Risk PerceptionsNCT07812545
Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
A study testing Health warning statement evaluations (bottles) and Health warning statement evaluations (ads) in people with Risk Perceptions and Decision Making, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Risk Perceptions, Decision Making, Alcohol
- What is being tested?
- Health warning statement evaluations (bottles) and Health warning statement evaluations (ads)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Campus, Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
Zachary Massey, PhD, 405-271-6872, zachary-massey@ou.edu
About this study
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.
Read the 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.
- Conditions
- Risk Perceptions, Decision Making, Alcohol
- Being tested
- Health warning statement evaluations (bottles), Health warning statement evaluations (ads)
- Keywords
- Alcohol health warning statements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health warning statement evaluations (bottles)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health warning statement evaluations (ads) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed immediately after stimulus exposure.
Attitudes about alcohol consumption (questionnaire self-report)
Continuous self-report measure (1 to 7) for attitudes about alcohol consumption.
Measured: 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.
Measured: 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.
Measured: Assessed immediately after stimulus exposure.
Secondary outcomes (7)
Attention to warning statements (questionnaire self-report)
Continuous self-report measure (1 to 9) of attention to experimental images.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed immediately after stimulus exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start27 Jul 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk PerceptionsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812545
- Sponsor's protocol ID
- 18774
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
- ClinicalTrials.gov ID
- NCT07812545
- Acronym / sponsor ID
- 18774
- Conditions
- Risk Perceptions, Decision Making, Alcohol
- Keywords
- Alcohol health warning statements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health warning statement evaluations (bottles) | Experimental | Behavioral: 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. |
| Health warning statement evaluations (ads) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Health warning statement evaluations (bottles) |
| 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). | Behavioural | Health warning statement evaluations (ads) |
Primary outcome
Risk perceptions of alcohol harms (questionnaire self-report)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Attention to warning statements (questionnaire self-report)
Time frame: Assessed immediately after stimulus exposure.
Perceived message effectiveness (questionnaire self-report)
Time frame: Assessed immediately after stimulus exposure.
Reactance (questionnaire self-report)
Time frame: Assessed immediately after stimulus exposure.
Emotional responses (questionnaire self-report)
Time frame: Assessed immediately after stimulus exposure.
Alcohol product appeal (questionnaire self-report)
Time frame: Assessed immediately after stimulus exposure.
Unaided recall (i.e., correctly recalling health effects described in warnings)
Time frame: Assessed immediately after stimulus exposure.
"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)
Time frame: Assessed immediately after stimulus exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health warning statement evaluations (bottles) and Health warning statement evaluations (ads) in people with Risk Perceptions and Decision Making, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zachary Massey, PhD ((405) 271-6872, zachary-massey@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk perceptions of alcohol harms (questionnaire self-report) (time frame: Assessed immediately after stimulus exposure.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.