NCT07116447

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,719

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

August 6, 2025

Last Update Submit

December 10, 2025

Conditions

Keywords

alcoholhealth warningonline supermarketpoint-of-sale

Outcome Measures

Primary Outcomes (1)

  • 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).

    From enrolment to the end of the intervention period at 10 weeks

Secondary Outcomes (7)

  • Number of individual purchased products

    From enrolment to the end of the intervention period at 10 weeks.

  • Knowledge of alcohol-related harms

    End of 10 week intervention period

  • Self-reported behaviour

    End of 10 week intervention period

  • Risk perception

    End of 10 week intervention period

  • Intention

    End of 10 week intervention period

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Health messages - pictograms

Interventions

Textual health warning messages currently mandated for use in printed alcohol advertisements under the Swedish Alcohol Ordinance, focusing on communicated various alcohol harms

Intervention

Pictograms indicating no alcohol use during pregnancy and while driving

Control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not of minimum alcohol purchase age in Sweden
  • no permission to track in-app analytics
  • no understanding of Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Systembolaget mobile app

Stockholm, Sweden

Location

Study Officials

  • Dasa Kokole, PhD

    World Health Organisation Regional Office for Europe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 11, 2025

Study Start

September 2, 2025

Primary Completion

December 9, 2025

Study Completion

December 9, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in publications.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The dataset will be available following the open data sharing practices, and will be uploaded on Figshare repository (https://figshare.com/) once the article with the main results is published.
Access Criteria
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.

Locations