Skip to main content
OpenTrials
Completed

NCT Number: NCT03339206

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cigarette Smoking Behavior Behavior Cigarette Smoking Smoking Tobacco Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constituent message with FDA and quitline

Behavioral

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

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Quit Intentions

    Time frame: 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.

Secondary outcomes

  1. Number of Cigarettes Smoked Each Day

    Time frame: days 1-15

    Measured daily by survey

  2. Number of Cigarettes Forgone Each Day

    Time frame: days 1-15

    Measured daily by survey

  3. Number of Cigarettes Butted Out Each Day

    Time frame: days 1-15

    Measured daily by survey

  4. Quit Attempts During the Study

    Time frame: days 16 and 32

    Measured by survey

  5. Awareness of Quitline

    Time frame: day 16

    Measured by survey

  6. Recall of Quitline Phone Number

    Time frame: day 16

    Measured by survey

  7. Use of Quitline During the Study

    Time frame: days 16 and 32

    Measured by survey

  8. Intention to Use the Quitline

    Time frame: 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.

  9. Quit Intentions

    Time frame: 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.

  10. Self Efficacy

    Time frame: 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.

  11. Response Efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2017
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.