Clinical trial NCT06915298: Impact of Alcohol Labels in a Real-World Setting
Official title: Impact of Providing Health Information on Alcohol Labels in a Real-World Setting: a Randomized Controlled Trial Among Supermarket Customers in Barcelona
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knowledge
Behaviour Change
Risk Perception
Intention
Support for Alcohol Policies
Emotional Response
Product Appeal
Keywords: alcohol
health warning label
supermarket
Lead sponsor: World Health Organization
Sponsor class: OTHER
Collaborators: name: IPSOS
name: Program on Substance Abuse, Public Health Agency, Government of Catalonia
First posted: 2025-04-08
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of alcohol causing cancer
timeFrame: 1 week / 1 month
Secondary outcomes:
measure: Alcohol consumption behaviour
timeFrame: 1 week / 1 month
measure: Risk perception
timeFrame: 1 week / 1 month
measure: Behavioural intention
timeFrame: 1 week / 1 month
measure: Emotional response to the labels
timeFrame: 1 week
measure: Support for alcohol policies
timeFrame: 1 week / 1 month
measure: Product appeal
timeFrame: 1 week
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sampled supermarkets in selected city neighbourhoods
Study officials:
affiliation: World Health Organisation Regional Office for Europe
name: Daša Kokole, PhD
role: PRINCIPAL_INVESTIGATOR
References: