Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of South Carolina
- Enrollment
- 387
- Locations
- 2
- Primary Endpoint
- Strength of Feeling About Smoking
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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).
Intervention: Inserts with efficacy messages (Other)
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.
Intervention: Pictorial warnings on packs (Other)
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).
Intervention: Inserts with efficacy messages (Other)
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).
Intervention: Pictorial warnings on packs (Other)
Outcomes
Primary Outcomes
Strength of Feeling About Smoking
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.
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
Self-efficacy to Quit Smoking
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.
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
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.
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.
Extent of Motivation to Quit Smoking
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.
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.
Worry About Harms From Smoking
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.
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.
Foregoing a Cigarette
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.
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.
Talk About Smoking Cessation
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.
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.
Secondary Outcomes
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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).)
Investigators
James Francis Thrasher, PhD
Professor
University of South Carolina