Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
8 september 2026 uppdaterad av: University of Oklahoma
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
2000
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zachary Massey, PhD
- Telefonnummer: (405) 271-6872
- E-post: zachary-massey@ou.edu
Studieorter
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- Rekrytering
- University of Oklahoma Health Campus, Health Promotion Research Center
-
Kontakt:
- Zachary Massey, PhD
- Telefonnummer: 405-271-6872
- E-post: zachary-massey@ou.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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).
|
|
Experimentell: 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.
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Risk perceptions of alcohol harms (questionnaire self-report)
Tidsram: 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.
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Assessed immediately after stimulus exposure.
|
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Perceived efficacy to prevent alcohol harms (questionnaire self-report)
Tidsram: 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.
|
Assessed immediately after stimulus exposure.
|
|
Attitudes about alcohol consumption (questionnaire self-report)
Tidsram: Assessed immediately after stimulus exposure.
|
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)
Tidsram: 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.
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Assessed immediately after stimulus exposure.
|
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Intentions to seek information about alcohol health effects and cancer screenings (questionnaire self-report)
Tidsram: 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.
|
Assessed immediately after stimulus exposure.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Attention to warning statements (questionnaire self-report)
Tidsram: Assessed immediately after stimulus exposure.
|
Continuous self-report measure (1 to 9) of attention to experimental images.
|
Assessed immediately after stimulus exposure.
|
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Perceived message effectiveness (questionnaire self-report)
Tidsram: Assessed immediately after stimulus exposure.
|
Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.
|
Assessed immediately after stimulus exposure.
|
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Reactance (questionnaire self-report)
Tidsram: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) of opposition to the health warning information in experimental images.
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Assessed immediately after stimulus exposure.
|
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Emotional responses (questionnaire self-report)
Tidsram: Assessed immediately after stimulus exposure.
|
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)
Tidsram: Assessed immediately after stimulus exposure.
|
Continuous self-report measure (1 to 9) for appeal of products in experimental images.
|
Assessed immediately after stimulus exposure.
|
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Unaided recall (i.e., correctly recalling health effects described in warnings)
Tidsram: 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.
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Assessed immediately after stimulus exposure.
|
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"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)
Tidsram: Assessed immediately after stimulus exposure.
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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.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
27 juli 2026
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
1 september 2026
Studieregistreringsdatum
Först inskickad
27 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
8 september 2026
Första postat (Faktisk)
10 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 18774
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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