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The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.
This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that we developed to evaluate how altering aspects of tobacco promotion at POS influences tobacco use risk during simulated shopping experiences. The study will use a between-subjects design, in which adolescents are randomly assigned to shop in the RSL under one of three conditions: (1) Large power wall/ multiple product units displayed; (2) Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single product units displayed. We will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | The tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets) |
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| Small | Experimental | The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) |
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| Medium | Experimental | The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco power wall size and tobacco products displayed | Behavioral | The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion at Risk for Cigarette Smoking | A two item self-report assessment: 1) If one of your best friends offered you an unflavored cigarette would you use it? 2) If one of your best friends offered you a menthol cigarette would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the two items are summed for a total scale score. Total scale scores are dichotomized: scores of 2 are coded as '0' (no risk) and any score greater than 2 is coded as '1' (at risk). Outcome is proportion at risk of cigarette smoking (number of participants at risk over number of participants within condition). | within 5 minutes of the intervention |
| Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS) | A three item, self-report assessment: 1) If one of your best friends offered you an unflavored vaping product would you use it? 2) If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it? 3) If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of ENDS use (number of participants at risk over number of participants within condition). | within 5 minutes of the intervention |
| Proportion at Risk of Using Smokeless Tobacco | A three item self report assessment: : 1) If one of your best friends offered you unflavored smokeless tobacco would you use it? 2) If one of your best friends offered you smokeless tobacco flavored with flavored with menthol, mint, spearmint, or wintergreen would you use it? 3) If one of your best friends offered you smokeless tobacco flavored with fruit would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk).Outcome is proportion at risk of smokeless tobacco use (number of participants at risk over number of participants within condition). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAND | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| FG001 | Small | The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| FG002 | Medium | The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| 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 | Proportion at Risk for Cigarette Smoking | A two item self-report assessment: 1) If one of your best friends offered you an unflavored cigarette would you use it? 2) If one of your best friends offered you a menthol cigarette would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the two items are summed for a total scale score. Total scale scores are dichotomized: scores of 2 are coded as '0' (no risk) and any score greater than 2 is coded as '1' (at risk). Outcome is proportion at risk of cigarette smoking (number of participants at risk over number of participants within condition). | Sample size may differ from baseline because of missing data. | Posted | Number | 95% Confidence Interval | proportion of participants | within 5 minutes of the intervention |
|
One day
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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 | Control | The tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William G. Shadel | RAND | 412-683-2300 | 4489 | shadel@rand.org |
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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 17, 2023 | Aug 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| within 5 minutes of the intervention |
| Proportion at Risk of Using Little Cigar/Cigarillos (LCC) | A three item, self report assessment: 1) If one of your best friends offered you an unflavored cigarillos/filtered cigar would you use it? 2) If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it? 3) If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of LCC use (number of participants at risk over number of participants within condition). | within 5 minutes of the intervention |
| BG001 |
| Small |
The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| BG002 | Medium | The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| BG003 | Total | Total of all reporting groups |
| years |
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| 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 |
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| Region of Enrollment | Number | participants |
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| OG001 | Small | The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
| OG002 | Medium | The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. |
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| Primary | Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS) | A three item, self-report assessment: 1) If one of your best friends offered you an unflavored vaping product would you use it? 2) If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it? 3) If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of ENDS use (number of participants at risk over number of participants within condition). | Sample sizes may differ from baseline because of missing data. | Posted | Number | 95% Confidence Interval | proportion of participants | within 5 minutes of the intervention |
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| Primary | Proportion at Risk of Using Smokeless Tobacco | A three item self report assessment: : 1) If one of your best friends offered you unflavored smokeless tobacco would you use it? 2) If one of your best friends offered you smokeless tobacco flavored with flavored with menthol, mint, spearmint, or wintergreen would you use it? 3) If one of your best friends offered you smokeless tobacco flavored with fruit would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk).Outcome is proportion at risk of smokeless tobacco use (number of participants at risk over number of participants within condition). | Sample size may differ from baseline due to missing data. | Posted | Number | 95% Confidence Interval | proportion of participants | within 5 minutes of the intervention |
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| Primary | Proportion at Risk of Using Little Cigar/Cigarillos (LCC) | A three item, self report assessment: 1) If one of your best friends offered you an unflavored cigarillos/filtered cigar would you use it? 2) If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it? 3) If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of LCC use (number of participants at risk over number of participants within condition). | Sample sizes may differ from baseline due to missing data. | Posted | Number | 95% Confidence Interval | proportion of participants | within 5 minutes of the intervention |
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| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Small | The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. | 0 | 86 | 0 | 86 | 0 | 86 |
| EG002 | Medium | The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). Tobacco power wall size and tobacco products displayed: The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. | 0 | 93 | 0 | 93 | 0 | 93 |
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| Odds Ratio (OR) |
| 2.87 |
| 2-Sided |
| 95 |
| 1.26 |
| 6.50 |
Adjusted for age, education, and lifetime tobacco use |
| Other |
| Odds Ratio (OR) |
| 1.85 |
| 2-Sided |
| 95 |
| .73 |
| 4.67 |
Adjusted for age, education, and lifetime tobacco use |
| Other |
| Odds Ratio (OR) |
| 2.19 |
| 2-Sided |
| 95 |
| .94 |
| 5.13 |
Adjusted for age, education, and lifetime tobacco use |
| Other |