Trial Outcomes & Findings for Cigarette Pack Inserts for Smoking Cessation (NCT NCT04075682)
NCT ID: NCT04075682
Last Updated: 2024-05-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
387 participants
Primary outcome timeframe
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.
Results posted on
2024-05-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
108
|
94
|
94
|
91
|
|
Overall Study
COMPLETED
|
101
|
87
|
90
|
89
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Overall Study
Not literate enough to self-administer study surveys
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost study phone the first day of study participation
|
0
|
1
|
0
|
0
|
Baseline Characteristics
This 3-item scale with Likert response options was averaged across the three items and has a range of 1-5, where higher values represent a better outcome (i.e., greater confidence to quit smoking).
Baseline characteristics by cohort
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
Total
n=367 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-35 years old
|
27 Participants
n=101 Participants
|
27 Participants
n=87 Participants
|
26 Participants
n=90 Participants
|
21 Participants
n=89 Participants
|
101 Participants
n=367 Participants
|
|
Age, Customized
36-55 years old
|
54 Participants
n=101 Participants
|
42 Participants
n=87 Participants
|
46 Participants
n=90 Participants
|
49 Participants
n=89 Participants
|
191 Participants
n=367 Participants
|
|
Age, Customized
56 years old and older
|
20 Participants
n=101 Participants
|
18 Participants
n=87 Participants
|
18 Participants
n=90 Participants
|
19 Participants
n=89 Participants
|
75 Participants
n=367 Participants
|
|
Sex: Female, Male
Sex · Female
|
60 Participants
n=101 Participants
|
52 Participants
n=87 Participants
|
52 Participants
n=90 Participants
|
61 Participants
n=89 Participants
|
225 Participants
n=367 Participants
|
|
Sex: Female, Male
Sex · Male
|
41 Participants
n=101 Participants
|
35 Participants
n=87 Participants
|
38 Participants
n=90 Participants
|
28 Participants
n=89 Participants
|
142 Participants
n=367 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=101 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=90 Participants
|
1 Participants
n=89 Participants
|
4 Participants
n=367 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=101 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=90 Participants
|
0 Participants
n=89 Participants
|
2 Participants
n=367 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=101 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=90 Participants
|
0 Participants
n=89 Participants
|
1 Participants
n=367 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=101 Participants
|
8 Participants
n=87 Participants
|
8 Participants
n=90 Participants
|
14 Participants
n=89 Participants
|
47 Participants
n=367 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=101 Participants
|
74 Participants
n=87 Participants
|
73 Participants
n=90 Participants
|
71 Participants
n=89 Participants
|
293 Participants
n=367 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=101 Participants
|
2 Participants
n=87 Participants
|
3 Participants
n=90 Participants
|
1 Participants
n=89 Participants
|
8 Participants
n=367 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=101 Participants
|
2 Participants
n=87 Participants
|
4 Participants
n=90 Participants
|
2 Participants
n=89 Participants
|
12 Participants
n=367 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=101 Participants
|
87 participants
n=87 Participants
|
90 participants
n=90 Participants
|
89 participants
n=89 Participants
|
367 participants
n=367 Participants
|
|
Educational Attainment
High School Education or less
|
48 participants
n=101 Participants
|
36 participants
n=87 Participants
|
30 participants
n=90 Participants
|
39 participants
n=89 Participants
|
153 participants
n=367 Participants
|
|
Educational Attainment
Greater than High School Education
|
53 participants
n=101 Participants
|
49 participants
n=87 Participants
|
57 participants
n=90 Participants
|
50 participants
n=89 Participants
|
209 participants
n=367 Participants
|
|
Educational Attainment
Missing
|
0 participants
n=101 Participants
|
2 participants
n=87 Participants
|
3 participants
n=90 Participants
|
0 participants
n=89 Participants
|
5 participants
n=367 Participants
|
|
Health Literacy
Adequate
|
66 participants
n=101 Participants
|
61 participants
n=87 Participants
|
66 participants
n=90 Participants
|
63 participants
n=89 Participants
|
256 participants
n=367 Participants
|
|
Health Literacy
Limited OR Possibly Limited
|
35 participants
n=101 Participants
|
26 participants
n=87 Participants
|
24 participants
n=90 Participants
|
26 participants
n=89 Participants
|
111 participants
n=367 Participants
|
|
Self-efficacy to quit smoking
|
2.32 units on a scale
STANDARD_DEVIATION 1.06 • n=100 Participants • This 3-item scale with Likert response options was averaged across the three items and has a range of 1-5, where higher values represent a better outcome (i.e., greater confidence to quit smoking).
|
2.30 units on a scale
STANDARD_DEVIATION 0.92 • n=83 Participants • This 3-item scale with Likert response options was averaged across the three items and has a range of 1-5, where higher values represent a better outcome (i.e., greater confidence to quit smoking).
|
2.39 units on a scale
STANDARD_DEVIATION 1.05 • n=88 Participants • This 3-item scale with Likert response options was averaged across the three items and has a range of 1-5, where higher values represent a better outcome (i.e., greater confidence to quit smoking).
|
2.21 units on a scale
STANDARD_DEVIATION 0.81 • n=88 Participants • This 3-item scale with Likert response options was averaged across the three items and has a range of 1-5, where higher values represent a better outcome (i.e., greater confidence to quit smoking).
|
2.31 units on a scale
STANDARD_DEVIATION 0.97 • n=359 Participants • This 3-item scale with Likert response options was averaged across the three items and has a range of 1-5, where higher values represent a better outcome (i.e., greater confidence to quit smoking).
|
|
Delayed Discounting
|
0.56 units on a scale
STANDARD_DEVIATION 3.37 • n=101 Participants
|
0.40 units on a scale
STANDARD_DEVIATION 2.70 • n=87 Participants
|
0.36 units on a scale
STANDARD_DEVIATION 2.56 • n=90 Participants
|
0.60 units on a scale
STANDARD_DEVIATION 3.57 • n=89 Participants
|
0.48 units on a scale
STANDARD_DEVIATION 3.08 • n=367 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Self-efficacy to Quit Smoking
|
2.61 score on a scale
Standard Deviation 1.44
|
2.76 score on a scale
Standard Deviation 1.55
|
2.62 score on a scale
Standard Deviation 1.52
|
2.56 score on a scale
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Self-efficacy to Cut Down on Smoking
|
3.15 score on a scale
Standard Deviation 1.42
|
3.52 score on a scale
Standard Deviation 1.59
|
3.29 score on a scale
Standard Deviation 1.51
|
3.18 score on a scale
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Worry About Harms From Smoking
|
4.34 score on a scale
Standard Deviation 1.94
|
4.84 score on a scale
Standard Deviation 1.74
|
4.46 score on a scale
Standard Deviation 1.91
|
4.47 score on a scale
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Strength of Feeling About Smoking
|
3.98 score on a scale
Standard Deviation 1.77
|
3.75 score on a scale
Standard Deviation 1.60
|
3.71 score on a scale
Standard Deviation 1.65
|
3.85 score on a scale
Standard Deviation 1.67
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Extent of Motivation to Quit Smoking
|
3.63 score on a scale
Standard Deviation 1.64
|
4.00 score on a scale
Standard Deviation 1.76
|
3.76 score on a scale
Standard Deviation 1.79
|
3.62 score on a scale
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=88 Participants
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.
|
|---|---|---|---|---|
|
Talk About Smoking Cessation
|
0.1589 percentage of days (events/days)
Standard Deviation 0.3658
|
0.1645 percentage of days (events/days)
Standard Deviation 0.3709
|
0.1833 percentage of days (events/days)
Standard Deviation 0.3871
|
0.1898 percentage of days (events/days)
Standard Deviation 0.3924
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=88 Participants
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.
|
|---|---|---|---|---|
|
Foregoing a Cigarette
|
0.3882 percentage of days (events/days)
Standard Error 0.4876
|
0.5479 percentage of days (events/days)
Standard Error 0.498
|
0.4916 percentage of days (events/days)
Standard Error 0.5002
|
0.5807 percentage of days (events/days)
Standard Error 0.4937
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Strength of Hopefulness About Quitting
|
3.80 score on a scale
Standard Deviation 1.80
|
4.25 score on a scale
Standard Deviation 1.91
|
3.96 score on a scale
Standard Deviation 1.87
|
3.86 score on a scale
Standard Deviation 1.889
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=89 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Extent of Cognitive Elaboration of Smoking Benefits
|
3.19 score on a scale
Standard Deviation 1.72
|
3.20 score on a scale
Standard Deviation 1.64
|
3.16 score on a scale
Standard Deviation 1.69
|
3.17 score on a scale
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=89 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Extent of Cognitive Elaboration of Smoking Harms
|
3.91 score on a scale
Standard Deviation 1.83
|
4.40 score on a scale
Standard Deviation 1.77
|
3.95 score on a scale
Standard Deviation 1.89
|
4.15 score on a scale
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=89 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Extent of Cognitive Elaboration of Cessation Benefits
|
4.07 score on a scale
Standard Deviation 1.81
|
4.62 score on a scale
Standard Deviation 1.77
|
4.13 score on a scale
Standard Deviation 1.90
|
4.34 score on a scale
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=89 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy)
|
4.69 Score on a scale
Standard Deviation 1.87
|
5.18 Score on a scale
Standard Deviation 1.51
|
4.96 Score on a scale
Standard Deviation 1.78
|
4.95 Score on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=89 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Strength of Perceived Susceptibility to Smoking Harms
|
4.95 score on a scale
Standard Deviation 1.81
|
5.53 score on a scale
Standard Deviation 1.42
|
5.21 score on a scale
Standard Deviation 1.76
|
5.21 score on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Expressed Reactance Against Health Messages
|
0.0103 percentage of days (events/days)
Standard Deviation 0.1011
|
0.0194 percentage of days (events/days)
Standard Deviation 0.1380
|
0.0369 percentage of days (events/days)
Standard Deviation 0.1885
|
0.0157 percentage of days (events/days)
Standard Deviation 0.1242
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=86 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Satisfaction From Smoking
|
4.95 score on a scale
Standard Deviation 1.47
|
4.89 score on a scale
Standard Deviation 1.43
|
4.74 score on a scale
Standard Deviation 1.56
|
4.83 score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 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).
Continuous variable summing the total number of cigarettes logged over the study period. Lower values represent a better outcome (i.e., fewer cigarettes smoked).
Outcome measures
| Measure |
Standard Cigarette Packs (Control)
n=101 Participants
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.
|
Cigarette Packs With Inserts Only
n=87 Participants
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.
|
Cigarette Packs With Pictorial Warnings Only
n=90 Participants
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=89 Participants
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.
|
|---|---|---|---|---|
|
Cigarettes Logged
|
181.1 cigarettes
Standard Deviation 81.90
|
185.9 cigarettes
Standard Deviation 95.85
|
190.3 cigarettes
Standard Deviation 103.00
|
185.8 cigarettes
Standard Deviation 97.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
Outcome data not reported
Adverse Events
Standard Cigarette Packs (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cigarette Packs With Inserts Only
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cigarette Packs With Pictorial Warnings Only
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cigarette Packs With Inserts and Pictorial Warnings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Cigarette Packs (Control)
n=108 participants at risk
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.
|
Cigarette Packs With Inserts Only
n=94 participants at risk
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.
|
Cigarette Packs With Pictorial Warnings Only
n=94 participants at risk
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.
|
Cigarette Packs With Inserts and Pictorial Warnings
n=91 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Heart Attack
|
0.00%
0/108 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
1.1%
1/94 • Number of events 1 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
0.00%
0/94 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
0.00%
0/91 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
|
Vascular disorders
Mini stroke
|
0.00%
0/108 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
0.00%
0/94 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
1.1%
1/94 • Number of events 1 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
0.00%
0/91 • Adverse events were assessed during the 14 day study participation period.
Adverse events were detected through the standardized study protocol of phoning participants when they stopped recording cigarettes and responding to evening surveys. Through this approach, we detected two adverse events that required hospitalization and may have been caused by long-term smoking.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place