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Completed

NCT Number: NCT06915298

Impact of Alcohol Labels in a Real-World Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sampled supermarkets in selected city neighbourhoods

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Front label

Behavioral

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

Back label

Behavioral

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

Outcome pre-testing

Other

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

No outcome pre-testing

Other

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

Primary outcomes

  1. Knowledge of alcohol causing cancer

    Time frame: 1 week / 1 month

    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.

Secondary outcomes

  1. Alcohol consumption behaviour

    Time frame: 1 week / 1 month

    Decrease in alcohol consumption will be measured with measuring the amount of standard drinks consumed in the last 7 days ("How many standard drinks of alcohol did you drink over the last 7 days?"), as well as based on question on whether they have foregone an alcoholic drink because they wanted to drink less (In the last 7 days, did you ever forego an alcoholic drink because you wanted to drink less? Yes/No).

  2. Risk perception

    Time frame: 1 week / 1 month

    Perceived personal cancer risk will be measured with question "If I consume alcohol on a regular basis, I am at greater risk of getting cancer." Perceived general health risk will be measured with question "If I consume more alcohol, I am at greater risk for health harm". Both questions will be measured on 5-point Likert scale (strongly Disagree to Strongly Agree).

  3. Behavioural intention

    Time frame: 1 week / 1 month

    Behavioural intention to decrease alcohol consumption will be measured with the question "I intend to cut down on the number of alcohol units that I drink in the forthcoming month" on 5-point Likert scale (Strongly Disagree to Strongly Agree), only at both follow-ups.

  4. Emotional response to the labels

    Time frame: 1 week

    Emotional response to the labels will only be measured among those reporting to have noticed the labels: "Thinking about the labels on the alcohol containers I've seen as part of this study, I felt: disgusted / afraid / uncomfortable / worried" / excited / pleased" With Likert answers scale from 1 to 5 (1 = "not at all", 3 = "moderately", and 5 = "very").

  5. Support for alcohol policies

    Time frame: 1 week / 1 month

    Support for alcohol policies will be measured with listing range of alcohol policies (e.g. increasing the price of alcohol, reducing the number of outlets that sell alcohol" and asking the participants "To what extent would you support the government in your country introducing the following alcohol-related policies? Please indicate your answer on the scale below from 1 (strongly disagree) to 5 (strongly agree).

  6. Product appeal

    Time frame: 1 week

    It will only be measured among those reporting to have noticed the labels, with three items developed for this study ("I found the beverages less appealing after noticing the health information on the labels"; "The health information on the labels reduced my enjoyment of these beverages"; "I felt the health information on the label detracted from the overall alcohol product appearance") on 5-point Likert scale (Strongly Disagree to Strongly Agree).

Sponsors and collaborators

Lead sponsor

World Health Organization

Other

Collaborators

  • IPSOS
  • Program on Substance Abuse, Public Health Agency, Government of Catalonia

Registry information

Official study title

Impact of Providing Health Information on Alcohol Labels in a Real-World Setting: a Randomized Controlled Trial Among Supermarket Customers in Barcelona

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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