Pragmatic Clinical Trial of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL
NCT ID: NCT06214416
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-11-01
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Abstention
These participants will be encouraged to totally avoid alcohol consumption.
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.
Mediterranean alcohol-drinking pattern
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.
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.
Control of abstainers
This group will include all participants who consume less than 3 alcohol drinks a week at the time of recruitment.
No interventions assigned to this group
Control of drinkers
This group will include all participants who don't want to change their alcohol-drinking pattern.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women or breastfeeding
* Family or personal history of addiction, alcoholism or alcohol abuse
18 Years
ALL
Yes
Sponsors
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Ministry of Health, Spain
OTHER_GOV
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Maira Bes Rastrollo
Professor
Locations
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University of Navarra
Pamplona, Navarre, Spain
Countries
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Other Identifiers
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NAMETI_ALCOHOL_10_2020
Identifier Type: -
Identifier Source: org_study_id
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