- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04632030
Shrinking the Size of the Tobacco Power Wall
October 5, 2023 updated by: William Shadel, RAND
Shrinking the Size of the Tobacco Power Wall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
275
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William G Shadel, PhD
- Phone Number: 4489 412-683-2300
- Email: shadel@rand.org
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- RAND
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- between the ages of 11 and 20
Exclusion Criteria:
- any medical or psychological condition that would make participation in the procedures of the study difficult (based on self-report).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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)
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The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.
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Experimental: 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)
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The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.
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Experimental: 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).
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The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion at Risk for Cigarette Smoking
Time Frame: within 5 minutes of the intervention
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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).
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within 5 minutes of the intervention
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Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS)
Time Frame: within 5 minutes of the intervention
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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).
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within 5 minutes of the intervention
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Proportion at Risk of Using Smokeless Tobacco
Time Frame: within 5 minutes of the intervention
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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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within 5 minutes of the intervention
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Proportion at Risk of Using Little Cigar/Cigarillos (LCC)
Time Frame: within 5 minutes of the intervention
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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).
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within 5 minutes of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2020
Primary Completion (Actual)
August 29, 2022
Study Completion (Actual)
August 29, 2022
Study Registration Dates
First Submitted
November 10, 2020
First Submitted That Met QC Criteria
November 16, 2020
First Posted (Actual)
November 17, 2020
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- R01DA050972 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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