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

10. april 2018 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

866

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Eksperimentel: 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

Eksperimentel: 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

Eksperimentel: 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

Eksperimentel: 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

Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
numeric risk recall
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
smoking risk perceptions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2016

Primær færdiggørelse (Faktiske)

2. juni 2016

Studieafslutning (Faktiske)

2. juni 2016

Datoer for studieregistrering

Først indsendt

10. april 2018

Først indsendt, der opfyldte QC-kriterier

10. april 2018

Først opslået (Faktiske)

18. april 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • P50CA180908A2b
  • P50CA180908 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med forsinket posttest

3
Abonner