Enhancing Source Credibility in Tobacco Regulatory Communications
20 november 2020 bijgewerkt door: Adam Goldstein, MD, MPH, UNC Lineberger Comprehensive Cancer Center
This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
The investigators hypothesize that cigarette constituent messages will increase intention to quit compared to messages about littering cigarettes (the control).
The investigators also hypothesize that constituent messages that include FDA source and quit information will increase intention to quit compared to messages without that information.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
The Family Smoking Prevention and Tobacco Control Act delegates the U.S. Food and Drug Administration (FDA) to communicate the risks of smoking to the public, among other tobacco regulatory responsibilities. Little research exists about how FDA, as a regulatory agency, should develop and deliver these messages, and whether they should include their source information on the ads. This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
Recruitment: People interested in participating will complete an online screener. Study staff will invite people eligible based on the screener to enroll in the study.
Informed Consent: The consent form will be shared with people who are eligible based on the screener in the invitation email. At the beginning of the baseline survey, participants will again review the consent form and will be asked to provide consent in order to enroll in the study.
Randomization: At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. Participants will have an equal chance of being randomized to each study arm.
Assessment: Participants will complete 18 computer based surveys during the study. The first baseline survey will take around 20 minutes to complete on day 0. Participants will then receive a survey each morning for days 1-15 that will include behavior measures as well as their assigned study intervention. These surveys will take approximately 5 minutes to complete. Participants will then complete a 20-minute survey on day 16, and day 32.
Detailed description of the intervention: Participants will receive an email with a link to a survey each morning for 15 days. During that survey they will be shown one message from their condition. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators designed the messages.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
845
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- University of North Carolina at Chapel Hill
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Have smoked at least 100 cigarettes in his or her lifetime
- Currently smoke cigarettes every day or some days
- Work or home access to the internet
- Email account that is regularly used
- Lives in the US
- Comfortable taking a survey in English
- Able to complete a survey on a computer
- Able to complete surveys delivered via email
- Able to complete 3, 20 minute surveys during the study
- Able to complete surveys in the morning for 15 days
Exclusion Criteria:
- Currently using pharmacotherapy, a quitline, or a quit smoking program or support group for smoking cessation
- Participated in a research study about smoking cigarettes or using other tobacco products in the last 3 months
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Constituent message with FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
|
Experimenteel: Constituent message without FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm is identical to the arm above, except that it does not include FDA source or quit information.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm is identical to the arm above, except that it does not include FDA source or quit information.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
|
Ander: Littering message (Control)
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quit Intentions
Tijdsspanne: day 16
|
Average quit intention score measured at 16 days by survey.
Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
|
day 16
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Cigarettes Smoked Each Day
Tijdsspanne: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Forgone Each Day
Tijdsspanne: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Butted Out Each Day
Tijdsspanne: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Quit Attempts During the Study
Tijdsspanne: days 16 and 32
|
Measured by survey
|
days 16 and 32
|
|
Awareness of Quitline
Tijdsspanne: day 16
|
Measured by survey
|
day 16
|
|
Recall of Quitline Phone Number
Tijdsspanne: day 16
|
Measured by survey
|
day 16
|
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Use of Quitline During the Study
Tijdsspanne: days 16 and 32
|
Measured by survey
|
days 16 and 32
|
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Intention to Use the Quitline
Tijdsspanne: days 16 and 32
|
Measured by survey.
Intention to use the quitline was measured with one item on a 1 to 4 scale, where 1 indicates a low likelihood of calling the quitline, and 4 indicates a high likelihood of calling the quitline.
|
days 16 and 32
|
|
Quit Intentions
Tijdsspanne: day 32
|
Average quit intention score measured at 32 days by survey.
Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
|
day 32
|
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Self Efficacy
Tijdsspanne: days 16 and 32
|
Measured by survey.
Self efficacy measured with 1 question, on a scale of 1 to 5, where 1 indicates low self efficacy to quit, and 5 indicates a high self efficacy to quit smoking cigarettes.
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days 16 and 32
|
|
Response Efficacy
Tijdsspanne: days 16 and 32
|
Measured by survey.
Response efficacy measured with 1 question, on a scale of 1 to 5, where 1 indicates low response efficacy of quitting, and 5 indicates a high response efficacy of quitting smoking cigarettes.
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days 16 and 32
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 oktober 2017
Primaire voltooiing (Werkelijk)
6 mei 2018
Studie voltooiing (Werkelijk)
23 mei 2018
Studieregistratiedata
Eerst ingediend
7 november 2017
Eerst ingediend dat voldeed aan de QC-criteria
7 november 2017
Eerst geplaatst (Werkelijk)
13 november 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 november 2020
Laatste update ingediend die voldeed aan QC-criteria
20 november 2020
Laatst geverifieerd
1 november 2020
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 17-0610
- P50CA180907 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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