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

NCT07812545 | Recruiting

• 1 other identifier: 18774
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Perceptions; Decision Making; Alcohol

Keywords

Alcohol health warning statements

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Attention to warning statements (questionnaire self-report)

  Assessed immediately after stimulus exposure.

• Perceived message effectiveness (questionnaire self-report)

  Assessed immediately after stimulus exposure.

• Reactance (questionnaire self-report)

  Assessed immediately after stimulus exposure.

• Emotional responses (questionnaire self-report)

  Assessed immediately after stimulus exposure.

• Alcohol product appeal (questionnaire self-report)

  Assessed immediately after stimulus exposure.

Study Arms (2)

Health warning statement evaluations (bottles)

EXPERIMENTAL

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)

Health warning statement evaluations (ads)

EXPERIMENTAL

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)

Interventions

Health warning statement evaluations (bottles) BEHAVIORAL

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).

Health warning statement evaluations (bottles)

Health warning statement evaluations (ads) BEHAVIORAL

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).

Health warning statement evaluations (ads)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Campus, Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Central Study Contacts

Zachary Massey, PhD

CONTACT

(405) 271-6872; zachary-massey@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 10, 2026
• Study Start: July 27, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)