scientific evidence aspects, that promote abstention.
BEHAVIORAL	Mediterranean alcohol-drinking pattern	All the intervention will be carried out online once a month for a year, focusing on nutritional, behavioral and scientific evidence aspects, that promote the Mediterranean alcohol-drinking pattern.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: Spain