Impact of Alcohol Labels in a Real-World Setting

NCT06915298 | Completed

• 2 other identifiers: ERC.000421324/228-P
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to evaluate the impact of health information labeling on alcohol-related knowledge and behaviors in adults purchasing alcohol in Barcelona, Spain. The main questions it aims to answer are:

• Does a label containing a cancer message have a larger impact on knowledge, behavior, intentions, risk perception, emotional response, product appeal and policy support compared to a responsibility label?
• Does the positioning of the label (front vs. back) on the alcohol container affect these outcomes? Researchers will compare the impact of cancer message labels vs. responsibility labels and front vs. back positioning to see if there are differences in the primary outcome (knowledge of alcohol causing cancer) and secondary outcomes (behavior, intentions, risk perception, emotional response, and policy support). Additionally, the study will provide insight in whether there is a testing effect of primary outcome pre-measurement by exposing only half of the sample to baseline question on knowledge of alcohol related harms. Participants will:
• Be recruited in front of selected supermarkets in Barcelona after purchasing alcohol for their own consumption.
• Complete a baseline questionnaire.
• Receive a sticker containing a randomly assigned health message that will be applied to every alcohol beverage they have purchased.
• Receive an invitation to complete two follow-up surveys, one a week and one a month after the intervention.

Conditions

Knowledge; Behaviour Change; Risk Perception; Intention; Support for Alcohol Policies; Emotional Response; Product Appeal

Keywords

alcohol; health warning label; supermarket

Outcome Measures

Primary Outcomes (1)

• Knowledge of alcohol causing cancer

  Knowledge will be assessed with the question "Which of the following diseases and conditions does alcohol consumption increase the risk of? (select all that apply)", with the possible choices being "Cancer", "Heart disease", "Respiratory disease", "Alcohol Use Disorder", "Injuries", "Diabetes" and "Liver disease" displayed randomly, and "I don't know" and "None" as exclusive options. If participants select "Cancer" as an outcome, a follow up question will ask: "Which of the following cancers do you think drinking alcohol increases the risk of? (select all that apply)", with "Female breast cancer", "Liver cancer", "Colon cancer", "Skin cancer", "Oral cancer", displayed randomly, and "I don't know" and "None" as exclusive options. The outcome will be dichotomous based on whether the participants correctly identify the link between alcohol and two cancers mentioned in the label: breast and colon cancer.

  1 week / 1 month

Secondary Outcomes (6)

• Alcohol consumption behaviour

  1 week / 1 month

• Risk perception

  1 week / 1 month

• Behavioural intention

  1 week / 1 month

• Emotional response to the labels

  1 week

• Support for alcohol policies

  1 week / 1 month

Study Arms (8)

Responsibility message - front of the container / no pre-test

ACTIVE COMPARATOR

A sticker with a message to drink responsibly is applied to the front of the container. There is no question on knowledge of alcohol related harms at baseline.

Behavioral: Responsibility message on alcohol label; Behavioral: Front label; Other: No outcome pre-testing

Responsibility message - back of the container / no pre-test

ACTIVE COMPARATOR

A sticker with a message to drink responsibly is applied to the back of the container. There is no question on knowledge of alcohol related harms at baseline.

Behavioral: Responsibility message on alcohol label; Behavioral: Back label; Other: No outcome pre-testing

Cancer message - front of the container / no pre-test

EXPERIMENTAL

A sticker with a message on alcohol causing cancer is applied to the front of the container. There is no question on knowledge of alcohol related harms at baseline.

Behavioral: Alcohol health warning label - cancer; Behavioral: Front label; Other: No outcome pre-testing

Cancer message - back of the container / no pre-test

EXPERIMENTAL

A sticker with a message on alcohol causing cancer is applied to the back of the container. There is no question on knowledge of alcohol related harms at baseline.

Behavioral: Alcohol health warning label - cancer; Behavioral: Back label; Other: No outcome pre-testing

Responsibility message - front of the container / pre-test

ACTIVE COMPARATOR

A sticker with a message to drink responsibly is applied to the front of the container. There is a question on knowledge of alcohol related harms at baseline.

Behavioral: Responsibility message on alcohol label; Behavioral: Front label; Other: Outcome pre-testing

Responsibility message - back of the container / pre-test

ACTIVE COMPARATOR

A sticker with a message to drink responsibly is applied to the back of the container. There is a question on knowledge of alcohol related harms at baseline.

Behavioral: Responsibility message on alcohol label; Behavioral: Back label; Other: Outcome pre-testing

Cancer message - front of the container / pre-test

EXPERIMENTAL

A sticker with a message on alcohol causing cancer is applied to the front of the container. There is a question on knowledge of alcohol related harms at baseline.

Behavioral: Alcohol health warning label - cancer; Behavioral: Front label; Other: Outcome pre-testing

Cancer message - back of the container / pre-test

EXPERIMENTAL

A sticker with a message on alcohol causing cancer is applied to the back of the container. There is a question on knowledge of alcohol related harms at baseline.

Behavioral: Alcohol health warning label - cancer; Behavioral: Back label; Other: Outcome pre-testing

Interventions

Alcohol health warning label - cancer BEHAVIORAL

A sticker with health information on alcohol causing cancer is applied to alcoholic beverage containers purchased by the participants.

Cancer message - back of the container / no pre-test; Cancer message - back of the container / pre-test; Cancer message - front of the container / no pre-test; Cancer message - front of the container / pre-test

Responsibility message on alcohol label BEHAVIORAL

A sticker with a message to drink responsibly will be applied to alcoholic beverage containers purchased by the participants.

Responsibility message - back of the container / no pre-test; Responsibility message - back of the container / pre-test; Responsibility message - front of the container / no pre-test; Responsibility message - front of the container / pre-test

Front label BEHAVIORAL

A sticker will be applied to the front of the alcoholic beverage containers purchased by the participants.

Cancer message - front of the container / no pre-test; Cancer message - front of the container / pre-test; Responsibility message - front of the container / no pre-test; Responsibility message - front of the container / pre-test

Back label BEHAVIORAL

A sticker will be applied to the back of the alcoholic beverage containers purchased by the participants.

Cancer message - back of the container / no pre-test; Cancer message - back of the container / pre-test; Responsibility message - back of the container / no pre-test; Responsibility message - back of the container / pre-test

Outcome pre-testing OTHER

Primary outcome (knowledge of alcohol related harms) is tested at baseline.

Cancer message - back of the container / pre-test; Cancer message - front of the container / pre-test; Responsibility message - back of the container / pre-test; Responsibility message - front of the container / pre-test

No outcome pre-testing OTHER

Primary outcome (knowledge of alcohol related harms) is not tested at baseline.

Cancer message - back of the container / no pre-test; Cancer message - front of the container / no pre-test; Responsibility message - back of the container / no pre-test; Responsibility message - front of the container / no pre-test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have just purchased at least one alcoholic beverage container for their own consumption
• speak Spanish or Catalan
• are 18 years or older
• provide informed consent to participation

You may not qualify if:

• \- all the purchased alcohol containers are too small for a label sticker to be affixed

Sponsors & Collaborators

• World Health Organization: lead
• IPSOS: collaborator
• Program on Substance Abuse, Public Health Agency, Government of Catalonia: collaborator

Study Sites (1)

Sampled supermarkets in selected city neighbourhoods

Barcelona, Spain

Location

Related Publications (1)

• Kokole D, Neufeld M, Correia D, Rehm J, Ferreira-Borges C, Hobin E, Rovira P, Segura Garcia L, Colom Farran J. Impacts of alcohol health warning labels in a real-world setting: protocol for a randomised controlled trial among supermarket customers in Barcelona. BMJ Open. 2026 Jan 21;16(1):e103464. doi: 10.1136/bmjopen-2025-103464.

  PMID: 41565326 DERIVED

MeSH Terms

Interventions

Ethanol; Drug Labeling

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Technology, Pharmaceutical; Investigative Techniques; Drug Packaging; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Study Officials

• Daša Kokole, PhD

  World Health Organisation Regional Office for Europe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 23, 2025
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The dataset will be available following the open data sharing practices, and will be available on Figshare repository (https://figshare.com/) once the article with the main results is published.
• Access Criteria: The interested researchers will be able to access and download the data directly through the platform, without requiring any permissions. The article, including the dataset will be shared under a noncommercial license (e.g. Creative Commons Attribution-NonCommercial (CC BY-NC)), allowing others to use the data for research, educational, or other noncommercial purposes, but not for commercial advantage or monetary gain.

Locations

ES (1)