Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
8 de septiembre de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
2000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zachary Massey, PhD
- Número de teléfono: (405) 271-6872
- Correo electrónico: zachary-massey@ou.edu
Ubicaciones de estudio
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Reclutamiento
- University of Oklahoma Health Campus, Health Promotion Research Center
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Contacto:
- Zachary Massey, PhD
- Número de teléfono: 405-271-6872
- Correo electrónico: zachary-massey@ou.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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).
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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.
|
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).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Risk perceptions of alcohol harms (questionnaire self-report)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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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)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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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.
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Assessed immediately after stimulus exposure.
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Attitudes about alcohol consumption (questionnaire self-report)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 7) for attitudes about alcohol consumption.
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Assessed immediately after stimulus exposure.
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Intentions to quit or reduce drinking alcohol (questionnaire self-report)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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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)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for intentions to seek information about the health effects of alcohol, including cancer screenings.
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Assessed immediately after stimulus exposure.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Attention to warning statements (questionnaire self-report)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) of attention to experimental images.
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Assessed immediately after stimulus exposure.
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Perceived message effectiveness (questionnaire self-report)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.
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Assessed immediately after stimulus exposure.
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Reactance (questionnaire self-report)
Periodo de tiempo: 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)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for strength of positive to negative feeling/emotions about the experimental images.
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Assessed immediately after stimulus exposure.
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Alcohol product appeal (questionnaire self-report)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for appeal of products in experimental images.
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Assessed immediately after stimulus exposure.
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Unaided recall (i.e., correctly recalling health effects described in warnings)
Periodo de tiempo: Assessed immediately after stimulus exposure.
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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)
Periodo de tiempo: 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.
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Assessed immediately after stimulus exposure.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de julio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 18774
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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