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

University of Navarra

Status: Completed

Conditions: Alcohol Drinking

Treatments: Behavioral: Mediterranean alcohol-drinking pattern; Behavioral: Abstention

Study type: Interventional

Funder types: Other

Identifiers

NCT06214416

NAMETI_ALCOHOL_10_2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Consuming more than 3 drinks a week (except for the abstention-control arm)

Exclusion criteria

• Sever chronic disease (cancer, cardiovascular disease, chronic hepatitis and mental illness)
• Pregnant women or breastfeeding
• Family or personal history of addiction, alcoholism or alcohol abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 4 patient groups

Abstention

Active Comparator group

Description:

These participants will be encouraged to totally avoid alcohol consumption.

Treatment:

Behavioral: Abstention

Mediterranean alcohol-drinking pattern

Active Comparator group

Description:

These participants will be encouraged to change their pattern of consumption to a more Mediterranean way, which includes 5 aspects: moderate alcohol consumption (maximum of 2 drinks/day for women and 4 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.

Treatment:

Behavioral: Mediterranean alcohol-drinking pattern

Control of abstainers

No Intervention group

Description:

This group will include all participants who consume less than 3 alcohol drinks a week at the time of recruitment.

Control of drinkers

No Intervention group

Description:

This group will include all participants who don't want to change their alcohol-drinking pattern.