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Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.

Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07812545
Enrollment
2000
Registered
2026-09-10
Start date
2026-07-27
Completion date
2026-09-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol, Decision Making, Risk Perceptions

Keywords

Alcohol health warning statements

Brief summary

Consuming alcohol is a dose-dependent and modifiable risk factor for breast cancer. Although alcohol consumption contributes to an estimated 16% of breast cancer cases, awareness of the link between alcohol and breast cancer risk remains low. Systematically developed and tested health warnings can support population-based approaches and intervention strategies to decrease alcohol consumption and breast cancer risk. For instance, the U.S. Food and Drug Administration can mandate specific warnings through statements (e.g., "WARNING: This product contains nicotine…") and color graphics depicting the negative health consequences of products that can harm public health, such as tobacco and alcohol. However, health warning statements and graphics should be assessed among intended audiences before implementation. Research has outlined principles for effective health warning statements. This project will test different health warning statements about the health effects of alcohol.

Detailed description

Health warning statements should be assessed for effectiveness among target audiences before implementation as interventions. Research has outlined principles for effective health warning statements. Specifically, health warning statements are effective when they impact mediators of health behavior (e.g., message perceptions, emotional/affective reactions, and resistance to messages) as well as actual behavior. Guided by these assumptions, we will conduct an online randomized clinical trial (RCT) (N=2,000) with US female participants (ages 18 to 65 years) who report consuming alcohol in the past 30 days (i.e., people who currently drink) and young adult female non-drinkers (ages 18-29) to assess how both samples rate different alcohol health warning statements presented in different formats.

Interventions

BEHAVIORALHealth warning statement evaluations (bottles)

The experiment will use a 2 (health warning statement: single-theme statement vs. composite paragraph) x 2 (pictogram: present vs. absent) x 2 (format: alcohol container vs. alcohol advertisement) between- and within-subjects design. The between-subject groups are 2 (health warning statement: single-theme vs. composite message) x 2 (pictogram: present vs. absent), and the within-subjects factor is the format of warning presentation (2 alcohol containers vs. 2 alcohol advertisements).

BEHAVIORALHealth warning statement evaluations (ads)

The experiment will use a 2 (health warning statement: single-theme statement vs. composite paragraph) x 2 (pictogram: present vs. absent) x 2 (format: alcohol container vs. alcohol advertisement) between- and within-subjects design. The between-subject groups are 2 (health warning statement: single-theme vs. composite message) x 2 (pictogram: present vs. absent), and the within-subjects factor is the format of warning presentation (2 alcohol containers vs. 2 alcohol advertisements).

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* being between 18 and 65 years of age * assigned female at birth * self-report having consumed alcohol in the last 30 days for the current drinker groups * self-report not having consumed alcohol in the last 30 days for the nondrinker groups * live in the US and able to read, speak, and understand English

Design outcomes

Primary

MeasureTime frameDescription
Risk perceptions of alcohol harms (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) for perceptions of severity and likelihood of negative health effects occurring as a result of alcohol consumption.
Perceived efficacy to prevent alcohol harms (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) for perceptions of response and self-efficacy to protect against the negative health effects occurring as a result of alcohol consumption.
Attitudes about alcohol consumption (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 7) for attitudes about alcohol consumption.
Intentions to quit or reduce drinking alcohol (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) for intentions to quit or reduce alcohol consumption in the next 6 months.
Intentions to seek information about alcohol health effects and cancer screenings (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) for intentions to seek information about the health effects of alcohol, including cancer screenings.

Secondary

MeasureTime frameDescription
Attention to warning statements (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) of attention to experimental images.
Perceived message effectiveness (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.
Reactance (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) of opposition to the health warning information in experimental images.
Emotional responses (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) for strength of positive to negative feeling/emotions about the experimental images.
Alcohol product appeal (questionnaire self-report)Assessed immediately after stimulus exposure.Continuous self-report measure (1 to 9) for appeal of products in experimental images.
Unaided recall (i.e., correctly recalling health effects described in warnings)Assessed immediately after stimulus exposure.Open-ended qualitative recall. Participants are prompted to describe the health risks of alcohol use mentioned in the experimental images.
"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)Assessed immediately after stimulus exposure.Participants view the 1st image they were exposed to in the experiment with the health warning blurred and are prompted to write down everything they can recall about it.

Countries

United States

Contacts

CONTACTZachary Massey, PhD
zachary-massey@ou.edu(405) 271-6872

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026