Smoking Cessation
Conditions
Brief summary
This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts & pictorial HWLs. Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group. Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches. The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.
Interventions
OTHERInserts with efficacy messages
Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.
OTHERPictorial warnings on packs
Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.
Sponsors
Cornell University
University of Waterloo
University of Tasmania
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
In a 2 X 2 between subject design, smokers will be randomized into one of four cigarette package labeling conditions: 1. no inserts or pictorial HWLs; 2. inserts only; 3. pictorial HWLs only; 4. inserts & pictorial HWLs
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 or older * Have smoked at least 100 cigarettes in their lifetime * Smoked at least 10 cigarettes a day in the prior month.
Exclusion criteria
* Use of other nicotine products besides cigarettes in the prior month. * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Talk About Smoking Cessation | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | For each day, a single binary variable was derived to indicate whether the participant talked about either smoking cessation or smoking-related harms in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event of talking about cessation or harms is a better outcome, as it is a predictor of cessation attempts. |
| Foregoing a Cigarette | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | For each day, responses to two questions were combined to create a binary variable for whether, in the prior 24 hours, the participant a) did not smoke a cigarette when they normally would, and/or b) stubbed out a cigarette before finishing it, with the average daily percentage of this outcome estimated. Experiencing the event of forgoing/stubbing out is a better outcome, as it is a predictor of cessation attempts. |
| Self-efficacy to Quit Smoking | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | A single question measured on a continuous scale (1=Not at all, worse outcome; 7=Extremely, better outcome) to assess strength of confidence to quit smoking, with average scores (range 1-7) estimated. |
| Self-efficacy to Cut Down on Smoking | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | A single question measured on a continuous scale (1=Not at all, worse outcome; 7=Extremely, better outcome) to assess strength of confidence to cut down on the number of cigarettes smoked, with average scores (range=1-7) estimated. |
| Worry About Harms From Smoking | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | A single question measured on a continuous scale to assess strength of worry about harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range=1-7) estimated. |
| Strength of Feeling About Smoking | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | A single question measured on a continuous scale to assess strength of positive to negative feelings about smoking (1=very bad, better outcome; 7=very good, worse outcome), with average scores (range=1-7) estimated |
| Extent of Motivation to Quit Smoking | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | A single question measured on a continuous scale to assess the extent of motivation to quit smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range=1-7) estimated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expressed Reactance Against Health Messages | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | a. Binary measure for whether the participant reported talking about how health information on packs is either useless or not believable in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event is a worse outcome, as it suggests defensive responding to labels. |
| Cigarettes Logged | Participants logged each cigarette smoked over the 14 day study period, with analyses limited to reports from days 2-14. Day 1 and 15 were dropped due to varying coverage of the day depending on study orientation time (Day 1) and ending (Day 15). | Continuous variable summing the total number of cigarettes logged over the study period. Lower values represent a better outcome (i.e., fewer cigarettes smoked). |
| Satisfaction From Smoking | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | Single question measured on a continuous scale that assesses strength of satisfaction from smoking (1=Not at all, better outcome; 7=Extremely, worse outcome), with average scores (range 1-7) estimated. |
| Strength of Hopefulness About Quitting | Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time. | A single question measured on a continuous scale to assess strength of feeling hopeful about quitting (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated. |
| Extent of Cognitive Elaboration of Smoking Benefits | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | A single question measured on a continuous scale to assess the frequency of thinking about the positive things about smoking (1=Not at all, better outcome; 7=Extremely, worse outcome), with average scores (range 1-7) estimated. |
| Extent of Cognitive Elaboration of Smoking Harms | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | A single question measured on a continuous scale to assess the frequency of thinking about the harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated. |
| Extent of Cognitive Elaboration of Cessation Benefits | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | A single question measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated. |
| Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy) | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | A single question measured on a continuous scale to assess the strength of perceived benefits from cessation (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated. |
| Strength of Perceived Susceptibility to Smoking Harms | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | A single question measured on a continuous scale to assess the perceived likelihood of suffering harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Conversation Partners | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | Nominal variable indicating the types of people with whom people talked about smoking and cessation in the prior 24 hours |
| Conversation Topics | Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time. | Nominal variable indicating the topics of conversation around smoking in the prior 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Cigarette Packs (Control) Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with the only alteration being the small health warning message on the side of the pack, whose textual content will be the same as that used for the pictorial warning label conditions. | 101 |
| Cigarette Packs With Inserts Only Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four different rotating messages to promote response efficacy beliefs (2 inserts on the benefits of cessation) or self-efficacy to quit (2 inserts with cessation tips).
Inserts with efficacy messages: Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs. | 87 |
| Cigarette Packs With Pictorial Warnings Only Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include four different rotating pictorial warnings showing the consequences of smoking and that cover 50% of the front and back of the pack.
Pictorial warnings on packs: Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs. | 90 |
| Cigarette Packs With Inserts and Pictorial Warnings Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four rotating efficacy messages (see description above) and four rotating pictorial warnings (see above).
Inserts with efficacy messages: Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.
Pictorial warnings on packs: Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs. | 89 |
| Total | 367 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost study phone the first day of study participation | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 5 | 2 | 2 |
| Overall Study | Not literate enough to self-administer study surveys | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Cigarette Packs (Control) | Cigarette Packs With Inserts Only | Cigarette Packs With Pictorial Warnings Only | Cigarette Packs With Inserts and Pictorial Warnings | Total |
|---|---|---|---|---|---|
| Age, Customized 18-35 years old | 27 Participants | 27 Participants | 26 Participants | 21 Participants | 101 Participants |
| Age, Customized 36-55 years old | 54 Participants | 42 Participants | 46 Participants | 49 Participants | 191 Participants |
| Age, Customized 56 years old and older | 20 Participants | 18 Participants | 18 Participants | 19 Participants | 75 Participants |
| Delayed Discounting | 0.56 units on a scale STANDARD_DEVIATION 3.37 | 0.40 units on a scale STANDARD_DEVIATION 2.7 | 0.36 units on a scale STANDARD_DEVIATION 2.56 | 0.60 units on a scale STANDARD_DEVIATION 3.57 | 0.48 units on a scale STANDARD_DEVIATION 3.08 |
| Educational Attainment Greater than High School Education | 53 participants | 49 participants | 57 participants | 50 participants | 209 participants |
| Educational Attainment High School Education or less | 48 participants | 36 participants | 30 participants | 39 participants | 153 participants |
| Educational Attainment Missing | 0 participants | 2 participants | 3 participants | 0 participants | 5 participants |
| Health Literacy Adequate | 66 participants | 61 participants | 66 participants | 63 participants | 256 participants |
| Health Literacy Limited OR Possibly Limited | 35 participants | 26 participants | 24 participants | 26 participants | 111 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 8 Participants | 8 Participants | 14 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) White | 75 Participants | 74 Participants | 73 Participants | 71 Participants | 293 Participants |
| Region of Enrollment United States | 101 participants | 87 participants | 90 participants | 89 participants | 367 participants |
| Self-efficacy to quit smoking | 2.32 units on a scale STANDARD_DEVIATION 1.06 | 2.30 units on a scale STANDARD_DEVIATION 0.92 | 2.39 units on a scale STANDARD_DEVIATION 1.05 | 2.21 units on a scale STANDARD_DEVIATION 0.81 | 2.31 units on a scale STANDARD_DEVIATION 0.97 |
| Sex: Female, Male Sex Female | 60 Participants | 52 Participants | 52 Participants | 61 Participants | 225 Participants |
| Sex: Female, Male Sex Male | 41 Participants | 35 Participants | 38 Participants | 28 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 94 | 0 / 94 | 0 / 91 |
| other Total, other adverse events | 0 / 108 | 0 / 94 | 0 / 94 | 0 / 91 |
| serious Total, serious adverse events | 0 / 108 | 1 / 94 | 1 / 94 | 0 / 91 |
Outcome results
Primary
Extent of Motivation to Quit Smoking
A single question measured on a continuous scale to assess the extent of motivation to quit smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range=1-7) estimated.
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations from daily cigarette surveys. Due to missing data on moderators, the analytic sample differs for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) and for each H6 moderating variable: education (n=101, 84, 87, and 88, respectively); health literacy (n=101, 86, 90, and 88, respectively); and delayed discounting (n=101, 84, 88, and 88, respectively).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Extent of Motivation to Quit Smoking | 3.63 score on a scale | Standard Deviation 1.64 |
| Cigarette Packs With Inserts Only | Extent of Motivation to Quit Smoking | 4.00 score on a scale | Standard Deviation 1.76 |
| Cigarette Packs With Pictorial Warnings Only | Extent of Motivation to Quit Smoking | 3.76 score on a scale | Standard Deviation 1.79 |
| Cigarette Packs With Inserts and Pictorial Warnings | Extent of Motivation to Quit Smoking | 3.62 score on a scale | Standard Deviation 1.74 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.4595% CI: [-0.69, 1.57]Mixed Models Analysis
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.4195% CI: [-1.61, 0.66]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.0895% CI: [-3.08, 0.2]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.5295% CI: [-2.14, 1.09]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.7595% CI: [-1.82, 2.51]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.6495% CI: [-3.82, 2.33]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.9195% CI: [-2.17, 2.45]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.595% CI: [-3.29, 1.6]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.00795% CI: [0.86, 5.41]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.5295% CI: [-2.22, 4.4]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.8695% CI: [-3.89, 3.23]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.6195% CI: [-4.15, 2.43]Mixed Models Analysis
Primary
Foregoing a Cigarette
For each day, responses to two questions were combined to create a binary variable for whether, in the prior 24 hours, the participant a) did not smoke a cigarette when they normally would, and/or b) stubbed out a cigarette before finishing it, with the average daily percentage of this outcome estimated. Experiencing the event of forgoing/stubbing out is a better outcome, as it is a predictor of cessation attempts.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations from evening reports. Due to missing data on moderators, the analytic sample differs for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) and for each H6 moderating variable: education (n=101, 85, 87, and 88, respectively); health literacy (n=101, 87, 90, and 88, respectively); and delayed discounting (n=101, 85, 88, and 88, respectively).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Foregoing a Cigarette | 0.3882 percentage of days (events/days) | Standard Error 0.4876 |
| Cigarette Packs With Inserts Only | Foregoing a Cigarette | 0.5479 percentage of days (events/days) | Standard Error 0.498 |
| Cigarette Packs With Pictorial Warnings Only | Foregoing a Cigarette | 0.4916 percentage of days (events/days) | Standard Error 0.5002 |
| Cigarette Packs With Inserts and Pictorial Warnings | Foregoing a Cigarette | 0.5807 percentage of days (events/days) | Standard Error 0.4937 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.00195% CI: [1.42, 4.31]Mixed Models Analysis
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.02595% CI: [1.09, 3.3]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.4495% CI: [0.62, 3.06]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.1595% CI: [0.81, 3.97]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.7695% CI: [0.39, 3.58]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.7795% CI: [0.16, 3.8]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.1795% CI: [0.72, 6.61]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.2295% CI: [0.14, 1.57]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.0295% CI: [1.15, 10.37]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.0495% CI: [1.12, 26.53]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.5695% CI: [0.1, 3.47]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.4695% CI: [0.11, 2.68]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.000295% CI: [1.56, 4.27]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.013595% CI: [1.14, 3.12]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.261995% CI: [0.73, 3.12]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.047495% CI: [1.01, 4.24]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.809495% CI: [0.42, 3.07]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.797895% CI: [0.2, 3.44]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.101695% CI: [0.85, 6.15]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.15795% CI: [0.15, 1.36]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.029795% CI: [1.11, 8.18]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.021395% CI: [1.28, 21.73]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.964895% CI: [0.2, 4.74]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.6512Mixed Models Analysis
Primary
Self-efficacy to Cut Down on Smoking
A single question measured on a continuous scale (1=Not at all, worse outcome; 7=Extremely, better outcome) to assess strength of confidence to cut down on the number of cigarettes smoked, with average scores (range=1-7) estimated.
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations from daily cigarette surveys. Analytic samples for H6 differ due to some missing data for each moderating variable: education (control=101; insert only=84; pictorial warnings only=87; insert + pictorial warnings=88); health literacy (control=101; insert only=86; pictorial warnings only=90; insert + pictorial warnings=88); and delayed discounting (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Self-efficacy to Cut Down on Smoking | 3.15 score on a scale | Standard Deviation 1.42 |
| Cigarette Packs With Inserts Only | Self-efficacy to Cut Down on Smoking | 3.52 score on a scale | Standard Deviation 1.59 |
| Cigarette Packs With Pictorial Warnings Only | Self-efficacy to Cut Down on Smoking | 3.29 score on a scale | Standard Deviation 1.51 |
| Cigarette Packs With Inserts and Pictorial Warnings | Self-efficacy to Cut Down on Smoking | 3.18 score on a scale | Standard Deviation 1.56 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.5795% CI: [-0.68, 1.24]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.0895% CI: [-2.63, 0.14]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment, comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.3995% CI: [-1.97, 0.77]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.6195% CI: [-1.45, 2.47]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.995% CI: [-2.23, 1.97]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.0495% CI: [0.13, 3.97]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.6495% CI: [-2.14, 3.48]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.9295% CI: [-2.91, 3.2]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.1195% CI: [-5.02, 0.52]Mixed Models Analysis
Primary
Self-efficacy to Quit Smoking
A single question measured on a continuous scale (1=Not at all, worse outcome; 7=Extremely, better outcome) to assess strength of confidence to quit smoking, with average scores (range 1-7) estimated.
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations from daily cigarette surveys. Analytic samples for H6 differ due to some missing data for each moderating variable: education (control=101; insert only=84; pictorial warnings only=87; insert + pictorial warnings=88); health literacy (control=101; insert only=86; pictorial warnings only=90; insert + pictorial warnings=88); and delayed discounting (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Self-efficacy to Quit Smoking | 2.61 score on a scale | Standard Deviation 1.44 |
| Cigarette Packs With Inserts Only | Self-efficacy to Quit Smoking | 2.76 score on a scale | Standard Deviation 1.55 |
| Cigarette Packs With Pictorial Warnings Only | Self-efficacy to Quit Smoking | 2.62 score on a scale | Standard Deviation 1.52 |
| Cigarette Packs With Inserts and Pictorial Warnings | Self-efficacy to Quit Smoking | 2.56 score on a scale | Standard Deviation 1.4 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.695% CI: [-0.73, 1.25]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.2995% CI: [-2.22, 0.66]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.7395% CI: [-1.67, 1.16]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.7795% CI: [-2.34, 1.74]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.5195% CI: [-1.43, 2.88]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.0595% CI: [0.02, 4.01]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.5495% CI: [-3.84, 2.02]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.2195% CI: [-1.13, 5.17]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.4795% CI: [-3.97, 1.83]Mixed Models Analysis
Primary
Strength of Feeling About Smoking
A single question measured on a continuous scale to assess strength of positive to negative feelings about smoking (1=very bad, better outcome; 7=very good, worse outcome), with average scores (range=1-7) estimated
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations collected from daily cigarette surveys. The number of participants in the analytic sample is slightly smaller for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) due to missing data from the baseline survey that provides information for the moderating variables.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Strength of Feeling About Smoking | 3.98 score on a scale | Standard Deviation 1.77 |
| Cigarette Packs With Inserts Only | Strength of Feeling About Smoking | 3.75 score on a scale | Standard Deviation 1.6 |
| Cigarette Packs With Pictorial Warnings Only | Strength of Feeling About Smoking | 3.71 score on a scale | Standard Deviation 1.65 |
| Cigarette Packs With Inserts and Pictorial Warnings | Strength of Feeling About Smoking | 3.85 score on a scale | Standard Deviation 1.67 |
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.495% CI: [-1.33, 0.53]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial health warning labels (HWLs) (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.9995% CI: [-1.83, 1.86]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.1795% CI: [-0.78, 4.48]Mixed Models Analysis
Primary
Talk About Smoking Cessation
For each day, a single binary variable was derived to indicate whether the participant talked about either smoking cessation or smoking-related harms in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event of talking about cessation or harms is a better outcome, as it is a predictor of cessation attempts.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations from evening reports. Due to missing data on moderators, the analytic sample differs for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) and for each H6 moderating variable: education (n=101, 85, 87, and 88, respectively); health literacy (n=101, 87, 90, and 88, respectively); and delayed discounting (n=101, 85, 88, and 88, respectively).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Talk About Smoking Cessation | 0.1589 percentage of days (events/days) | Standard Deviation 0.3658 |
| Cigarette Packs With Inserts Only | Talk About Smoking Cessation | 0.1645 percentage of days (events/days) | Standard Deviation 0.3709 |
| Cigarette Packs With Pictorial Warnings Only | Talk About Smoking Cessation | 0.1833 percentage of days (events/days) | Standard Deviation 0.3871 |
| Cigarette Packs With Inserts and Pictorial Warnings | Talk About Smoking Cessation | 0.1898 percentage of days (events/days) | Standard Deviation 0.3924 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.2995% CI: [0.82, 1.96]Mixed Models Analysis
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.4395% CI: [0.77, 1.85]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.695% CI: [0.63, 2.2]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.4895% CI: [0.67, 2.33]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.6295% CI: [0.34, 1.91]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.07995% CI: [0.88, 10.52]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.195% CI: [0.87, 5.12]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.5295% CI: [0.52, 3.61]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.5495% CI: [0.55, 3.17]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.3395% CI: [0.53, 6.61]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.5595% CI: [0.38, 6.11]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.4495% CI: [0.18, 2.14]Mixed Models Analysis
Comparison: These results are for the multiple imputation models for pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.25195% CI: [0.84, 1.98]Mixed Models Analysis
Comparison: These results are for the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.282295% CI: [0.82, 1.95]Mixed Models Analysis
Comparison: These results are for multiple imputation models for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.355895% CI: [0.72, 2.47]Mixed Models Analysis
Comparison: These results are for the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.329195% CI: [0.73, 2.51]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.781895% CI: [0.38, 2.09]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.091295% CI: [0.84, 9.73]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.136195% CI: [0.81, 4.66]Mixed Models Analysis
Comparison: These results are for the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.7295% CI: [0.46, 3.07]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.373795% CI: [0.62, 3.53]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.134595% CI: [0.75, 8.9]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.331895% CI: [0.5, 7.67]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.701795% CI: [0.23, 2.7]Mixed Models Analysis
Primary
Worry About Harms From Smoking
A single question measured on a continuous scale to assess strength of worry about harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range=1-7) estimated.
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations collected from daily cigarette surveys. The number of participants in the analytic sample is slightly smaller for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) due to missing data from the baseline survey that provides information for the moderating variables.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Worry About Harms From Smoking | 4.34 score on a scale | Standard Deviation 1.94 |
| Cigarette Packs With Inserts Only | Worry About Harms From Smoking | 4.84 score on a scale | Standard Deviation 1.74 |
| Cigarette Packs With Pictorial Warnings Only | Worry About Harms From Smoking | 4.46 score on a scale | Standard Deviation 1.91 |
| Cigarette Packs With Inserts and Pictorial Warnings | Worry About Harms From Smoking | 4.47 score on a scale | Standard Deviation 1.75 |
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.5795% CI: [-1.48, 0.82]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial warnings (averaged over insert) vs no pictorial warnings (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)p-value: 0.3995% CI: [-3.22, 1.27]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.9295% CI: [-3.35, 3.04]Mixed Models Analysis
Secondary
Cigarettes Logged
Continuous variable summing the total number of cigarettes logged over the study period. Lower values represent a better outcome (i.e., fewer cigarettes smoked).
Time frame: Participants logged each cigarette smoked over the 14 day study period, with analyses limited to reports from days 2-14. Day 1 and 15 were dropped due to varying coverage of the day depending on study orientation time (Day 1) and ending (Day 15).
Population: Analyses assess the sum of all cigarettes participants logged from days 2-14 of the study. Due to missing data on moderators, the analytic sample differs for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) and for each H6 moderating variable: education (n=101, 85, 87, and 88, respectively); health literacy (n=101, 87, 90, and 88, respectively); and delayed discounting (n=101, 85, 88, and 88, respectively).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Cigarettes Logged | 181.1 cigarettes | Standard Deviation 81.9 |
| Cigarette Packs With Inserts Only | Cigarettes Logged | 185.9 cigarettes | Standard Deviation 95.85 |
| Cigarette Packs With Pictorial Warnings Only | Cigarettes Logged | 190.3 cigarettes | Standard Deviation 103 |
| Cigarette Packs With Inserts and Pictorial Warnings | Cigarettes Logged | 185.8 cigarettes | Standard Deviation 97.42 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.9295% CI: [0.9, 1.1]Negative binomial regression
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.9595% CI: [0.9, 1.11]Negative binomial regression
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.8595% CI: [0.85, 1.14]Negative binomial regression
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.7595% CI: [0.84, 1.13]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)p-value: 0.7895% CI: [0.78, 1.2]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.1195% CI: [0.94, 1.82]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.9395% CI: [0.8, 1.22]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.8695% CI: [0.78, 1.23]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.9495% CI: [0.81, 1.22]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.1395% CI: [0.93, 1.78]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.9695% CI: [0.7, 1.41]Negative binomial regression
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.9595% CI: [0.72, 1.36]Negative binomial regression
Secondary
Expressed Reactance Against Health Messages
a. Binary measure for whether the participant reported talking about how health information on packs is either useless or not believable in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event is a worse outcome, as it suggests defensive responding to labels.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations collected from daily cigarette surveys or evening reports, depending on the outcome. The number of participants in the analytic sample is slightly smaller for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) due to missing data from the baseline survey that provides information for the moderating variables.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Expressed Reactance Against Health Messages | 0.0103 percentage of days (events/days) | Standard Deviation 0.1011 |
| Cigarette Packs With Inserts Only | Expressed Reactance Against Health Messages | 0.0194 percentage of days (events/days) | Standard Deviation 0.138 |
| Cigarette Packs With Pictorial Warnings Only | Expressed Reactance Against Health Messages | 0.0369 percentage of days (events/days) | Standard Deviation 0.1885 |
| Cigarette Packs With Inserts and Pictorial Warnings | Expressed Reactance Against Health Messages | 0.0157 percentage of days (events/days) | Standard Deviation 0.1242 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.p-value: 0.8395% CI: [0.45, 2.7]Mixed Models Analysis
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.0395% CI: [1.14, 7.18]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.1895% CI: [0.15, 1.44]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.9995% CI: [0.08, 12.57]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.8695% CI: [0.29, 2.82]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.p-value: 0.8045Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.0205Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.1918Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.99Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.6873Mixed Models Analysis
Secondary
Extent of Cognitive Elaboration of Cessation Benefits
A single question measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations from evening reports. Analytic samples for H6 differ due to some missing data for each moderating variable: education (control=101; insert only=84; pictorial warnings only=87; insert + pictorial warnings=88); health literacy (control=101; insert only=86; pictorial warnings only=90; insert + pictorial warnings=88); and delayed discounting (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Extent of Cognitive Elaboration of Cessation Benefits | 4.07 score on a scale | Standard Deviation 1.81 |
| Cigarette Packs With Inserts Only | Extent of Cognitive Elaboration of Cessation Benefits | 4.62 score on a scale | Standard Deviation 1.77 |
| Cigarette Packs With Pictorial Warnings Only | Extent of Cognitive Elaboration of Cessation Benefits | 4.13 score on a scale | Standard Deviation 1.9 |
| Cigarette Packs With Inserts and Pictorial Warnings | Extent of Cognitive Elaboration of Cessation Benefits | 4.34 score on a scale | Standard Deviation 1.77 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.0495% CI: [0.02, 1.37]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.0895% CI: [-1.85, 0.11]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.6595% CI: [-0.74, 1.19]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.395% CI: [-0.66, 2.11]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.7895% CI: [-1.68, 1.26]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.0395% CI: [0.12, 2.83]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.9595% CI: [-1.92, 2.04]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.4895% CI: [-2.91, 1.36]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.3795% CI: [-2.86, 1.07]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.019295% CI: [0.12, 1.34]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.18695% CI: [-1.48, 0.29]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.386395% CI: [-0.49, 1.26]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.57195% CI: [-0.89, 1.61]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.279795% CI: [-2.06, 0.6]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.031295% CI: [0.12, 2.55]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.508695% CI: [-1.19, 2.39]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.947495% CI: [-1.86, 1.99]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.501895% CI: [-2.36, 1.16]Mixed Models Analysis
Secondary
Extent of Cognitive Elaboration of Smoking Benefits
A single question measured on a continuous scale to assess the frequency of thinking about the positive things about smoking (1=Not at all, better outcome; 7=Extremely, worse outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations collected from evening surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Extent of Cognitive Elaboration of Smoking Benefits | 3.19 score on a scale | Standard Deviation 1.72 |
| Cigarette Packs With Inserts Only | Extent of Cognitive Elaboration of Smoking Benefits | 3.20 score on a scale | Standard Deviation 1.64 |
| Cigarette Packs With Pictorial Warnings Only | Extent of Cognitive Elaboration of Smoking Benefits | 3.16 score on a scale | Standard Deviation 1.69 |
| Cigarette Packs With Inserts and Pictorial Warnings | Extent of Cognitive Elaboration of Smoking Benefits | 3.17 score on a scale | Standard Deviation 1.7 |
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.4595% CI: [-0.81, 0.36]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.576795% CI: [-0.64, 0.7]Mixed Models Analysis
Secondary
Extent of Cognitive Elaboration of Smoking Harms
A single question measured on a continuous scale to assess the frequency of thinking about the harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations collected from daily cigarette surveys or evening reports, depending on the outcome. The number of participants in the analytic sample is slightly smaller for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) due to missing data from the baseline survey that provides information for the moderating variables.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Extent of Cognitive Elaboration of Smoking Harms | 3.91 score on a scale | Standard Deviation 1.83 |
| Cigarette Packs With Inserts Only | Extent of Cognitive Elaboration of Smoking Harms | 4.40 score on a scale | Standard Deviation 1.77 |
| Cigarette Packs With Pictorial Warnings Only | Extent of Cognitive Elaboration of Smoking Harms | 3.95 score on a scale | Standard Deviation 1.89 |
| Cigarette Packs With Inserts and Pictorial Warnings | Extent of Cognitive Elaboration of Smoking Harms | 4.15 score on a scale | Standard Deviation 1.77 |
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.3695% CI: [-0.98, 0.36]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.6395% CI: [-1.64, 0.99]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.7995% CI: [-1.62, 2.12]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.449195% CI: [-0.84, 0.37]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).p-value: 0.871395% CI: [-1.26, 1.06]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.9995% CI: [-1.66, 1.66]Mixed Models Analysis
Secondary
Satisfaction From Smoking
Single question measured on a continuous scale that assesses strength of satisfaction from smoking (1=Not at all, better outcome; 7=Extremely, worse outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations collected from daily cigarette surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Satisfaction From Smoking | 4.95 score on a scale | Standard Deviation 1.47 |
| Cigarette Packs With Inserts Only | Satisfaction From Smoking | 4.89 score on a scale | Standard Deviation 1.43 |
| Cigarette Packs With Pictorial Warnings Only | Satisfaction From Smoking | 4.74 score on a scale | Standard Deviation 1.56 |
| Cigarette Packs With Inserts and Pictorial Warnings | Satisfaction From Smoking | 4.83 score on a scale | Standard Deviation 1.45 |
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.3795% CI: [-1.12, 0.41]Mixed Models Analysis
Secondary
Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy)
A single question measured on a continuous scale to assess the strength of perceived benefits from cessation (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations from evening reports. Analytic samples for H6 differ due to some missing data for each moderating variable: education (control=101; insert only=84; pictorial warnings only=87; insert + pictorial warnings=88); health literacy (control=101; insert only=86; pictorial warnings only=90; insert + pictorial warnings=88); and delayed discounting (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy) | 4.69 Score on a scale | Standard Deviation 1.87 |
| Cigarette Packs With Inserts Only | Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy) | 5.18 Score on a scale | Standard Deviation 1.51 |
| Cigarette Packs With Pictorial Warnings Only | Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy) | 4.96 Score on a scale | Standard Deviation 1.78 |
| Cigarette Packs With Inserts and Pictorial Warnings | Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy) | 4.95 Score on a scale | Standard Deviation 1.65 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.2595% CI: [-0.31, 1.21]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.3495% CI: [-1.63, 0.57]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.7695% CI: [-1.26, 0.92]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.1595% CI: [-0.42, 2.63]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 195% CI: [-1.66, 1.66]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.0195% CI: [0.38, 3.43]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.5895% CI: [-1.56, 2.8]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.3995% CI: [-3.47, 1.35]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.4595% CI: [-3.05, 1.35]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.114795% CI: [-0.13, 1.21]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.372195% CI: [-1.41, 0.53]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.882795% CI: [-0.89, 1.03]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.433595% CI: [-0.8, 1.87]Mixed Models Analysis
Comparison: These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.406395% CI: [-2.07, 0.84]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.013295% CI: [0.35, 3.03]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.394995% CI: [-1.08, 2.75]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.714595% CI: [-2.5, 1.72]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.6081Mixed Models Analysis
Secondary
Strength of Hopefulness About Quitting
A single question measured on a continuous scale to assess strength of feeling hopeful about quitting (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Population: Analyses include repeated observations from daily cigarette surveys. Analytic samples for H6 differ due to some missing data for each moderating variable: education (control=101; insert only=84; pictorial warnings only=87; insert + pictorial warnings=88); health literacy (control=101; insert only=86; pictorial warnings only=90; insert + pictorial warnings=88); and delayed discounting (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Strength of Hopefulness About Quitting | 3.80 score on a scale | Standard Deviation 1.8 |
| Cigarette Packs With Inserts Only | Strength of Hopefulness About Quitting | 4.25 score on a scale | Standard Deviation 1.91 |
| Cigarette Packs With Pictorial Warnings Only | Strength of Hopefulness About Quitting | 3.96 score on a scale | Standard Deviation 1.87 |
| Cigarette Packs With Inserts and Pictorial Warnings | Strength of Hopefulness About Quitting | 3.86 score on a scale | Standard Deviation 1.889 |
Comparison: These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.p-value: 0.4195% CI: [-0.75, 1.85]Mixed Models Analysis
Comparison: These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.p-value: 0.0895% CI: [-3.55, 0.21]Mixed Models Analysis
Comparison: These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.p-value: 0.5595% CI: [-2.42, 1.29]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).p-value: 0.3895% CI: [-1.47, 3.86]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).p-value: 0.7195% CI: [-3.35, 2.28]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).p-value: 0.0295% CI: [0.59, 5.83]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.9895% CI: [-3.85, 3.76]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.3195% CI: [-6.2, 1.95]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).p-value: 0.6895% CI: [-4.58, 2.97]Mixed Models Analysis
Secondary
Strength of Perceived Susceptibility to Smoking Harms
A single question measured on a continuous scale to assess the perceived likelihood of suffering harms from smoking (1=Not at all, worse outcome; 7=Extremely, better outcome), with average scores (range 1-7) estimated.
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Population: Analyses include repeated observations collected from evening reports. The number of participants in the analytic sample is slightly smaller for H5 (control=101; insert only=84; pictorial warnings only=88; insert + pictorial warnings=88) due to missing data from the baseline survey that provides information for the moderating variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cigarette Packs (Control) | Strength of Perceived Susceptibility to Smoking Harms | 4.95 score on a scale | Standard Deviation 1.81 |
| Cigarette Packs With Inserts Only | Strength of Perceived Susceptibility to Smoking Harms | 5.53 score on a scale | Standard Deviation 1.42 |
| Cigarette Packs With Pictorial Warnings Only | Strength of Perceived Susceptibility to Smoking Harms | 5.21 score on a scale | Standard Deviation 1.76 |
| Cigarette Packs With Inserts and Pictorial Warnings | Strength of Perceived Susceptibility to Smoking Harms | 5.21 score on a scale | Standard Deviation 1.61 |
Comparison: These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.5895% CI: [-1.15, 0.64]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)p-value: 0.8295% CI: [-1.98, 1.57]Mixed Models Analysis
Comparison: These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.295% CI: [-0.9, 4.24]Mixed Models Analysis
Comparison: These results from the multiple imputation analysis are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.p-value: 0.8895% CI: [-0.77, 0.66]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)p-value: 0.886495% CI: [-1.3, 1.5]Mixed Models Analysis
Comparison: These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).p-value: 0.274895% CI: [-0.89, 3.12]Mixed Models Analysis
Other Pre-specified
Conversation Partners
Nominal variable indicating the types of people with whom people talked about smoking and cessation in the prior 24 hours
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Other Pre-specified
Conversation Topics
Nominal variable indicating the topics of conversation around smoking in the prior 24 hours
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.