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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/MEDICINE/GEN INT MD | Other Identifier | UW Madison | |
| Version date 2/6/2023 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Centiment LLC | INDUSTRY |
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The goal of this study is to examine different messages to motivate smokers who self-identify as an African American current smoker, between the ages of 50-80 years old to quit smoking. Participants will be asked to complete a survey and look at two messages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Big tobacco" video message and flyer | Active Comparator | Participants will view a "Big tobacco" video message and flyer. |
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| "It's never too late" video message and flyer | Active Comparator | Participants will view a "It's never too late" video message and flyer. |
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| Placebo Message | Placebo Comparator | Participants will view a water advertisement and flyer. |
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| Fear message video and flyer | Active Comparator | Participants will view a fear message video and flyer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rate Emotional Response | Behavioral | Participants will view their assigned video package, and will be asked to rate their emotional response to the message |
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| Measure | Description | Time Frame |
|---|---|---|
| Motivation to Quit Smoking | Change in participants' motivation to quit pre- and post-viewing of the experimental flyer and video, using a 1 item scaled measurement of motivation to quit (1-7 scale, 7 indicating higher motivation) measured in a single online survey (~15 minutes). | data collected before and after intervention (baseline and approximately 15 minutes later) |
| Emotional Response - Sad | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Angry | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Afraid | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). Emotionality will be presented together summarizing the mean presentation of these emotions by the different groups. | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Guilty | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Disgusted |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrienne Johnson, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | "Big Tobacco" Video Message and Flyer | Participants will view a "Big tobacco" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| FG001 | "It's Never Too Late" Video Message and Flyer | Participants will view a "It's never too late" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| FG002 | Placebo Message | Participants will view a water advertisement and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| FG003 | Fear Message Video and Flyer | Participants will view a fear message video and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | "Big Tobacco" Video Message and Flyer | Participants will view a "Big tobacco" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| 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, Categorical | 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 | Motivation to Quit Smoking | Change in participants' motivation to quit pre- and post-viewing of the experimental flyer and video, using a 1 item scaled measurement of motivation to quit (1-7 scale, 7 indicating higher motivation) measured in a single online survey (~15 minutes). | Posted | Mean | Standard Deviation | score on a scale | data collected before and after intervention (baseline and approximately 15 minutes later) |
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Subject participation lasted 15 minutes.
No adverse events were reported.
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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 | "Big Tobacco" Video Message and Flyer | Participants will view a "Big tobacco" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention | 608-262-7568 | mark.zehner@ctri.wisc.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 | Sep 6, 2024 | Sep 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| Rate Impact of Message | Behavioral | Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
|
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Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). |
| data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Worried | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Ashamed | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Confused | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Amused | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Hopeful | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Motivated | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Understood | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Happy | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| Emotional Response - Surprised | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | data collected at one time point, post-intervention, up to approximately 15 minutes |
| BG001 | "It's Never Too Late" Video Message and Flyer | Participants will view a "It's never too late" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| BG002 | Placebo Message | Participants will view a water advertisement and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| BG003 | Fear Message Video and Flyer | Participants will view a fear message video and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Endorsing Black/African American race was an inclusion criteria for the study. Additionally, the following question was asked: "Which racial group do you most strongly identify with **(choose all that apply)**?: White/Caucasian; Native Hawaiian/Pacific Islander; Asian; Native American/Alaska Native; other; refused. | Number | Endorsements |
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| Region of Enrollment | Number | participants |
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| OG001 |
| "It's Never Too Late" Video Message and Flyer |
Participants will view a "It's never too late" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| OG002 | Placebo Message | Participants will view a water advertisement and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
| OG003 | Fear Message Video and Flyer | Participants will view a fear message video and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. |
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| Primary | Emotional Response - Sad | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Angry | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Afraid | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). Emotionality will be presented together summarizing the mean presentation of these emotions by the different groups. | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Guilty | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Disgusted | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Worried | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Ashamed | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Confused | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Amused | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Hopeful | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Motivated | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Understood | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Happy | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| Primary | Emotional Response - Surprised | Measure participants' emotional response to the messages using a 1-9 scaled measurement of 14 different emotions (9 indicating more emotional response). | Posted | Mean | Standard Deviation | score on a scale | data collected at one time point, post-intervention, up to approximately 15 minutes |
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| 0 |
| 219 |
| 0 |
| 219 |
| 0 |
| 219 |
| EG001 | "It's Never Too Late" Video Message and Flyer | Participants will view a "It's never too late" video message and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. | 0 | 207 | 0 | 207 | 0 | 207 |
| EG002 | Placebo Message | Participants will view a water advertisement and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. | 0 | 210 | 0 | 210 | 0 | 210 |
| EG003 | Fear Message Video and Flyer | Participants will view a fear message video and flyer. Rate Emotional Response: Participants will view their assigned video package, and will be asked to rate their emotional response to the message Rate Impact of Message: Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking. | 0 | 203 | 0 | 203 | 0 | 203 |
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