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Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time

10 de abril de 2018 actualizado por: Ellen Peters, Ohio State University
Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks, or for numeric risks (e.g., percentage risk for developing lung cancer). This trial tests memory for numeric health risks immediately or after a six-week delay for US adult smokers. In addition, the trial tests the effects of different warning label components (e.g., whether the numeric risks are percentage or frequency), participants' level of numeric ability, and the consequences of memory for numeric risks on participant risk perceptions and quit intentions.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

866

Fase

  • No aplica

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • at least 18 years old
  • have smoked 100+ lifetime cigarettes
  • currently smoke "every day" or "some days."
  • US resident

Exclusion Criteria:

  • have not ever smoked a cigarette

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Text-only PWL, immediate post

Exposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels

Experimental: Text-only PWL, delay posttest

Exposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels

Experimental: Low-emot PWL, immed post

Exposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels

Experimental: Low-emot PWL, delay posttest

Exposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels

Experimental: High-emot PWL, immed posttest

Exposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels

Experimental: High-emot PWL, delay posttest

Exposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
numeric risk recall
Periodo de tiempo: immediately following last exposure or after 6-week delay
free recall for numeric risks presented in labels (e.g., ____% of smokers die before age 85), both for smokers and nonsmokers
immediately following last exposure or after 6-week delay
numeric risk recognition
Periodo de tiempo: immediately following last exposure or after 6-week delay
Participants answered one multiple choice question about the numeric risk for smokers and nonsmokers (combined in one question) for each of the 8 outcomes that had been paired with the PWLs. For each question, there were four decoy responses.
immediately following last exposure or after 6-week delay

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
smoking risk perceptions
Periodo de tiempo: immediately following last exposure or after 6-week delay

Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "Compared to the average nonsmoker your age, gender, and race, how would you rate your chances of": 1) "getting a life threatening illness because of smoking," 2) "getting lung cancer," and 3) "dying at a younger age than average" (-3 = Much lower, +3 = Much higher))

They also gave verbal likelihood ratings for each of the 8 outcomes of smoking that had been paired with the labels (e.g., "Thinking of risks that you were shown in the warnings, what is the likelihood of a smoker [non-smoker] dying from heart disease?," 0=impossible, 11=certain)

immediately following last exposure or after 6-week delay
smoking risk knowledge
Periodo de tiempo: immediately following last exposure or after 6-week delay
Participants listed as many risks of smoking as they could think of.
immediately following last exposure or after 6-week delay
quit intentions
Periodo de tiempo: immediately following last exposure or after 6-week delay
Participants intentions to quit smoking, Likelihood of smoking within next 30 days, next year (-3 = very unlikely, 3 = very likely)
immediately following last exposure or after 6-week delay

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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)

16 de abril de 2016

Finalización primaria (Actual)

2 de junio de 2016

Finalización del estudio (Actual)

2 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

10 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

10 de abril de 2018

Publicado por primera vez (Actual)

18 de abril de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de abril de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

10 de abril de 2018

Última verificación

1 de abril de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • P50CA180908A2b
  • P50CA180908 (Subvención/contrato del NIH de EE. UU.)

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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