Impact of Alcohol Labels in a Real-World Setting

World Health Organization (WHO)

Status: Enrolling

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

Treatments: Behavioral: Front label; Other: No outcome pre-testing; Behavioral: Back label; Behavioral: Alcohol health warning label - cancer; Behavioral: Responsibility message on alcohol label; Other: Outcome pre-testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06915298

24/228-P (Other Identifier)

ERC.0004213

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 8 patient groups

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

Active Comparator group

Description:

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.

Treatment:

Behavioral: Responsibility message on alcohol label

Other: No outcome pre-testing

Behavioral: Front label

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

Active Comparator group

Description:

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.

Treatment:

Behavioral: Responsibility message on alcohol label

Behavioral: Back label

Other: No outcome pre-testing

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

Experimental group

Description:

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.

Treatment:

Behavioral: Alcohol health warning label - cancer

Other: No outcome pre-testing

Behavioral: Front label

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

Experimental group

Description:

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.

Treatment:

Behavioral: Back label

Behavioral: Alcohol health warning label - cancer

Other: No outcome pre-testing

Responsibility message - front of the container / pre-test

Active Comparator group

Description:

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.

Treatment:

Other: Outcome pre-testing

Behavioral: Responsibility message on alcohol label

Behavioral: Front label

Responsibility message - back of the container / pre-test

Active Comparator group

Description:

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.

Treatment:

Other: Outcome pre-testing

Behavioral: Responsibility message on alcohol label

Behavioral: Back label

Cancer message - front of the container / pre-test

Experimental group

Description:

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.

Treatment:

Other: Outcome pre-testing

Behavioral: Alcohol health warning label - cancer

Behavioral: Front label

Cancer message - back of the container / pre-test

Experimental group

Description:

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.

Treatment:

Other: Outcome pre-testing

Behavioral: Back label

Behavioral: Alcohol health warning label - cancer