KnowledgeNCT06915298

Impact of Alcohol Labels in a Real-World Setting

A study testing Alcohol health warning label - cancer, Responsibility message on alcohol label and Front label in people with Knowledge and Behaviour Change, run by World Health Organization at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Knowledge, Behaviour Change, Risk Perception
What is being tested?: Alcohol health warning label - cancer, Responsibility message on alcohol label and Front label
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,410 participants
Where: 1 siteSpain
Study dates: 23 Apr 2025to 25 Jul 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Sampled supermarkets in selected city neighbourhoods
Barcelona

Other trials in Spain

About this study

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

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
Being tested: Alcohol health warning label - cancer, Responsibility message on alcohol label, Front label, Back label, Outcome pre-testing
Keywords: alcohol, health warning label, supermarket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alcohol health warning label - cancerBehavioural
A sticker with health information on alcohol causing cancer is applied to alcoholic beverage containers purchased by the participants.
Responsibility message on alcohol labelBehavioural
A sticker with a message to drink responsibly will be applied to alcoholic beverage containers purchased by the participants.
Front labelBehavioural
A sticker will be applied to the front of the alcoholic beverage containers purchased by the participants.
Back labelBehavioural
A sticker will be applied to the back of the alcoholic beverage containers purchased by the participants.
Outcome pre-testingOther
Primary outcome (knowledge of alcohol related harms) is tested at baseline.
No outcome pre-testingOther
Primary outcome (knowledge of alcohol related harms) is not tested at baseline.

Study groups in NCT06915298
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Alcohol health warning label - cancer; Behavioral: Back label; Other: Outcome pre-testing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 week / 1 month

Secondary outcomes (6)

Alcohol consumption behaviour
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).
Measured: 1 week / 1 month
Risk perception
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).
Measured: 1 week / 1 month
Behavioural intention
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.
Measured: 1 week / 1 month
Emotional response to the labels
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").
Measured: 1 week
Support for alcohol policies
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).
Measured: 1 week / 1 month
Product appeal
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).
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 202525 Jul 2025

First posted8 Apr 2025
Study start23 Apr 2025
Primary completion25 Jul 2025
Study completion25 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for KnowledgeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,410 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06915298
Sponsor's protocol ID: ERC.0004213
Other IDs: 24/228-P
Status last verified: Jul 2025
First submitted: 1 Apr 2025
Last updated: 6 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results in a publication(s).

Publications

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.
PubMed 41565326

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Providing Health Information on Alcohol Labels in a Real-World Setting: a Randomized Controlled Trial Among Supermarket Customers in Barcelona
ClinicalTrials.gov ID: NCT06915298
Acronym / sponsor ID: ERC.0004213
Conditions: Knowledge, Behaviour Change, Risk Perception, Intention, Support for Alcohol Policies, Emotional Response
Keywords: alcohol, health warning label, supermarket
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,410 participants (actual)
Lead sponsor: World Health OrganizationUniversity, hospital or other
Collaborators: IPSOS, Program on Substance Abuse, Public Health Agency, Government of Catalonia
Study start: 23 Apr 2025 (actual)
Primary completion: 25 Jul 2025 (actual)
Study completion: 25 Jul 2025 (actual)
First posted: 8 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Responsibility message - front of the container / no pre-test	Active comparator	Behavioral: Responsibility message on alcohol label, Behavioral: Front label, Other: No outcome pre-testingA 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.
Responsibility message - back of the container / no pre-test	Active comparator	Behavioral: Responsibility message on alcohol label, Behavioral: Back label, Other: No outcome pre-testingA 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.
Cancer message - front of the container / no pre-test	Experimental	Behavioral: Alcohol health warning label - cancer, Behavioral: Front label, Other: No outcome pre-testingA 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.
Cancer message - back of the container / no pre-test	Experimental	Behavioral: Alcohol health warning label - cancer, Behavioral: Back label, Other: No outcome pre-testingA 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.
Responsibility message - front of the container / pre-test	Active comparator	Behavioral: Responsibility message on alcohol label, Behavioral: Front label, Other: Outcome pre-testingA 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.
Responsibility message - back of the container / pre-test	Active comparator	Behavioral: Responsibility message on alcohol label, Behavioral: Back label, Other: Outcome pre-testingA 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.
Cancer message - front of the container / pre-test	Experimental	Behavioral: Alcohol health warning label - cancer, Behavioral: Front label, Other: Outcome pre-testingA 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.
Cancer message - back of the container / pre-test	Experimental	Behavioral: Alcohol health warning label - cancer, Behavioral: Back label, Other: Outcome pre-testingA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alcohol health warning label - cancerA sticker with health information on alcohol causing cancer is applied to alcoholic beverage containers purchased by the participants.	Behavioural	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 labelA sticker with a message to drink responsibly will be applied to alcoholic beverage containers purchased by the participants.	Behavioural	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 labelA sticker will be applied to the front of the alcoholic beverage containers purchased by the participants.	Behavioural	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 labelA sticker will be applied to the back of the alcoholic beverage containers purchased by the participants.	Behavioural	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-testingPrimary outcome (knowledge of alcohol related harms) is tested at baseline.	Other	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-testingPrimary outcome (knowledge of alcohol related harms) is not tested at baseline.	Other	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

Primary outcome

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.

6 secondary outcomes

Alcohol consumption behaviour
Time frame: 1 week / 1 month
Risk perception
Time frame: 1 week / 1 month
Behavioural intention
Time frame: 1 week / 1 month
Emotional response to the labels
Time frame: 1 week
Support for alcohol policies
Time frame: 1 week / 1 month
Product appeal
Time frame: 1 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Derived from this study: PubMed 41565326Kokole 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.
Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication(s).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daša Kokole, PhD principal investigator

World Health Organisation Regional Office for Europe

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge of alcohol causing cancer (time frame: 1 week / 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06915298, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.