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

8 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

2000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • University of Oklahoma Health Campus, Health Promotion Research Center
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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).
Experimental: 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.
Comportamental: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Risk perceptions of alcohol harms (questionnaire self-report)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Attention to warning statements (questionnaire self-report)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Oklahoma

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de julho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

1 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

27 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de setembro de 2026

Primeira postagem (Real)

10 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 18774

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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