Behaviour ChangeNCT07116447
Impact of Alcohol Health Messages in a Real-world Online Retail Setting
A study testing Health messages - existing Swedish legislation and Health messages - pictograms in people with Behaviour Change and Knowledge, run by World Health Organization at 1 site in Sweden.
Trial summary
The goal of this between-participants parallel randomized controlled trial conducted in the Systembolaget mobile application is to investigate the impact of exposure to health messages on cognition and behaviour. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behaviour Change, Knowledge, Risk Perception
- What is being tested?
- Health messages - existing Swedish legislation and Health messages - pictograms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,719 participants
- Where
- 1 siteSweden
- Study dates
- 2 Sep 2025to 9 Dec 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum alcohol purchase age in Sweden (20+)
- have downloaded the Systembolaget app and have given permission to the app to track in-app analytics
- understand Swedish language
Who cannot join
- not of minimum alcohol purchase age in Sweden
- no permission to track in-app analytics
- no understanding of Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Repeated Exposure to Alcohol Health Warning Messages in a Real-world Online Retail Setting: Protocol For a Randomised Controlled Trial in Systembolaget App
The goal of this between-participants parallel randomized controlled trial conducted in the Systembolaget mobile application is to investigate the impact of exposure to health messages on cognition and behaviour.
The primary study objective is to examine whether repeated exposure to rotating health warning messages in a mobile app where customers can purchase alcoholic beverages influences the number of purchased units of alcohol over the studied period.
Read more
The secondary objectives are to examine whether repeated exposure to health warning messages in a mobile app influences the number of alcoholic and non-alcoholic products purchased over the studied period, knowledge of alcohol-related harms, alcohol-related risk perceptions, emotional response to the message, engagement with the messages, behavioural intentions and self-reported behaviour of the study participants.
Users of the app providing informed consent for participation in the study will be assigned either to an experimental group, where they will be exposed to rotating messages describing health risks associated with alcohol designed in line with the existing Swedish regulation, or to a control group that will be exposed to messages reflecting existing industry practice.
The intervention will last for ten weeks, during which the recruited participants' data on product purchases in the app will be collected through in-app analytics. Both the number of alcoholic units and number of products purchased per session will be assessed and compared at the session level between the two groups. At the end of the intervention, participants will complete a short survey examining their knowledge, risk perceptions, emotional response, engagement with the messages, intentions and behaviour.
- Conditions
- Behaviour Change, Knowledge, Risk Perception, Emotional Response, Message Perception, Intentions
- Being tested
- Health messages - existing Swedish legislation, Health messages - pictograms
- Keywords
- alcohol, health warning, online supermarket, point-of-sale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health messages - existing Swedish legislationBehavioural
Textual health warning messages currently mandated for use in printed alcohol advertisements under the Swedish Alcohol Ordinance, focusing on communicated various alcohol harms
Health messages - pictogramsBehavioural
Pictograms indicating no alcohol use during pregnancy and while driving
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group will be exposed to textual health warning messages currently mandated for use in printed alcohol advertisements under the Swedish Alcohol Ordinance (1994:2046). Messages will rotate, with each user exposed to a single message per session. The following eight messages will be included:
Alcohol is addictive. Alcohol can cause damage to nerves and the brain. Alcohol can cause damage to the liver and pancreas. Alcohol can cause cerebral haemorrhage and cancer. Half of drivers who die in road traffic accidents involving just one vehicle are under the influence of alcohol.
Half of all people who drown have alcohol in their blood. Alcohol consumption during pregnancy can damage the child. Children who are given alcohol at home drink to intoxication more frequently than other children. Receives: Behavioral: Health messages - existing Swedish legislation |
| Control | Active comparator | The control group will consistently be exposed to health messages that are commonly present on existing alcohol labels and are aligned with voluntary commitments of alcohol producers, such as pictograms indicating no alcohol use during pregnancy and while driving. These pictograms will be displayed in black and white and in small sizes consistent with current practice, with a diameter of approximately 6 millimetres. Receives: Behavioral: Health messages - pictograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of purchased units of alcohol
Alcohol units will be calculated based on product-specific information on alcohol by volume (ABV) and volume purchased. The calculations will be made for the overall purchases and separately by type of beverage (beer, wine, spirits, other).
Measured: From enrolment to the end of the intervention period at 10 weeks
Secondary outcomes (7)
Number of individual purchased products
For overall purchases and separately by type of beverage (beer, wine, spirits, other, non-alcoholic beverages)
Measured: From enrolment to the end of the intervention period at 10 weeks.
Knowledge of alcohol-related harms
Will be assessed with 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 , Liver Disease, Respiratory Disease, Alcohol use disorder, Injuries, Diabetes, Pancreatitis, Multiple sclerosis, Cerebral haemorrhage, Fetal alcohol spectrum disorder] displayed randomly, and "I don't know" and "None" as exclusive options. The question format and options were adapted from a previous study [18], but expanded with a longer list of possible outcomes described in the used health messages. Two outcomes will be derived from this question: (i) the correct identification of the conditions mentioned in the messages, with the possible score range being between 0 and 7 points, and (ii) the correct identification of cancer as condition that alcohol increases risk of.
Measured: End of 10 week intervention period
Self-reported behaviour
Alcohol consumption behaviour will be based on question on whether they have foregone an alcoholic drink because they wanted to drink less and whether they have ever replaced alcoholic beverage with a non-alcoholic alternative because they wanted to drink less alcohol.
Measured: End of 10 week intervention period
Risk perception
Perceived personal cancer risk will be measured with the 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 the 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: End of 10 week intervention period
Intention
Intention will be measured with the question "I intend to cut down on the number of alcohol units that I drink in the next month" on 5-point Likert scale (Strongly Disagree to Strongly Agree).
Measured: End of 10 week intervention period
Emotional response
Emotional response will only be measured among those reporting to have noticed the warnings, "Thinking about messages 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: End of 10 week intervention period
Engagement with messages
- Noticing, reading and recalling the warnings: Participants will be asked if they noticed health-related messages while using the Systembolaget app in the past two months. Participants will also be presented with a list of statements and asked to mark which of those have they been exposed to during participation in the study.
- Information seeking behaviour: If participants noticed the health messages, they will be asked if they took any actions such as searching for more information about health risks, discussing the information with others, or looking for ways to reduce their alcohol consumption.
- Message perceptions: Participants who noticed the health messages will also be asked to indicate their level of agreement with statements about the impact of the information on their alcohol consumption, purchasing behaviour, and their perception of the information's acceptability, novelty, relevance, and believability. Responses will be measured on a 5-point Likert scale.
Measured: End of 10 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Sep 2025
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behaviour ChangeStudies 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
- 11,719 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Systembolaget
- Responsible party
- Principal investigator, Daša Kokole, World Health Organization
- Investigators
- Dasa Kokole, PhD, Principal investigator, World Health Organisation Regional Office for Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116447
- Sponsor's protocol ID
- 2025-03328-01
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2025
- Last updated
- 18 Dec 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 publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Repeated Exposure to Alcohol Health Warning Messages in a Real-world Online Retail Setting: Protocol For a Randomised Controlled Trial in Systembolaget App
- ClinicalTrials.gov ID
- NCT07116447
- Acronym / sponsor ID
- 2025-03328-01
- Conditions
- Behaviour Change, Knowledge, Risk Perception, Emotional Response, Message Perception, Intentions
- Keywords
- alcohol, health warning, online supermarket, point-of-sale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,719 participants (actual)
- Lead sponsor
- World Health OrganizationUniversity, hospital or other
- Collaborators
- Systembolaget
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 11 Aug 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.
The goal of this between-participants parallel randomized controlled trial conducted in the Systembolaget mobile application is to investigate the impact of exposure to health messages on cognition and behaviour.
The primary study objective is to examine whether repeated exposure to rotating health warning messages in a mobile app where customers can purchase alcoholic beverages influences the number of purchased units of alcohol over the studied period.
The secondary objectives are to examine whether repeated exposure to health warning messages in a mobile app influences the number of alcoholic and non-alcoholic products purchased over the studied period, knowledge of alcohol-related harms, alcohol-related risk perceptions, emotional response to the message, engagement with the messages, behavioural intentions and self-reported behaviour of the study participants.
Users of the app providing informed consent for participation in the study will be assigned either to an experimental group, where they will be exposed to rotating messages describing health risks associated with alcohol designed in line with the existing Swedish regulation, or to a control group that will be exposed to messages reflecting existing industry practice.
The intervention will last for ten weeks, during which the recruited participants' data on product purchases in the app will be collected through in-app analytics. Both the number of alcoholic units and number of products purchased per session will be assessed and compared at the session level between the two groups. At the end of the intervention, participants will complete a short survey examining their knowledge, risk perceptions, emotional response, engagement with the messages, intentions and behaviour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health messages - existing Swedish legislationParticipants in the intervention group will be exposed to textual health warning messages currently mandated for use in printed alcohol advertisements under the Swedish Alcohol Ordinance (1994:2046). Messages will rotate, with each user exposed to a single message per session. The following eight messages will be included: Alcohol is addictive. Alcohol can cause damage to nerves and the brain. Alcohol can cause damage to the liver and pancreas. Alcohol can cause cerebral haemorrhage and cancer. Half of drivers who die in road traffic accidents involving just one vehicle are under the influence of alcohol. Half of all people who drown have alcohol in their blood. Alcohol consumption during pregnancy can damage the child. Children who are given alcohol at home drink to intoxication more frequently than other children. |
| Control | Active comparator | Behavioral: Health messages - pictogramsThe control group will consistently be exposed to health messages that are commonly present on existing alcohol labels and are aligned with voluntary commitments of alcohol producers, such as pictograms indicating no alcohol use during pregnancy and while driving. These pictograms will be displayed in black and white and in small sizes consistent with current practice, with a diameter of approximately 6 millimetres. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- minimum alcohol purchase age in Sweden (20+)
- have downloaded the Systembolaget app and have given permission to the app to track in-app analytics
- understand Swedish language
Key exclusion criteria (3 listed)
- not of minimum alcohol purchase age in Sweden
- no permission to track in-app analytics
- no understanding of Swedish language
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 |
|---|---|---|
| Health messages - existing Swedish legislationTextual health warning messages currently mandated for use in printed alcohol advertisements under the Swedish Alcohol Ordinance, focusing on communicated various alcohol harms | Behavioural | Intervention |
| Health messages - pictogramsPictograms indicating no alcohol use during pregnancy and while driving | Behavioural | Control |
Primary outcome
Number of purchased units of alcohol
Time frame: From enrolment to the end of the intervention period at 10 weeks
Alcohol units will be calculated based on product-specific information on alcohol by volume (ABV) and volume purchased. The calculations will be made for the overall purchases and separately by type of beverage (beer, wine, spirits, other).
7 secondary outcomes
Number of individual purchased products
Time frame: From enrolment to the end of the intervention period at 10 weeks.
Knowledge of alcohol-related harms
Time frame: End of 10 week intervention period
Self-reported behaviour
Time frame: End of 10 week intervention period
Risk perception
Time frame: End of 10 week intervention period
Intention
Time frame: End of 10 week intervention period
Emotional response
Time frame: End of 10 week intervention period
Engagement with messages
Time frame: End of 10 week intervention period
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 18 Dec 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publications.
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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.
Dasa 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?
A study testing Health messages - existing Swedish legislation and Health messages - pictograms in people with Behaviour Change and Knowledge, run by World Health Organization at 1 site in Sweden.
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 3 inclusion and 3 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 18 Dec 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 Sweden. 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?
Number of purchased units of alcohol (time frame: From enrolment to the end of the intervention period at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.