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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA060049 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ads about response efficacy for quitting smoking | Experimental | Participants will view ads designed to increase response efficacy for quitting cigarettes. |
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| Ads about self-efficacy for quitting smoking | Experimental | Participants will view ads designed to increase self-efficacy to quit smoking. |
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| Ads about motivation to quit smoking | Experimental | Participants will view ads designed to increase motivation to quit smoking. |
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| Ads about reading | Other | Participants will view non-smoking related ads on the benefits of reading. |
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| Ads about passwords | Other | Participants will view non-smoking related ads on passwords. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention ads | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During exposure to the ads, assessed during one-time online 15-minute survey. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During exposure to the ads, assessed during one-time online 15-minute survey. |
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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
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Noel Brewer, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Marissa G Hall, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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The trial investigators will produce a de-identified dataset and codebook for sharing with external investigators, making use of the UNC Dataverse digital data repository (dataverse.unc.edu) hosted by the Odum Institute Data Archive.
The data will be available beginning 12 and continuing for 36 months following the primary publication.
To obtain a copy of the dataset and codebook, a research scientist will submit a request in writing, identifying themselves and their affiliated institution, indicating what they plan to do with the data, and including assurances that they will not share the data with others without the written permission of the PI. Requestors must already have institutional review board, independent ethics committee, or research ethics board approval, as applicable. Requestors must obtain a data use agreement through UNC's Office of Industry Contracting (OIC@unc.edu) to receive the dataset and codebook and agree to acknowledge NIH and the study investigators in any publications resulting from the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | During exposure to the ads, assessed during one-time online 15-minute survey. |
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From the time of signing informed consent, through completion of ~15 minute one time online survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | UNC | (919) 966-3282 | ntb@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2024 | Aug 19, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2024 | Jan 29, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Control ads | Behavioral | 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. |
|
| 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. | During exposure to the ads, assessed during one-time online 15-minute survey. |
| 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. | After exposure to the ads, assessed during one-time online 15-minute survey. |
| Response Efficacy | Belief that quitting smoking improves health, measured by 1 survey item. Range 1 to 5, with higher values indicating higher response efficacy. | After exposure to the ads, assessed during one-time online 15-minute survey. |
| Self-efficacy | Confidence that one can quit smoking, measured by 1 survey item. Range 1 to 5, with higher values indicating higher self-efficacy. | After exposure to the ads, assessed during one-time online 15-minute survey. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | During exposure to the ads, assessed during one-time online 15-minute survey. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | During exposure to the ads, assessed during one-time online 15-minute survey. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | After exposure to the ads, assessed during one-time online 15-minute survey. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | After exposure to the ads, assessed during one-time online 15-minute survey. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | After exposure to the ads, assessed during one-time online 15-minute survey. |
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| 0 |
| 247 |
| 0 |
| 247 |
| 0 |
| 247 |
| EG001 | 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. | 0 | 242 | 0 | 242 | 0 | 242 |
| EG002 | 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. | 0 | 251 | 0 | 251 | 0 | 251 |
| EG003 | 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. | 0 | 249 | 0 | 249 | 0 | 249 |
| EG004 | 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. | 0 | 247 | 0 | 247 | 0 | 247 |
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| Superiority |
| Regression, Linear | .35 | Superiority |
| Superiority |
| Regression, Linear | .62 | Superiority |
| Superiority |
| Regression, Linear | .33 | Superiority |
| Superiority |
| Regression, Linear | .38 | Superiority |
| Superiority |
| Regression, Linear | .4 | Superiority |