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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA180907 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Constituent message with FDA and quitline | Experimental | 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. |
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| Constituent message without FDA and quitline | Experimental | 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. |
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| Littering message (Control) | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33625509 | Derived | 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. |
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845 participants consented to participate in the study, of those 41 did not complete the baseline questionnaire and were not randomized. Of the 804 originally reported 12 were ineligible since they were not current smokers, 1 person withdrew, and 2 were duplicates. Our final analytic sample is 789.
Participants were recruited and screened for study eligiblity online between June 2017 and April 2018, and invited to enroll after the study started and they were determined to be eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 r |
| FG001 | 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. 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 |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 r |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants who responded to the measure at the time point of interest |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who responded to the measure at the time point of interest, post 1 (day 16) | Posted | Mean | Standard Deviation | score on a scale | day 16 |
|
Low risk study, no adverse event data collected
Low risk study, no adverse event data collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 r |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam O. Goldstein | University of North Carolina at Chapel Hill | 984-974-0210 | adam_goldstein@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 21, 2020 | Aug 27, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D014486 | United States Food and Drug Administration |
| ID | Term |
|---|---|
| D014492 | United States Public Health Service |
| D014483 | United States Dept. of Health and Human Services |
| D037041 | United States Government Agencies |
| D035082 | Federal Government |
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| 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. |
|
| 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 |
| BG001 | 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. 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 |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. 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 |
| OG002 | 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. 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. |
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| Secondary | Number of Cigarettes Smoked Each Day | Measured daily by survey | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Mean | Standard Deviation | Number of cigarettes smoked each day | days 1-15 |
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| Secondary | Number of Cigarettes Forgone Each Day | Measured daily by survey | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Mean | Standard Deviation | Number of cigarettes forgone each day | days 1-15 |
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| Secondary | Number of Cigarettes Butted Out Each Day | Measured daily by survey | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Mean | Standard Deviation | Number of cigarettes butted out per day | days 1-15 |
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| Secondary | Quit Attempts During the Study | Measured by survey | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Count of Participants | Participants | days 16 and 32 |
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| Secondary | Awareness of Quitline | Measured by survey | Participants who responded to the measure at the time point of interest, post 1 (day 16) | Posted | Count of Participants | Participants | day 16 |
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| Secondary | Recall of Quitline Phone Number | Measured by survey | Participants who responded to the measure at the time point of interest, post 1 (day 16) | Posted | Count of Participants | Participants | day 16 |
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| Secondary | Use of Quitline During the Study | Measured by survey | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Count of Participants | Participants | days 16 and 32 |
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| 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. | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Mean | Standard Deviation | units on a scale | days 16 and 32 |
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| 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. | Participants who responded to the measure at the time point of interest | Posted | Mean | Standard Deviation | score on a scale | day 32 |
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| 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. | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Mean | Standard Deviation | units on a scale | days 16 and 32 |
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| 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. | Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure for at least one time point. Participants who responded to the measure at the time point of interest are included in the row for that time point, but participants that did not are excluded for that day. | Posted | Mean | Standard Deviation | units on a scale | days 16 and 32 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006076 | Government |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| Title | Measurements |
|---|---|
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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