Enhancing Source Credibility in Tobacco Regulatory Communications

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Cigarette Smoking Behavior

Treatments: Behavioral: Constituent message without FDA and quitline; Behavioral: Constituent message with FDA and quitline; Behavioral: Littering message (Control)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03339206

P50CA180907 (U.S. NIH Grant/Contract)

17-0610

Details and patient eligibility

About

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.

Full 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.

Enrollment: 845 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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845 participants in 3 patient groups

Constituent message with FDA and quitline

Experimental group

Description:

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.

Treatment:

Behavioral: Constituent message with FDA and quitline

Constituent message without FDA and quitline

Experimental group

Description:

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.

Treatment:

Behavioral: Constituent message without FDA and quitline

Littering message (Control)

Other group

Description:

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.

Treatment:

Behavioral: Littering message (Control)