Skip to content

Testing Legally Feasible Options Studies 2/3

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05604508
Enrollment
445
Registered
2022-11-03
Start date
2022-10-12
Completion date
2024-03-07
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

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 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

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.

Interventions

OTHERMany posters with prices

No poster number or price restrictions

OTHERMany posters, no prices

No poster number restrictions, but price restrictions

OTHERFewer posters, no price restrictions

Poster number restrictions, but no price restrictions

Sponsors

RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 20 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported Cigarette Smoking Risk After Shopping in the StoreLabThere is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulationRespondents 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).
Self-reported Vaping/ENDS Risk of UseThere is one visit in this research: This variable is assessed at that visit, within 5 minutes after experimental manipulationRespondents 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).
Self-reported Smokeless Tobacco Use RiskThere is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulationRespondents 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).
Self-reported Cigarillo/Little Cigar *LCC) Use RiskThere is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulationRespondents 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Status Quo
This condition will allow for many posters with pricing information to be displayed. Many posters with prices: No poster number or price restrictions
150
Reduced Poster
This condition will allow for a reduced number of posters with pricing information to be displayed. Fewer posters, no price restrictions: Poster number restrictions, but no price restrictions
147
No Price
This condition will allow for many posters with no pricing information to be displayed. Many posters, no prices: No poster number restrictions, but price restrictions
148
Total445

Baseline characteristics

CharacteristicStatus QuoTotalNo PriceReduced Poster
Age, Continuous19.10 years
STANDARD_DEVIATION 0.77
19.14 years
STANDARD_DEVIATION 0.79
19.16 years
STANDARD_DEVIATION 0.78
19.16 years
STANDARD_DEVIATION 0.81
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants41 Participants11 Participants18 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
137 Participants400 Participants136 Participants127 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
51 Participants157 Participants51 Participants55 Participants
Race (NIH/OMB)
Black or African American
15 Participants40 Participants8 Participants17 Participants
Race (NIH/OMB)
More than one race
8 Participants25 Participants10 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants5 Participants3 Participants0 Participants
Race (NIH/OMB)
White
72 Participants213 Participants75 Participants66 Participants
Region of Enrollment
United States
150 Participants445 Participants148 Participants147 Participants
Sex/Gender, Customized
Gender identity
Female
102 Participants306 Participants106 Participants98 Participants
Sex/Gender, Customized
Gender identity
Male
31 Participants102 Participants33 Participants38 Participants
Sex/Gender, Customized
Gender identity
Other than male or female
16 Participants35 Participants9 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1500 / 1470 / 148
other
Total, other adverse events
0 / 1500 / 1470 / 148
serious
Total, serious adverse events
0 / 1500 / 1470 / 148

Outcome results

Primary

Self-reported Cigarette Smoking Risk After Shopping in the StoreLab

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).

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

Population: Some participants were missing data, which accounts for differences in the n.

ArmMeasureValue (NUMBER)
Status QuoSelf-reported Cigarette Smoking Risk After Shopping in the StoreLab.59 proportion of participants
Reduced PosterSelf-reported Cigarette Smoking Risk After Shopping in the StoreLab.52 proportion of participants
No PriceSelf-reported Cigarette Smoking Risk After Shopping in the StoreLab.39 proportion of participants
95% CI: [0.347, 1.553]
95% CI: [0.234, 0.947]
Primary

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

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).

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

Population: Some participants opted to not complete some items, hence the different n.

ArmMeasureValue (NUMBER)
Status QuoSelf-reported Cigarillo/Little Cigar *LCC) Use Risk0.36 proportion of participants
Reduced PosterSelf-reported Cigarillo/Little Cigar *LCC) Use Risk0.41 proportion of participants
No PriceSelf-reported Cigarillo/Little Cigar *LCC) Use Risk0.44 proportion of participants
95% CI: [0.72, 2.832]
95% CI: [0.681, 2.96]
Primary

Self-reported Smokeless Tobacco Use Risk

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).

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

Population: Some participants opted to not respond to some items, hence the different n.

ArmMeasureValue (NUMBER)
Status QuoSelf-reported Smokeless Tobacco Use Risk0.41 proportion of participants
Reduced PosterSelf-reported Smokeless Tobacco Use Risk0.30 proportion of participants
No PriceSelf-reported Smokeless Tobacco Use Risk0.23 proportion of participants
95% CI: [0.295, 1.301]
95% CI: [0.237, 1.006]
Primary

Self-reported Vaping/ENDS Risk of Use

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).

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

Population: Some participants opted to not answer some items, hence the differing n.

ArmMeasureValue (NUMBER)
Status QuoSelf-reported Vaping/ENDS Risk of Use0.55 proportion of participants
Reduced PosterSelf-reported Vaping/ENDS Risk of Use0.68 proportion of participants
No PriceSelf-reported Vaping/ENDS Risk of Use0.52 proportion of participants
95% CI: [0.727, 3.107]
95% CI: [0.398, 1.938]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026