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| ID | Type | Description | Link |
|---|---|---|---|
| 24/228-P | Other Identifier | Ethical Committee for Research with Medicines (CEIm) IDIAP Jordi Gol |
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| Name | Class |
|---|---|
| IPSOS | INDUSTRY |
| Program on Substance Abuse, Public Health Agency, Government of Catalonia | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
- all the purchased alcohol containers are too small for a label sticker to be affixed
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| Name | Affiliation | Role |
|---|---|---|
| Daša Kokole, PhD | World Health Organisation Regional Office for Europe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sampled supermarkets in selected city neighbourhoods | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41565326 | Derived | 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. |
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All IPD that underlie results in a publication(s).
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.
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.
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Front label | Behavioral | A sticker will be applied to the front of the alcoholic beverage containers purchased by the participants. |
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| Back label | Behavioral | A sticker will be applied to the back of the alcoholic beverage containers purchased by the participants. |
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| Outcome pre-testing | Other | Primary outcome (knowledge of alcohol related harms) is tested at baseline. |
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| No outcome pre-testing | Other | Primary outcome (knowledge of alcohol related harms) is not tested at baseline. |
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| 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). | 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. | 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"). | 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). | 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). | 1 week |
| ID | Term |
|---|---|
| D000431 | Ethanol |
| D004348 | Drug Labeling |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D004349 | Drug Packaging |
| D004345 | Drug Industry |
| D066192 | Manufacturing Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D019064 | Product Packaging |
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