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

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.

Study Overview

• Status: Recruiting
• Conditions: Decision Making; Alcohol; Risk Perceptions
• Intervention / Treatment: Behavioral: Health warning statement evaluations (bottles); Behavioral: Health warning statement evaluations (ads)

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zachary Massey, PhD; Phone Number: (405) 271-6872; Email: zachary-massey@ou.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Campus, Health Promotion Research Center
      • Contact: Zachary Massey, PhD; Phone Number: 405-271-6872; Email: zachary-massey@ou.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health warning statement evaluations (bottles); A randomized clinical trial (RCT) cohort of adult participants (18-65) will complete a computer-based survey-experiment during a single study visit (conducted online). They will review a series of hypothetical alcohol products and rate the images.	Behavioral: Health 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).
Experimental: Health warning statement evaluations (ads); A randomized clinical trial (RCT) cohort of adult participants (18-65) will complete a computer-based survey-experiment during a single study visit (conducted online). They will review a series of hypothetical alcohol products and rate the images.	Behavioral: Health 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention to warning statements (questionnaire self-report)	Continuous self-report measure (1 to 9) of attention to experimental images.	Assessed immediately after stimulus exposure.
Perceived message effectiveness (questionnaire self-report)	Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.	Assessed immediately after stimulus exposure.
Reactance (questionnaire self-report)	Continuous self-report measure (1 to 9) of opposition to the health warning information in experimental images.	Assessed immediately after stimulus exposure.
Emotional responses (questionnaire self-report)	Continuous self-report measure (1 to 9) for strength of positive to negative feeling/emotions about the experimental images.	Assessed immediately after stimulus exposure.
Alcohol product appeal (questionnaire self-report)	Continuous self-report measure (1 to 9) for appeal of products in experimental images.	Assessed immediately after stimulus exposure.
Unaided recall (i.e., correctly recalling health effects described in warnings)	Open-ended qualitative recall. Participants are prompted to describe the health risks of alcohol use mentioned in the experimental images.	Assessed immediately after stimulus exposure.
"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)	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.	Assessed immediately after stimulus exposure.

Collaborators and Investigators

• Sponsor: University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Alcohol health warning statements
• Other Study ID Numbers: 18774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No