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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA241420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.
Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco smoking, which increases their risk of a variety of pulmonary, neurological, and oncological health conditions, among many others. This trial will randomly assign young adult waterpipe users or those susceptible to use to view waterpipe tobacco packages with text warning, pictorial warnings, or no warnings in a one-time online study. Participants will answer a series of questions regarding each package.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pictorial Warnings | Experimental | Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking |
|
| Text Warnings | Experimental | Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking |
|
| No Warnings (Control) | Experimental | Waterpipe tobacco package shown without a warning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pictorial Warnings | Behavioral | Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Intentions | The primary outcome is intention to smoke tobacco in a waterpipe within the next year, measured by averaging three items to create a composite score (adapted from research on cigarette smoking). The primary outcome will be measured after the exposure to waterpipe packages. Score ranges from 1-5 with higher score indicating greater intention to smoke hookah.
| Minute 2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Product Appeal | Three items will be used to measure how appealing each waterpipe tobacco package is to respondents, how likely they would be to try the product, and how much the packaging makes the respondent think that the product is harmful.
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Sutfin, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Warnings | Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking Text Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
| FG001 | Pictorial Warnings | Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking Pictorial Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
| FG002 | No Warnings (Control) | Waterpipe tobacco package shown without a warning No Warnings (Control): Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Warnings | Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking Text Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
| 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, Continuous | Mean |
| 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 | Behavioral Intentions | The primary outcome is intention to smoke tobacco in a waterpipe within the next year, measured by averaging three items to create a composite score (adapted from research on cigarette smoking). The primary outcome will be measured after the exposure to waterpipe packages. Score ranges from 1-5 with higher score indicating greater intention to smoke hookah.
| Posted | Mean | Standard Error | score on a scale | Minute 2 |
|
From the time of consent up to four weeks
Participants were randomized to one of three arms; two intervention arms and one control. Participants in the intervention arm saw six fictional hookah packages with either a text-only or pictorial health warnings; control participants saw single fictional hookah tobacco package with no health warnings.
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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 | Text Warnings | Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking Text Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin L. Sutfin, PhD | Wake Forest University School of Medicine | 336-713-5282 | esutfin@wakehealth.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 | Feb 21, 2024 | Apr 24, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2023 | Jun 1, 2023 | ICF_000.pdf |
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Participants randomized to the text-only condition will see six packages with different text warnings. Participants randomized to the pictorial condition will see six packages with different pictorial warnings. Participants in the control condition will see a single package without a warning.
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Participants will be blinded as to the comparators for their arm.
|
| Text Warnings | Behavioral | Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
|
| No Warnings (Control) | Behavioral | Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study. |
|
| Minute 2 |
| Perceived Message Effectiveness | This outcome will be measured using the 3-item Perceived Measured Effectiveness scale created by Noar and colleagues that includes items on attitudes, risk beliefs, and intentions. Mean scores will be calculated.
| Minute 2 |
| Attention | One item to measure self-reported attention to the warning. 1. How much does this warning grab your attention? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Minute 1 |
| Emotional Reactions | Three items to measure negative emotional reactions to the warning that the participant saw. Mean scores will be calculated.
| Minute 2 |
| Cognitive Elaboration | One item to measure the extent to which a participant reports the warning making them think about the risks of hookah smoking. 1. How much does this warning make you think about the health effects of smoking hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Minute 1 |
| Self-reported Learning | One item to measure the extent to which respondents learned something new from the warning. 1. To what extent did you learn something new from this warning that you did not already know? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Minute 1 |
| Social Interactions | One item to measure self-reported likelihood of discussing the warning shown with one's social contacts within the week following the survey. 1. How likely are you to talk about this warning with others in the next week? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Minute 1 |
| Knowledge | Six items to measure knowledge of the potential health harms described by the warnings.
| Minute 3 |
| Beliefs | Five items to measure the respondent's belief of their own risk of experiencing each of the warning health harms. One item measures risk to pregnant people, rather than the self, since this item will be administered to all participants.
| Minute 3 |
| Worry | Five/six items measuring a respondent's concern about their risk of warning health effects. Damage to fetuses will only be asked of respondents who report female sex at birth.
| Minute 3 |
| Quit Motivation | Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah. | Minute 1 |
| BG001 | Pictorial Warnings | Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking Pictorial Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
| BG002 | No Warnings (Control) | Waterpipe tobacco package shown without a warning No Warnings (Control): Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Pictorial Warnings | Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking Pictorial Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. |
| OG002 | No Warnings (Control) | Waterpipe tobacco package shown without a warning No Warnings (Control): Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study. |
|
|
| Other Pre-specified | Product Appeal | Three items will be used to measure how appealing each waterpipe tobacco package is to respondents, how likely they would be to try the product, and how much the packaging makes the respondent think that the product is harmful.
| Not Posted | Minute 2 | Participants |
| Other Pre-specified | Perceived Message Effectiveness | This outcome will be measured using the 3-item Perceived Measured Effectiveness scale created by Noar and colleagues that includes items on attitudes, risk beliefs, and intentions. Mean scores will be calculated.
| Not Posted | Minute 2 | Participants |
| Other Pre-specified | Attention | One item to measure self-reported attention to the warning. 1. How much does this warning grab your attention? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Not Posted | Minute 1 | Participants |
| Other Pre-specified | Emotional Reactions | Three items to measure negative emotional reactions to the warning that the participant saw. Mean scores will be calculated.
| Not Posted | Minute 2 | Participants |
| Other Pre-specified | Cognitive Elaboration | One item to measure the extent to which a participant reports the warning making them think about the risks of hookah smoking. 1. How much does this warning make you think about the health effects of smoking hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Not Posted | Minute 1 | Participants |
| Other Pre-specified | Self-reported Learning | One item to measure the extent to which respondents learned something new from the warning. 1. To what extent did you learn something new from this warning that you did not already know? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Not Posted | Minute 1 | Participants |
| Other Pre-specified | Social Interactions | One item to measure self-reported likelihood of discussing the warning shown with one's social contacts within the week following the survey. 1. How likely are you to talk about this warning with others in the next week? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal | Not Posted | Minute 1 | Participants |
| Other Pre-specified | Knowledge | Six items to measure knowledge of the potential health harms described by the warnings.
| Not Posted | Minute 3 | Participants |
| Other Pre-specified | Beliefs | Five items to measure the respondent's belief of their own risk of experiencing each of the warning health harms. One item measures risk to pregnant people, rather than the self, since this item will be administered to all participants.
| Not Posted | Minute 3 | Participants |
| Other Pre-specified | Worry | Five/six items measuring a respondent's concern about their risk of warning health effects. Damage to fetuses will only be asked of respondents who report female sex at birth.
| Not Posted | Minute 3 | Participants |
| Other Pre-specified | Quit Motivation | Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah. | Not Posted | Minute 1 | Participants |
| 0 |
| 396 |
| 0 |
| 396 |
| 0 |
| 396 |
| EG001 | Pictorial Warnings | Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking Pictorial Warnings: Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. | 0 | 402 | 0 | 402 | 0 | 402 |
| EG002 | No Warnings (Control) | Waterpipe tobacco package shown without a warning No Warnings (Control): Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study. | 0 | 417 | 0 | 417 | 0 | 417 |
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