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

10 avril 2018 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

866

Phase

  • N'est pas applicable

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 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: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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

Expérimental: 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

Expérimental: 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

Expérimental: 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

Expérimental: 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

Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
numeric risk recall
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
smoking risk perceptions
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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

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)

16 avril 2016

Achèvement primaire (Réel)

2 juin 2016

Achèvement de l'étude (Réel)

2 juin 2016

Dates d'inscription aux études

Première soumission

10 avril 2018

Première soumission répondant aux critères de contrôle qualité

10 avril 2018

Première publication (Réel)

18 avril 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 avril 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • P50CA180908A2b
  • P50CA180908 (Subvention/contrat des NIH des États-Unis)

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 .

Essais cliniques sur retarder le post-test

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