Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
Health warning statement evaluations (bottles)
BehavioralThe 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)
BehavioralThe 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).
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Health warning statement evaluations (bottles)Experimental treatment 1 intervention
Group B: Health warning statement evaluations (ads)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed immediately after stimulus exposure.2
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.
Time frame
Assessed immediately after stimulus exposure.3
Attitudes about alcohol consumption (questionnaire self-report)
Continuous self-report measure (1 to 7) for attitudes about alcohol consumption.
Time frame
Assessed immediately after stimulus exposure.4
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.
Time frame
Assessed immediately after stimulus exposure.Secondary outcomes
1
Attention to warning statements (questionnaire self-report)
Continuous self-report measure (1 to 9) of attention to experimental images.
Time frame
Assessed immediately after stimulus exposure.2
Perceived message effectiveness (questionnaire self-report)
Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.
Time frame
Assessed immediately after stimulus exposure.3
Reactance (questionnaire self-report)
Continuous self-report measure (1 to 9) of opposition to the health warning information in experimental images.
Time frame
Assessed immediately after stimulus exposure.4
Emotional responses (questionnaire self-report)
Continuous self-report measure (1 to 9) for strength of positive to negative feeling/emotions about the experimental images.
Time frame
Assessed immediately after stimulus exposure.Sponsors and contacts
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Source ClinicalTrials.gov