Enhancing Source Credibility in Tobacco Regulatory Communications
20 november 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
845
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina at Chapel Hill
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quit Intentions
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Cigarettes Smoked Each Day
Tidsram: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Forgone Each Day
Tidsram: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Butted Out Each Day
Tidsram: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Quit Attempts During the Study
Tidsram: days 16 and 32
|
Measured by survey
|
days 16 and 32
|
|
Awareness of Quitline
Tidsram: day 16
|
Measured by survey
|
day 16
|
|
Recall of Quitline Phone Number
Tidsram: day 16
|
Measured by survey
|
day 16
|
|
Use of Quitline During the Study
Tidsram: days 16 and 32
|
Measured by survey
|
days 16 and 32
|
|
Intention to Use the Quitline
Tidsram: 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
Tidsram: 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
|
|
Self Efficacy
Tidsram: 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.
|
days 16 and 32
|
|
Response Efficacy
Tidsram: 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.
|
days 16 and 32
|
Samarbetspartners och utredare
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Samarbetspartners
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 oktober 2017
Primärt slutförande (Faktisk)
6 maj 2018
Avslutad studie (Faktisk)
23 maj 2018
Studieregistreringsdatum
Först inskickad
7 november 2017
Först inskickad som uppfyllde QC-kriterierna
7 november 2017
Första postat (Faktisk)
13 november 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 november 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 november 2020
Senast verifierad
1 november 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 17-0610
- P50CA180907 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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