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

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

2000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Recrutement
        • University of Oklahoma Health Campus, Health Promotion Research Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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).
Expérimental: 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.
Comportemental: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Risk perceptions of alcohol harms (questionnaire self-report)
Délai: 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.
Assessed immediately after stimulus exposure.
Perceived efficacy to prevent alcohol harms (questionnaire self-report)
Délai: 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)
Délai: 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)
Délai: 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.
Assessed immediately after stimulus exposure.
Intentions to seek information about alcohol health effects and cancer screenings (questionnaire self-report)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Attention to warning statements (questionnaire self-report)
Délai: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) of attention to experimental images.
Assessed immediately after stimulus exposure.
Perceived message effectiveness (questionnaire self-report)
Délai: 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.
Reactance (questionnaire self-report)
Délai: Assessed immediately after stimulus exposure.
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)
Délai: 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)
Délai: Assessed immediately after stimulus exposure.
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)
Délai: 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.
Assessed immediately after stimulus exposure.
"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)
Délai: Assessed immediately after stimulus exposure.
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Oklahoma

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 juillet 2026

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

27 août 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

10 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 18774

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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