Testing Legally Feasible Options: Study 1

October 4, 2023 updated by: William Shadel, RAND

Experimentally Testing Legally Feasible Regulatory Options for Reducing the Impact of the Point-of-sale Retail Environment on Adolescent Tobacco Use

The overall aim of this research is to experimentally evaluate different, legally-viable approaches to reducing the impact of the point-of-sale (POS) retail environment on adolescent tobacco use risk. This study will be investigating the regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos). Study 1 (study 1 out of 3 proposed) will examine whether eliminating the sale of flavored tobacco products at POS reduced adolescents' tobacco use risk.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tobacco advertising at retail point-of-sale (POS) includes promotional allowances that permit tobacco products to be advertised and sold at reduced cost to consumers (e.g., two-for-one specials); high visibility sale and therefore placement of hundreds of tobacco products on power walls; and the display of a large, diverse collection of poster advertisements on the exterior of the stores. Adolescents are at significant risk for having repeated exposures to this tobacco rich POS environment and such exposures contribute to increases in adolescent tobacco use. Although curbing the effect of the tobacco rich POS environment on adolescent tobacco use is a critical public health goal, some POS advertising regulations are unlikely to be viable in the United States because they impinge upon the tobacco industry's commercial free speech rights. For example, eliminating the tobacco power wall is probably not a viable option in the US as it has been successfully challenged in court by the tobacco industry. POS regulations that do not violate the industry's commercial free speech rights stand a better chance of being upheld by the courts. For example, eliminating tobacco product price promotions, reducing the availability of tobacco products by restricting the sale of flavored products, and restricting how much door/window space tobacco product posters can occupy at POS, all have been implemented as feasible and legally defensible regulatory options at POS. The evidence base supporting the efficacy of these initiatives is, however, almost non-existent - leaving them open to legal scrutiny. The overall aim of this research is to experimentally evaluate different, legally-viable approaches to reducing the impact of the POS retail environment on adolescent tobacco use risk. This research will be investigating the regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos): the extent to which eliminating tobacco product price promotions (Study 2), restricting how much door/window space tobacco posters can occupy at POS (Study 3), and eliminating the sale of flavored and/or mentholated tobacco products (Study 1) reduce adolescent tobacco-use risk. Each study will evaluate for possible gender and race (African-American vs Caucasian) differences. The studies will take place in the RAND StoreLab, a life-sized replica of a convenience store that was developed to experimentally evaluate how altering aspects of tobacco promotion at POS influences tobacco use. The present record is for Study 1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: William G Shadel, PhD
  • Phone Number: 4489 412-683-2300
  • Email: shadel@rand.org

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • RAND

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ages 11-20, parental consent/adolescent assent for minors

Exclusion Criteria:

  • any medical or psychiatric condition which would make compliance with the study protocol difficult (based on parent report).
  • Previous participation (by either adolescent or parent) in a previous StoreLab study

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Status Quo
The StoreLab power wall will display all tobacco products.
Other: All flavored and mentholated products available
No bans: All tobacco products are available
Experimental: Flavors Banned
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed.
Other: Flavor Ban
Only flavored tobacco products are banned
Experimental: Flavors and Menthol Banned
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed.
Other: Flavor Ban
Only flavored tobacco products are banned
Other: Menthol Ban
Mentholated products are banned

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime soon?", "Do you think you will smoke an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarette (unflavored = cigarettes without menthol or mint), would you smoke it?". Responses to each item are made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed for a total scale score. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try a cigarette flavored with menthol or mint anytime soon?", "Do you think you will smoke a cigarette flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarette flavored with menthol or mint, would you smoke it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try an unflavored vaping product soon?", "Do you think you will use an unflavored vaping product anytime in the next year?"; and "If one of your best friends offered you an unflavored vaping product would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is number of participants susceptible to using ENDS after shopping in the StoreLab (non-flavored). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor soon?", "Do you think you will use a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor anytime in the next year?"; and "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 were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scaled score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try a vaping product flavored with menthol or mint soon?", "Do you think you will use a vaping product flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try an unflavored cigarillos/filtered cigar soon?", "Do you think you will use an unflavored cigarillos/filtered cigar anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarillos/filtered cigar, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor soon?", "Do you think you will use a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor anytime in the next year?"; and "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 were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with menthol or mint soon?", "Do you think you will use a cigarillos/filtered cigar flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number of susceptible over number in condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try unflavored smokeless tobacco soon?", "Do you think you will use unflavored smokeless tobacco anytime in the next year?"; and "If one of your best friends offered you unflavored smokeless tobacco, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try smokeless tobacco flavored with fruit soon?", "Do you think you will use smokeless tobacco flavored with fruit anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with fruit, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored)
Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Self-report items: "Do you think you will try smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen soon?", "Do you think you will use smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAND

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William G Shadel, PhD, RAND

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01CA236608 (U.S. NIH Grant/Contract)

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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