Enhancing Source Credibility in Tobacco Regulatory Communications

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking Behavior
• Intervention / Treatment: Behavioral: Constituent message with FDA and quitline; Behavioral: Constituent message without FDA and quitline; Behavioral: Littering message (Control)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 845
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Behavioral: 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.
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cigarettes Smoked Each Day	Measured daily by survey	days 1-15
Number of Cigarettes Forgone Each Day	Measured daily by survey	days 1-15
Number of Cigarettes Butted Out Each Day	Measured daily by survey	days 1-15
Quit Attempts During the Study	Measured by survey	days 16 and 32
Awareness of Quitline	Measured by survey	day 16
Recall of Quitline Phone Number	Measured by survey	day 16
Use of Quitline During the Study	Measured by survey	days 16 and 32
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
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
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
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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Goldstein AO, Jarman KL, Kowitt SD, Queen TL, Kim KS, Shook-Sa BE, Sheeran P, Noar SM, Ranney LM. Effect of Cigarette Constituent Messages With Engagement Text on Intention to Quit Smoking Among Adults Who Smoke Cigarettes: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210045. doi: 10.1001/jamanetworkopen.2021.0045.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): May 6, 2018
• Study Completion (Actual): May 23, 2018

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17-0610; P50CA180907 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No