Testing Legally Feasible Options Studies 2/3

NCT ID: NCT05604508

Last Updated: 2025-01-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2024-03-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Status Quo

This condition will allow for many posters with pricing information to be displayed.

Group Type ACTIVE_COMPARATOR

Many posters with prices

Intervention Type OTHER

No poster number or price restrictions

Reduced Poster

This condition will allow for a reduced number of posters with pricing information to be displayed.

Group Type EXPERIMENTAL

Fewer posters, no price restrictions

Intervention Type OTHER

Poster number restrictions, but no price restrictions

No price

This condition will allow for many posters with no pricing information to be displayed.

Group Type EXPERIMENTAL

Many posters, no prices

Intervention Type OTHER

No poster number restrictions, but price restrictions

Interventions

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Many posters with prices

No poster number or price restrictions

Intervention Type OTHER

Many posters, no prices

No poster number restrictions, but price restrictions

Intervention Type OTHER

Fewer posters, no price restrictions

Poster number restrictions, but no price restrictions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RAND

OTHER

Sponsor Role lead

Responsible Party

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William Shadel

Senior Behavioral Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RAND Corporation

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01CA236608

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA236608studies23

Identifier Type: -

Identifier Source: org_study_id

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