Clinical trial NCT04259749: Testing Legally Feasible Options: Study 1
Official title: Experimentally Testing Legally Feasible Regulatory Options for Reducing the Impact of the Point-of-sale Retail Environment on Adolescent Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 267
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Secondary outcomes:
measure: Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
measure: Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored)
timeFrame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: RAND
state: Pennsylvania
Study officials:
affiliation: RAND
name: William G Shadel, PhD
role: PRINCIPAL_INVESTIGATOR
References: