Cigarette Smoking Behavior
Conditions
Brief 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.
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.
Interventions
BEHAVIORALConstituent 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.
BEHAVIORALConstituent 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.
BEHAVIORALLittering 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.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Intentions | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Cigarettes Forgone Each Day | days 1-15 | Measured daily by survey |
| Number of Cigarettes Butted Out Each Day | days 1-15 | Measured daily by survey |
| Quit Attempts During the Study | days 16 and 32 | Measured by survey |
| Awareness of Quitline | day 16 | Measured by survey |
| Recall of Quitline Phone Number | day 16 | Measured by survey |
| Number of Cigarettes Smoked Each Day | days 1-15 | Measured daily by survey |
| Intention to Use the Quitline | 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. |
| Quit Intentions | 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. |
| Self Efficacy | 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. |
| Response Efficacy | 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. |
| Use of Quitline During the Study | days 16 and 32 | Measured by survey |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 262 |
| 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 | 263 |
| 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. | 264 |
| Total | 789 |
Baseline characteristics
| Characteristic | Constituent Message With FDA and Quitline | Constituent Message Without FDA and Quitline | Littering Message (Control) | Total |
|---|---|---|---|---|
| Age, Continuous | 43.95 years STANDARD_DEVIATION 12.88 | 42.83 years STANDARD_DEVIATION 12.71 | 43.33 years STANDARD_DEVIATION 13.08 | 43.37 years STANDARD_DEVIATION 12.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 27 Participants | 23 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 240 Participants | 236 Participants | 241 Participants | 717 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 52 Participants | 63 Participants | 49 Participants | 164 Participants |
| Race/Ethnicity, Customized Other Race | 18 Participants | 19 Participants | 10 Participants | 47 Participants |
| Race/Ethnicity, Customized White | 192 Participants | 181 Participants | 205 Participants | 578 Participants |
| Region of Enrollment United States | 262 Participants | 263 Participants | 264 Participants | 789 Participants |
| Sex/Gender, Customized Female | 161 Participants | 166 Participants | 156 Participants | 483 Participants |
| Sex/Gender, Customized Gender non-conforming | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Sex/Gender, Customized Male | 99 Participants | 96 Participants | 106 Participants | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: day 16
Population: Participants who responded to the measure at the time point of interest, post 1 (day 16)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constituent Message With FDA and Quitline | Quit Intentions | 2.73 score on a scale | Standard Deviation 0.95 |
| Constituent Message Without FDA and Quitline | Quit Intentions | 2.67 score on a scale | Standard Deviation 0.94 |
| Littering Message (Control) | Quit Intentions | 2.58 score on a scale | Standard Deviation 1 |
Secondary
Awareness of Quitline
Measured by survey
Time frame: day 16
Population: Participants who responded to the measure at the time point of interest, post 1 (day 16)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Constituent Message With FDA and Quitline | Awareness of Quitline | Aware of Quitline | 122 Participants |
| Constituent Message With FDA and Quitline | Awareness of Quitline | Not Aware of Quitline | 110 Participants |
| Constituent Message Without FDA and Quitline | Awareness of Quitline | Aware of Quitline | 107 Participants |
| Constituent Message Without FDA and Quitline | Awareness of Quitline | Not Aware of Quitline | 125 Participants |
| Littering Message (Control) | Awareness of Quitline | Aware of Quitline | 95 Participants |
| Littering Message (Control) | Awareness of Quitline | Not Aware of Quitline | 134 Participants |
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.
Time frame: days 16 and 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Constituent Message With FDA and Quitline | Intention to Use the Quitline | Post 1 (day 16) | 2.34 units on a scale | Standard Deviation 1.14 |
| Constituent Message With FDA and Quitline | Intention to Use the Quitline | Post 2 (day 32) | 2.42 units on a scale | Standard Deviation 1.14 |
| Constituent Message Without FDA and Quitline | Intention to Use the Quitline | Post 1 (day 16) | 2.25 units on a scale | Standard Deviation 1.09 |
| Constituent Message Without FDA and Quitline | Intention to Use the Quitline | Post 2 (day 32) | 2.29 units on a scale | Standard Deviation 1.09 |
| Littering Message (Control) | Intention to Use the Quitline | Post 1 (day 16) | 2.18 units on a scale | Standard Deviation 1.1 |
| Littering Message (Control) | Intention to Use the Quitline | Post 2 (day 32) | 2.10 units on a scale | Standard Deviation 1.12 |
Secondary
Number of Cigarettes Butted Out Each Day
Measured daily by survey
Time frame: days 1-15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 6 | 1.89 Number of cigarettes butted out per day | Standard Deviation 3.19 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 3 | 1.72 Number of cigarettes butted out per day | Standard Deviation 2.6 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 11 | 2.19 Number of cigarettes butted out per day | Standard Deviation 7.69 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 7 | 1.72 Number of cigarettes butted out per day | Standard Deviation 2.88 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 2 | 1.69 Number of cigarettes butted out per day | Standard Deviation 2.78 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 10 | 2.15 Number of cigarettes butted out per day | Standard Deviation 7.75 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 8 | 2.26 Number of cigarettes butted out per day | Standard Deviation 7.71 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 13 | 2.06 Number of cigarettes butted out per day | Standard Deviation 7.52 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 9 | 2.12 Number of cigarettes butted out per day | Standard Deviation 7.65 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 4 | 1.72 Number of cigarettes butted out per day | Standard Deviation 2.59 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 15 | 2.11 Number of cigarettes butted out per day | Standard Deviation 7.45 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 1 | 1.42 Number of cigarettes butted out per day | Standard Deviation 2.28 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 5 | 2.28 Number of cigarettes butted out per day | Standard Deviation 7.66 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 14 | 1.59 Number of cigarettes butted out per day | Standard Deviation 2.26 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 12 | 2.04 Number of cigarettes butted out per day | Standard Deviation 7.46 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 12 | 1.44 Number of cigarettes butted out per day | Standard Deviation 2.05 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 1 | 1.53 Number of cigarettes butted out per day | Standard Deviation 2.1 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 2 | 1.44 Number of cigarettes butted out per day | Standard Deviation 2.21 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 3 | 1.49 Number of cigarettes butted out per day | Standard Deviation 2.04 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 4 | 1.59 Number of cigarettes butted out per day | Standard Deviation 2.09 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 5 | 1.63 Number of cigarettes butted out per day | Standard Deviation 2.04 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 6 | 1.54 Number of cigarettes butted out per day | Standard Deviation 2.03 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 7 | 1.55 Number of cigarettes butted out per day | Standard Deviation 2.04 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 8 | 1.62 Number of cigarettes butted out per day | Standard Deviation 2.11 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 9 | 1.57 Number of cigarettes butted out per day | Standard Deviation 2.15 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 10 | 1.22 Number of cigarettes butted out per day | Standard Deviation 1.68 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 11 | 1.43 Number of cigarettes butted out per day | Standard Deviation 1.93 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 13 | 1.36 Number of cigarettes butted out per day | Standard Deviation 1.98 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 14 | 1.57 Number of cigarettes butted out per day | Standard Deviation 2.14 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Butted Out Each Day | Day 15 | 1.51 Number of cigarettes butted out per day | Standard Deviation 2.27 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 6 | 1.88 Number of cigarettes butted out per day | Standard Deviation 3.68 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 14 | 2.01 Number of cigarettes butted out per day | Standard Deviation 3.45 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 11 | 2.07 Number of cigarettes butted out per day | Standard Deviation 3.7 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 5 | 1.99 Number of cigarettes butted out per day | Standard Deviation 3.73 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 4 | 2.15 Number of cigarettes butted out per day | Standard Deviation 4.34 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 12 | 1.95 Number of cigarettes butted out per day | Standard Deviation 3.41 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 3 | 1.71 Number of cigarettes butted out per day | Standard Deviation 2.6 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 1 | 1.91 Number of cigarettes butted out per day | Standard Deviation 3.12 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 13 | 1.82 Number of cigarettes butted out per day | Standard Deviation 3.25 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 8 | 1.95 Number of cigarettes butted out per day | Standard Deviation 3.35 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 2 | 2.11 Number of cigarettes butted out per day | Standard Deviation 3.64 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 9 | 1.81 Number of cigarettes butted out per day | Standard Deviation 3.34 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 7 | 1.87 Number of cigarettes butted out per day | Standard Deviation 3.44 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 15 | 1.84 Number of cigarettes butted out per day | Standard Deviation 3.38 |
| Littering Message (Control) | Number of Cigarettes Butted Out Each Day | Day 10 | 2.16 Number of cigarettes butted out per day | Standard Deviation 3.86 |
Secondary
Number of Cigarettes Forgone Each Day
Measured daily by survey
Time frame: days 1-15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 6 | 2.24 Number of cigarettes forgone each day | Standard Deviation 7.72 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 3 | 1.22 Number of cigarettes forgone each day | Standard Deviation 1.7 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 11 | 1.94 Number of cigarettes forgone each day | Standard Deviation 7.57 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 7 | 1.68 Number of cigarettes forgone each day | Standard Deviation 2.34 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 2 | 1.11 Number of cigarettes forgone each day | Standard Deviation 1.53 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 10 | 2.12 Number of cigarettes forgone each day | Standard Deviation 7.67 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 8 | 2.15 Number of cigarettes forgone each day | Standard Deviation 7.61 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 13 | 1.92 Number of cigarettes forgone each day | Standard Deviation 7.36 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 9 | 2.17 Number of cigarettes forgone each day | Standard Deviation 7.53 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 4 | 1.39 Number of cigarettes forgone each day | Standard Deviation 1.97 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 15 | 2.00 Number of cigarettes forgone each day | Standard Deviation 7.31 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 1 | 1.08 Number of cigarettes forgone each day | Standard Deviation 1.87 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 5 | 2.05 Number of cigarettes forgone each day | Standard Deviation 7.57 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 14 | 1.42 Number of cigarettes forgone each day | Standard Deviation 2.07 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 12 | 1.89 Number of cigarettes forgone each day | Standard Deviation 7.3 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 12 | 1.55 Number of cigarettes forgone each day | Standard Deviation 2.01 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 1 | 0.91 Number of cigarettes forgone each day | Standard Deviation 1.2 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 2 | 1.12 Number of cigarettes forgone each day | Standard Deviation 1.48 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 3 | 1.38 Number of cigarettes forgone each day | Standard Deviation 1.72 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 4 | 1.30 Number of cigarettes forgone each day | Standard Deviation 1.52 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 5 | 1.43 Number of cigarettes forgone each day | Standard Deviation 2.35 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 6 | 1.35 Number of cigarettes forgone each day | Standard Deviation 1.66 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 7 | 1.53 Number of cigarettes forgone each day | Standard Deviation 1.92 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 8 | 1.61 Number of cigarettes forgone each day | Standard Deviation 2.01 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 9 | 1.40 Number of cigarettes forgone each day | Standard Deviation 1.83 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 10 | 1.40 Number of cigarettes forgone each day | Standard Deviation 1.89 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 11 | 1.46 Number of cigarettes forgone each day | Standard Deviation 1.79 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 13 | 1.36 Number of cigarettes forgone each day | Standard Deviation 1.86 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 14 | 1.38 Number of cigarettes forgone each day | Standard Deviation 1.6 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Forgone Each Day | Day 15 | 1.53 Number of cigarettes forgone each day | Standard Deviation 1.97 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 6 | 1.40 Number of cigarettes forgone each day | Standard Deviation 2.33 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 14 | 1.57 Number of cigarettes forgone each day | Standard Deviation 2.29 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 11 | 1.63 Number of cigarettes forgone each day | Standard Deviation 2.36 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 5 | 1.83 Number of cigarettes forgone each day | Standard Deviation 7.54 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 4 | 1.66 Number of cigarettes forgone each day | Standard Deviation 3.9 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 12 | 1.63 Number of cigarettes forgone each day | Standard Deviation 2.53 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 3 | 1.37 Number of cigarettes forgone each day | Standard Deviation 2.17 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 1 | 1.30 Number of cigarettes forgone each day | Standard Deviation 2.1 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 13 | 1.42 Number of cigarettes forgone each day | Standard Deviation 2.22 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 8 | 1.48 Number of cigarettes forgone each day | Standard Deviation 2.31 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 2 | 1.29 Number of cigarettes forgone each day | Standard Deviation 1.82 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 9 | 1.55 Number of cigarettes forgone each day | Standard Deviation 2.61 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 7 | 1.52 Number of cigarettes forgone each day | Standard Deviation 2.1 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 15 | 1.52 Number of cigarettes forgone each day | Standard Deviation 2.68 |
| Littering Message (Control) | Number of Cigarettes Forgone Each Day | Day 10 | 1.62 Number of cigarettes forgone each day | Standard Deviation 2.62 |
Secondary
Number of Cigarettes Smoked Each Day
Measured daily by survey
Time frame: days 1-15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 6 | 14.15 Number of cigarettes smoked each day | Standard Deviation 10.42 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 3 | 15.41 Number of cigarettes smoked each day | Standard Deviation 10.61 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 11 | 14.24 Number of cigarettes smoked each day | Standard Deviation 10.24 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 7 | 13.91 Number of cigarettes smoked each day | Standard Deviation 10.17 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 2 | 15.79 Number of cigarettes smoked each day | Standard Deviation 10.39 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 10 | 14.15 Number of cigarettes smoked each day | Standard Deviation 10.66 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 8 | 13.98 Number of cigarettes smoked each day | Standard Deviation 9.93 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 13 | 14.23 Number of cigarettes smoked each day | Standard Deviation 9.76 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 9 | 14.40 Number of cigarettes smoked each day | Standard Deviation 10.97 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 4 | 15.00 Number of cigarettes smoked each day | Standard Deviation 10.24 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 15 | 13.75 Number of cigarettes smoked each day | Standard Deviation 10.09 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 1 | 15.06 Number of cigarettes smoked each day | Standard Deviation 9.16 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 5 | 14.35 Number of cigarettes smoked each day | Standard Deviation 9.8 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 14 | 14.53 Number of cigarettes smoked each day | Standard Deviation 10.64 |
| Constituent Message With FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 12 | 14.09 Number of cigarettes smoked each day | Standard Deviation 10.22 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 12 | 12.83 Number of cigarettes smoked each day | Standard Deviation 9.56 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 1 | 14.16 Number of cigarettes smoked each day | Standard Deviation 9.78 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 2 | 14.67 Number of cigarettes smoked each day | Standard Deviation 11.34 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 3 | 13.59 Number of cigarettes smoked each day | Standard Deviation 9.05 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 4 | 13.85 Number of cigarettes smoked each day | Standard Deviation 9.69 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 5 | 13.52 Number of cigarettes smoked each day | Standard Deviation 8.44 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 6 | 13.64 Number of cigarettes smoked each day | Standard Deviation 10.41 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 7 | 13.13 Number of cigarettes smoked each day | Standard Deviation 10.08 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 8 | 13.14 Number of cigarettes smoked each day | Standard Deviation 10.15 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 9 | 12.94 Number of cigarettes smoked each day | Standard Deviation 9.47 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 10 | 12.29 Number of cigarettes smoked each day | Standard Deviation 9.68 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 11 | 12.84 Number of cigarettes smoked each day | Standard Deviation 9.46 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 13 | 12.67 Number of cigarettes smoked each day | Standard Deviation 9.8 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 14 | 12.64 Number of cigarettes smoked each day | Standard Deviation 9.37 |
| Constituent Message Without FDA and Quitline | Number of Cigarettes Smoked Each Day | Day 15 | 11.92 Number of cigarettes smoked each day | Standard Deviation 8.69 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 6 | 13.60 Number of cigarettes smoked each day | Standard Deviation 9.56 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 14 | 13.87 Number of cigarettes smoked each day | Standard Deviation 9.16 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 11 | 13.40 Number of cigarettes smoked each day | Standard Deviation 9.16 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 5 | 14.56 Number of cigarettes smoked each day | Standard Deviation 9.67 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 4 | 14.59 Number of cigarettes smoked each day | Standard Deviation 8.69 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 12 | 13.57 Number of cigarettes smoked each day | Standard Deviation 9.37 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 3 | 14.27 Number of cigarettes smoked each day | Standard Deviation 8.58 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 1 | 15.77 Number of cigarettes smoked each day | Standard Deviation 10.14 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 13 | 13.25 Number of cigarettes smoked each day | Standard Deviation 9.1 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 8 | 13.37 Number of cigarettes smoked each day | Standard Deviation 9 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 2 | 15.94 Number of cigarettes smoked each day | Standard Deviation 9.82 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 9 | 13.74 Number of cigarettes smoked each day | Standard Deviation 9.93 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 7 | 13.64 Number of cigarettes smoked each day | Standard Deviation 8.99 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 15 | 13.65 Number of cigarettes smoked each day | Standard Deviation 8.63 |
| Littering Message (Control) | Number of Cigarettes Smoked Each Day | Day 10 | 13.51 Number of cigarettes smoked each day | Standard Deviation 8.75 |
Secondary
Quit Attempts During the Study
Measured by survey
Time frame: days 16 and 32
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Constituent Message With FDA and Quitline | Quit Attempts During the Study | Made Quit Attempt as of Post 1 (day 16) | 58 Participants |
| Constituent Message With FDA and Quitline | Quit Attempts During the Study | Made Quit Attempt as of Post 2 (day 32) | 90 Participants |
| Constituent Message Without FDA and Quitline | Quit Attempts During the Study | Made Quit Attempt as of Post 1 (day 16) | 59 Participants |
| Constituent Message Without FDA and Quitline | Quit Attempts During the Study | Made Quit Attempt as of Post 2 (day 32) | 99 Participants |
| Littering Message (Control) | Quit Attempts During the Study | Made Quit Attempt as of Post 1 (day 16) | 51 Participants |
| Littering Message (Control) | Quit Attempts During the Study | Made Quit Attempt as of Post 2 (day 32) | 105 Participants |
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.
Time frame: day 32
Population: Participants who responded to the measure at the time point of interest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constituent Message With FDA and Quitline | Quit Intentions | 2.78 score on a scale | Standard Deviation 0.97 |
| Constituent Message Without FDA and Quitline | Quit Intentions | 2.76 score on a scale | Standard Deviation 0.97 |
| Littering Message (Control) | Quit Intentions | 2.73 score on a scale | Standard Deviation 1.01 |
Secondary
Recall of Quitline Phone Number
Measured by survey
Time frame: day 16
Population: Participants who responded to the measure at the time point of interest, post 1 (day 16)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Constituent Message With FDA and Quitline | Recall of Quitline Phone Number | Correctly recalled Quitline phone number | 70 Participants |
| Constituent Message With FDA and Quitline | Recall of Quitline Phone Number | Did not correctly recall Quitline phone number | 162 Participants |
| Constituent Message Without FDA and Quitline | Recall of Quitline Phone Number | Correctly recalled Quitline phone number | 45 Participants |
| Constituent Message Without FDA and Quitline | Recall of Quitline Phone Number | Did not correctly recall Quitline phone number | 187 Participants |
| Littering Message (Control) | Recall of Quitline Phone Number | Correctly recalled Quitline phone number | 49 Participants |
| Littering Message (Control) | Recall of Quitline Phone Number | Did not correctly recall Quitline phone number | 180 Participants |
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.
Time frame: days 16 and 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Constituent Message With FDA and Quitline | Response Efficacy | Post 1 (day 16) | 4.24 units on a scale | Standard Deviation 0.96 |
| Constituent Message With FDA and Quitline | Response Efficacy | Post 2 (day 32) | 4.40 units on a scale | Standard Deviation 0.9 |
| Constituent Message Without FDA and Quitline | Response Efficacy | Post 1 (day 16) | 4.26 units on a scale | Standard Deviation 0.97 |
| Constituent Message Without FDA and Quitline | Response Efficacy | Post 2 (day 32) | 4.36 units on a scale | Standard Deviation 0.96 |
| Littering Message (Control) | Response Efficacy | Post 1 (day 16) | 4.31 units on a scale | Standard Deviation 0.96 |
| Littering Message (Control) | Response Efficacy | Post 2 (day 32) | 4.36 units on a scale | Standard Deviation 0.98 |
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.
Time frame: days 16 and 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Constituent Message With FDA and Quitline | Self Efficacy | Post 1 (Day 16) | 2.83 units on a scale | Standard Deviation 1.13 |
| Constituent Message With FDA and Quitline | Self Efficacy | Post 2 (Day 32) | 2.98 units on a scale | Standard Deviation 1.23 |
| Constituent Message Without FDA and Quitline | Self Efficacy | Post 1 (Day 16) | 2.84 units on a scale | Standard Deviation 1.08 |
| Constituent Message Without FDA and Quitline | Self Efficacy | Post 2 (Day 32) | 2.95 units on a scale | Standard Deviation 1.18 |
| Littering Message (Control) | Self Efficacy | Post 1 (Day 16) | 2.69 units on a scale | Standard Deviation 1.1 |
| Littering Message (Control) | Self Efficacy | Post 2 (Day 32) | 2.89 units on a scale | Standard Deviation 1.11 |
Secondary
Use of Quitline During the Study
Measured by survey
Time frame: days 16 and 32
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Constituent Message With FDA and Quitline | Use of Quitline During the Study | Reported calling Quitline at post 1 (day 16) | 9 Participants |
| Constituent Message With FDA and Quitline | Use of Quitline During the Study | Reported calling Quitline at post 2 (day 32) | 23 Participants |
| Constituent Message Without FDA and Quitline | Use of Quitline During the Study | Reported calling Quitline at post 1 (day 16) | 7 Participants |
| Constituent Message Without FDA and Quitline | Use of Quitline During the Study | Reported calling Quitline at post 2 (day 32) | 21 Participants |
| Littering Message (Control) | Use of Quitline During the Study | Reported calling Quitline at post 1 (day 16) | 8 Participants |
| Littering Message (Control) | Use of Quitline During the Study | Reported calling Quitline at post 2 (day 32) | 16 Participants |