- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03501472
Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
numeric risk recall
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
smoking risk perceptions
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- P50CA180908A2b
- P50CA180908 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Stoppen met roken
-
Boston UniversityFlight Attendant Medical Research InstituteVoltooid
-
Cedars-Sinai Medical CenterUniversity of California, San FranciscoVoltooidTweedehands smoking | Vasculaire verouderingVerenigde Staten
-
Peking Union Medical College HospitalRun Shaw Hospital, Zhejiang University School of Medicine; Hangzhou Medisol Technology...Nog niet aan het wervenTweedehands smoking | Passief roken | Verontreiniging door tabaksrookChina
-
Mustafa Kemal UniversityOnbekendTweedehands smokingKalkoen
Klinische onderzoeken op vertraging posttest
-
Ohio State UniversityUniversity of PennsylvaniaVoltooidStoppen met roken | Roken, Sigaret
-
Boston Scientific CorporationVoltooid
-
Cairo UniversityActief, niet wervendStress-urine-incontinentieEgypte
-
Imperial College LondonBritish Heart FoundationWervingHypertrofische cardiomyopathie | Hypertrofische obstructieve cardiomyopathieVerenigd Koninkrijk
-
Suleyman Demirel UniversityNog niet aan het wervenPremenstrueel syndroom | Familie kenmerken | Opdrachten | Stress niveauKalkoen
-
University of California, San DiegoVoltooidAtrioventriculair blok | Hartritmestoornissen | Ziek sinussyndroom | Symptomatische bradycardieVerenigde Staten
-
UNC Lineberger Comprehensive Cancer CenterVoltooidLongneoplasmata | Basisgezondheidszorg | Beslissingsondersteunende technieken | Vroege detectie van kankerVerenigde Staten
-
Suleyman Demirel UniversityVoltooidEchtelijke relatie | Seksuele functie | PostmenopauzeKalkoen
-
Chung Shan Medical UniversityMinistry of Education, TaiwanVoltooidLongontsteking | Astma | Borstvliesuitstroming | Ademhalingsgeluid | AuscultatieTaiwan
-
Hiroshima UniversityWervingGezondheidsgeletterdheidBangladesh