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Completed

NCT Number: NCT05604508

Testing Legally Feasible Options Studies 2/3

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 regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos). Study 2 and study 3 (out of 3 studies), occurring concurrently, will examine whether changing the number and content of posters on the outside doors at POS reduced adolescents' tobacco use risk.

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Key information

Conditions

Tobacco Use Behavior

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAND Corporation

Pittsburgh, Pennsylvania, 15213, United States

About this study

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 2 and Study 3.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ages 18-20, in college

-

Exclusion criteria

any medical or psychiatric condition which would make compliance with the study protocol difficult (based on parent report).

Previous participation in a previous StoreLab study

Treatment and study plan

Many posters with prices

Other

No poster number or price restrictions

Many posters, no prices

Other

No poster number restrictions, but price restrictions

Fewer posters, no price restrictions

Other

Poster number restrictions, but no price restrictions

Primary outcomes

  1. Self-reported Cigarette Smoking Risk After Shopping in the StoreLab

    Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation

    Respondents answer the following items: "Do you think you will try a cigarette anytime soon?", "Do you think you will try a cigarette anytime in the next year?"; and "If one of your best friends offered you a cigarette, would you smoke it?". Responses are made on a 1 (Definitely not) to 10 (Definitely yes) scale and summed to produce a total smoking risk scale score (range from 3 - 30). 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 cigarette smoking (number of participants at risk over number of participants within condition).

  2. Self-reported Vaping/ENDS Risk of Use

    Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes after experimental manipulation

    Respondents answer the following items: "Do you think you will try a vaping product anytime soon?", "Do you think you will try a vaping product anytime in the next year?"; and "If one of your best friends offered you a vaping product, would you use it?". Responses are made on a 1 (Definitely not) to 10 (Definitely yes) scale and summed to produce a total vaping risk scale score (range from 3 - 30). 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 vaping (number of participants at risk over number of participants within condition).

  3. Self-reported Smokeless Tobacco Use Risk

    Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation

    Respondents answer the following items: "Do you think you will use smokeless tobacco anytime soon?", "Do you think you will try smokeless tobacco anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco, would you use it?". Responses are made on a 1 (Definitely not) to 4 (Definitely yes) scale and summed to produce a total smokeless tobacco risk scale score (range from 3 - 30). 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).

  4. Self-reported Cigarillo/Little Cigar *LCC) Use Risk

    Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation

    Respondents answer the following items: "Do you think you will try a cigarillo/little cigar anytime soon?", "Do you think you will try a cigarillo anytime in the next year?"; and "If one of your best friends offered you a cigarillo, would you smoke it?". Responses are made on a 1 (Definitely not) to 4 (Definitely yes) scale and summed to produce a total cigarillo risk scale score (range from 3 - 30). 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).

Sponsors and collaborators

Lead sponsor

RAND

Other

Registry information

Official study title

Testing Legally Feasible Options at Retail Point of Sale - Prices and Posters

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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