Health Behavior
Conditions
Brief summary
The main purpose of this trial is to evaluate the impact of a menthol cigarette ban accompanied by a quit smoking campaign on tobacco purchasing behavior. Investigators will conduct a randomized clinical trial with \ 1,185 US adults (ages 21+ years) who currently smoke menthol cigarettes.
Detailed description
This trial aims to determine whether a quit smoking campaign amplifies the impact of a simulated menthol cigarette ban. The trial will enroll \ 1,185 adults ages 21 years and older who currently smoke menthol cigarettes. Participants will attend 2 in-person study visits at our experimental store, spaced approximately 1 week apart. The store will be stocked with a variety of tobacco products, food, non-alcoholic beverages, and household goods. At the first visit, participants will provide written informed consent and will be randomized to 1 of 3 trial arms, described further below. At both study visits, participants will shop for items in the store and complete computer surveys. Researchers will record in-store purchases and other self-reported measures will be assessed via the computer surveys. In between the in-person study visits, participants will receive ads via text message based on their trial arm.
Interventions
BEHAVIORALMenthol ban + campaign
Menthol cigarettes and flavored little cigars and cigarillos will not be available for purchase in the store. Participants will receive quit smoking campaign ads via text message. These ads will also be displayed inside the store during the shopping tasks.
BEHAVIORALMenthol ban
Menthol cigarettes and flavored little cigars and cigarillos will not be available for purchase in the store. Participants will receive control ads about a neutral topic (i.e., password security) via text message. These ads will also be displayed inside the store during the shopping tasks.
BEHAVIORALControl
Menthol cigarettes and flavored little cigars and cigarillos will be available for purchase in the store. Participants will receive control ads about a neutral topic (i.e., password security) via text message. These ads will also be displayed inside the store during the shopping tasks.
Sponsors
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are ages 21 years and older * Smoke cigarettes currently (i.e. currently smoke some days or every day and have smoked at least 100 cigarettes in their lifetime) * Smoke menthol cigarettes * Purchased menthol cigarettes in a store in the past month * Read and speak English * Can complete a survey on a computer without help * Can receive images by text message * Can attend 2 in-person appointments involving shopping tasks and computer surveys
Exclusion criteria
* Are pregnant * Are breastfeeding * Enrolled currently in another research study about quitting smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Purchasing any combustible tobacco products | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using purchase data for combustible tobacco products, defined as any cigarettes or little cigars and cigarillos. Response options are "No" (coded as 0) and "Yes" (coded as 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expenditures on combustible tobacco products | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using purchase data for combustible tobacco products, defined as any cigarettes or little cigars and cigarillos. This measure is in US dollars, ranging from $0 to $70. |
| Purchasing any non-combustible tobacco products (substitution effects) | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using purchase data on whether participants bought any non-combustible tobacco products, defined as any e-cigarettes, smokeless tobacco, or nicotine pouches. Response options are "No" (coded as 0) and "Yes" (coded as 1). |
| Attempted to quit smoking | Assessed 1 time, approximately 1 week after enrollment. | Measured using 1 survey item: "In the last week, did you stop smoking cigarettes for 1 day or longer because you were trying to quit smoking?" Response options are "No" coded as 0) and "Yes" (coded as 1). |
| Forgoing cigarette use | Assessed 1 time, approximately 1 week after enrollment. | Measured using 2 survey items (e.g., " In the last week, how often have you stopped yourself from having a cigarette because you wanted to smoke less?"). The 5-point response scale ranges from "Never" coded as 0, to "10 or more times", coded as 10. Researchers will average responses to the 2 survey items to create a scale score. Higher scores indicate greater frequency of forgoing cigarettes. |
| Intentions to quit smoking | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 3 survey items (e.g., "How interested are you in quitting smoking cigarettes in the next 4 weeks?"). The 4-point response scale ranges from low intentions (coded as 1) to high intentions (coded as 4). Researchers will average responses to the 3 survey items to create a scale score. Higher scores indicate greater intentions to quit smoking. |
| Injunctive norms for quitting smoking | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 3 survey items (e.g., "People who are important to me think I should quit smoking."). The 5-point response scale ranges from "Strongly disagree" (coded as 1) to "Strongly agree" (coded as 5). Researchers will average responses to the 3 survey items to create a scale score. Higher scores indicate greater injunctive norms for quitting smoking. |
| Targeted benefits of quitting smoking | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 6 survey items (e.g., "If you were to stop smoking, how likely would you be to get more quality time with loved ones?"). The 5-point response scale ranges from "Not at all likely" (coded as 1) to "Extremely likely" (coded as 5). Researchers will average responses to the 7 survey items to create a scale score. Higher scores indicate greater targeted benefits of quitting smoking. |
| Reactance towards cigarette options | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 3 survey items (e.g., "I was annoyed by the cigarette options in the Mini Mart."). The 5-point response scale ranges from "Strongly disagree" (coded as 1) to "Strongly agree" (coded as 5). Researchers will average responses to the 3 survey items to create a scale score. Higher scores indicate greater reactance toward cigarette options. |
| Reactance towards ads | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 3 survey items (e.g., "The ads annoyed me."). The 5-point response scale ranging from "Strongly disagree" (coded as 1) to "Strongly agree" (coded as 5). Researchers will average responses to the 3 survey items to create a scale score. Higher scores indicate greater reactance toward ads. |
| Stigma from cigarette options | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 1 survey item (i.e., "How much did the cigarette options in the Mini Mart make you feel judged by other people for smoking?"). The 5-point response scale ranges from "Not at all" (coded as 1) to "A great deal" (coded as 5) to create a scale score. Higher scores indicate greater stigma from cigarette options. |
| Stigma from ads | Assessed 2 times approximately 1-week apart, starting on the day of enrollment. | Measured using 1 survey item (i.e., "How much did the ads make you feel judged by other people for smoking?"). The 5-point response scale ranges from "Not at all" (coded as 1) to "A great deal" (coded as 5). Higher scores indicate greater stigma from ads. |
Countries
United States
Contacts
STUDY_DIRECTORMarissa G. Hall, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed