Smoking Behaviors
Conditions
Brief summary
The main purpose of this trial is to identify effective quit smoking ads for people who smoke menthol cigarettes. Investigators will conduct an online randomized trial with a nationally representative sample of \ 1,400 US adults (ages 21+) who smoke menthol cigarettes.
Detailed description
This trial will evaluate the effectiveness of efficacy-based quit smoking ads in a 5 (theme) x 6 (ad) mixed factorial randomized design. Recruitment: A survey company will recruit \ 1,400 participants. Participants will complete a screener to confirm that they are US adults (ages 21+), currently smoke menthol cigarettes, and are able to read and speak English. A portion of the sample will be nationally representative, and a portion will be a convenience sample. Informed Consent: The consent form will appear on the first page of the survey. Participants will provide their consent to be in the trial by clicking on a button that forwards to the next page of the survey. Randomization: After consent, the survey software will randomize participants to 1 of 5 themes between-subjects. The design will include 3 intervention ad themes about quitting smoking (self-efficacy ads, response efficacy ads, or motivation ads) and 2 control ad themes about neutral non-smoking related topics (reading or password safety). Each participant will view 6 ads on their assigned theme, presented in a random order. Assessment: Participants will complete a \ 15 minute online survey one time.
Interventions
BEHAVIORALIntervention ads
The ads will be on topics to encourage quitting smoking, formatted as multi-color text with graphic elements. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message.
BEHAVIORALControl ads
The ads will be on topics unrelated to quitting smoking, formatted as black text on a white field. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message.
Sponsors
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
This national trial is not open to enrollment from the general public. Participation is restricted to individuals who meet the following inclusion and
Exclusion criteria
Inclusion Criteria * Currently smoke menthol cigarettes * Be a member of the AmeriSpeak online survey panel or their convenience sample * Live in the US * Be age 21 years or older * Read and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Message Effectiveness for Motivation | During exposure to the ads, assessed during one-time online 15-minute survey. | Perceived effectiveness of the ads at encouraging quitting smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Message Effectiveness for Response Efficacy | During exposure to the ads, assessed during one-time online 15-minute survey. | Perceived effectiveness of the ads at communicating the benefits of quitting smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness. |
| Perceived Message Effectiveness for Self-efficacy | During exposure to the ads, assessed during one-time online 15-minute survey. | Perceived effectiveness of the ads at creating confidence that one can quit smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness. |
| Intentions to Quit Smoking | After exposure to the ads, assessed during one-time online 15-minute survey. | Motivation to quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher intentions to quit smoking. |
| Response Efficacy | After exposure to the ads, assessed during one-time online 15-minute survey. | Belief that quitting smoking improves health, measured by 1 survey item. Range 1 to 5, with higher values indicating higher response efficacy. |
| Self-efficacy | After exposure to the ads, assessed during one-time online 15-minute survey. | Confidence that one can quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher self-efficacy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ads About Response Efficacy for Quitting Smoking Participants will view ads designed to increase response efficacy for quitting cigarettes.
Intervention ads: The ads will be on topics to encourage quitting smoking, formatted as multi-color text with graphic elements. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message. | 247 |
| Ads About Self-efficacy for Quitting Smoking Participants will view ads designed to increase self-efficacy to quit smoking.
Intervention ads: The ads will be on topics to encourage quitting smoking, formatted as multi-color text with graphic elements. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message. | 242 |
| Ads About Motivation to Quit Smoking Participants will view ads designed to increase motivation to quit smoking.
Intervention ads: The ads will be on topics to encourage quitting smoking, formatted as multi-color text with graphic elements. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message. | 251 |
| Ads About Reading Participants will view non-smoking related ads on the benefits of reading.
Control ads: The ads will be on topics unrelated to quitting smoking, formatted as black text on a white field. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message. | 249 |
| Ads About Passwords Participants will view non-smoking related ads on passwords.
Control ads: The ads will be on topics unrelated to quitting smoking, formatted as black text on a white field. Trial investigators developed the ads and optimized them to be readable when delivered in an SMS text message. | 247 |
| Total | 1,236 |
Baseline characteristics
| Characteristic | Ads About Self-efficacy for Quitting Smoking | Ads About Motivation to Quit Smoking | Ads About Reading | Ads About Response Efficacy for Quitting Smoking | Ads About Passwords | Total |
|---|---|---|---|---|---|---|
| Age, Customized 21-29 years | 22 Participants | 23 Participants | 30 Participants | 30 Participants | 28 Participants | 133 Participants |
| Age, Customized 30-39 years | 71 Participants | 73 Participants | 66 Participants | 73 Participants | 73 Participants | 356 Participants |
| Age, Customized 40-49 years | 53 Participants | 55 Participants | 65 Participants | 48 Participants | 54 Participants | 275 Participants |
| Age, Customized 50-59 years | 38 Participants | 40 Participants | 40 Participants | 38 Participants | 39 Participants | 195 Participants |
| Age, Customized 60+ years | 58 Participants | 60 Participants | 48 Participants | 58 Participants | 53 Participants | 277 Participants |
| Race/Ethnicity, Customized Another race / ethnicity | 17 Participants | 12 Participants | 11 Participants | 14 Participants | 16 Participants | 70 Participants |
| Race/Ethnicity, Customized Hispanic | 27 Participants | 35 Participants | 41 Participants | 26 Participants | 37 Participants | 166 Participants |
| Race/Ethnicity, Customized Multiracial | 8 Participants | 7 Participants | 7 Participants | 15 Participants | 10 Participants | 47 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 66 Participants | 69 Participants | 54 Participants | 59 Participants | 63 Participants | 311 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 124 Participants | 128 Participants | 136 Participants | 133 Participants | 121 Participants | 642 Participants |
| Sex: Female, Male Female | 162 Participants | 156 Participants | 160 Participants | 149 Participants | 150 Participants | 777 Participants |
| Sex: Female, Male Male | 80 Participants | 95 Participants | 89 Participants | 98 Participants | 97 Participants | 459 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 247 | 0 / 242 | 0 / 251 | 0 / 249 | 0 / 247 |
| other Total, other adverse events | 0 / 247 | 0 / 242 | 0 / 251 | 0 / 249 | 0 / 247 |
| serious Total, serious adverse events | 0 / 247 | 0 / 242 | 0 / 251 | 0 / 249 | 0 / 247 |
Outcome results
Primary
Perceived Message Effectiveness for Motivation
Perceived effectiveness of the ads at encouraging quitting smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness.
Time frame: During exposure to the ads, assessed during one-time online 15-minute survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ads About Response Efficacy for Quitting Smoking | Perceived Message Effectiveness for Motivation | 3.18 score on a scale | Standard Deviation 1.05 |
| Ads About Self-efficacy for Quitting Smoking | Perceived Message Effectiveness for Motivation | 2.40 score on a scale | Standard Deviation 0.99 |
| Ads About Motivation to Quit Smoking | Perceived Message Effectiveness for Motivation | 2.49 score on a scale | Standard Deviation 1.02 |
| Ads About Reading | Perceived Message Effectiveness for Motivation | 1.49 score on a scale | Standard Deviation 0.87 |
| Ads About Passwords | Perceived Message Effectiveness for Motivation | 1.41 score on a scale | Standard Deviation 0.88 |
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: 0.56Regression, Linear
Secondary
Intentions to Quit Smoking
Motivation to quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher intentions to quit smoking.
Time frame: After exposure to the ads, assessed during one-time online 15-minute survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ads About Response Efficacy for Quitting Smoking | Intentions to Quit Smoking | 3.14 score on a scale | Standard Deviation 1.21 |
| Ads About Self-efficacy for Quitting Smoking | Intentions to Quit Smoking | 2.90 score on a scale | Standard Deviation 1.31 |
| Ads About Motivation to Quit Smoking | Intentions to Quit Smoking | 2.99 score on a scale | Standard Deviation 1.29 |
| Ads About Reading | Intentions to Quit Smoking | 2.94 score on a scale | Standard Deviation 1.34 |
| Ads About Passwords | Intentions to Quit Smoking | 2.82 score on a scale | Standard Deviation 1.35 |
p-value: 0.03Regression, Linear
p-value: 0.17Regression, Linear
p-value: 0.33Regression, Linear
Secondary
Perceived Message Effectiveness for Response Efficacy
Perceived effectiveness of the ads at communicating the benefits of quitting smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness.
Time frame: During exposure to the ads, assessed during one-time online 15-minute survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ads About Response Efficacy for Quitting Smoking | Perceived Message Effectiveness for Response Efficacy | 3.32 score on a scale | Standard Deviation 1.01 |
| Ads About Self-efficacy for Quitting Smoking | Perceived Message Effectiveness for Response Efficacy | 2.23 score on a scale | Standard Deviation 1.02 |
| Ads About Motivation to Quit Smoking | Perceived Message Effectiveness for Response Efficacy | 2.33 score on a scale | Standard Deviation 1.04 |
| Ads About Reading | Perceived Message Effectiveness for Response Efficacy | 1.48 score on a scale | Standard Deviation 0.86 |
| Ads About Passwords | Perceived Message Effectiveness for Response Efficacy | 1.44 score on a scale | Standard Deviation 0.91 |
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: 0.35Regression, Linear
Secondary
Perceived Message Effectiveness for Self-efficacy
Perceived effectiveness of the ads at creating confidence that one can quit smoking, measured by 1 survey item for each ad (6 items total). Range 1 to 5, with higher values indicating higher perceived message effectiveness.
Time frame: During exposure to the ads, assessed during one-time online 15-minute survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ads About Response Efficacy for Quitting Smoking | Perceived Message Effectiveness for Self-efficacy | 2.94 score on a scale | Standard Deviation 1.14 |
| Ads About Self-efficacy for Quitting Smoking | Perceived Message Effectiveness for Self-efficacy | 2.49 score on a scale | Standard Deviation 0.96 |
| Ads About Motivation to Quit Smoking | Perceived Message Effectiveness for Self-efficacy | 2.45 score on a scale | Standard Deviation 1.04 |
| Ads About Reading | Perceived Message Effectiveness for Self-efficacy | 1.48 score on a scale | Standard Deviation 0.85 |
| Ads About Passwords | Perceived Message Effectiveness for Self-efficacy | 1.43 score on a scale | Standard Deviation 0.89 |
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: 0.62Regression, Linear
Secondary
Response Efficacy
Belief that quitting smoking improves health, measured by 1 survey item. Range 1 to 5, with higher values indicating higher response efficacy.
Time frame: After exposure to the ads, assessed during one-time online 15-minute survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ads About Response Efficacy for Quitting Smoking | Response Efficacy | 3.50 score on a scale | Standard Deviation 0.79 |
| Ads About Self-efficacy for Quitting Smoking | Response Efficacy | 3.93 score on a scale | Standard Deviation 1.18 |
| Ads About Motivation to Quit Smoking | Response Efficacy | 3.96 score on a scale | Standard Deviation 1.12 |
| Ads About Reading | Response Efficacy | 4.00 score on a scale | Standard Deviation 1.23 |
| Ads About Passwords | Response Efficacy | 3.91 score on a scale | Standard Deviation 1.25 |
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: 0.38Regression, Linear
Secondary
Self-efficacy
Confidence that one can quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher self-efficacy.
Time frame: After exposure to the ads, assessed during one-time online 15-minute survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ads About Response Efficacy for Quitting Smoking | Self-efficacy | 2.93 score on a scale | Standard Deviation 1.27 |
| Ads About Self-efficacy for Quitting Smoking | Self-efficacy | 2.87 score on a scale | Standard Deviation 1.27 |
| Ads About Motivation to Quit Smoking | Self-efficacy | 2.88 score on a scale | Standard Deviation 1.19 |
| Ads About Reading | Self-efficacy | 2.87 score on a scale | Standard Deviation 1.27 |
| Ads About Passwords | Self-efficacy | 2.78 score on a scale | Standard Deviation 1.29 |
p-value: 0.6Regression, Linear
p-value: 0.65Regression, Linear
p-value: 0.4Regression, Linear