Enhancing Source Credibility in Tobacco Regulatory Communications

Cigarette Smoking Behavior Clinical Trial

Official title:

Enhancing Source Credibility in Tobacco Regulatory Communications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339206
• Other study ID #: 17-0610
• Secondary ID: P50CA180907
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: May 23, 2018

Study information

• Verified date: November 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 845
• Est. completion date: May 23, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking Behavior

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Intentions	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
Secondary	Number of Cigarettes Smoked Each Day	Measured daily by survey	days 1-15
Secondary	Number of Cigarettes Forgone Each Day	Measured daily by survey	days 1-15
Secondary	Number of Cigarettes Butted Out Each Day	Measured daily by survey	days 1-15
Secondary	Quit Attempts During the Study	Measured by survey	days 16 and 32
Secondary	Awareness of Quitline	Measured by survey	day 16
Secondary	Recall of Quitline Phone Number	Measured by survey	day 16
Secondary	Use of Quitline During the Study	Measured by survey	days 16 and 32
Secondary	Intention to Use the Quitline	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
Secondary	Quit Intentions	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
Secondary	Self Efficacy	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
Secondary	Response Efficacy	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