Testing Legally Feasible Options Studies 2/3

NCT05604508 | Completed Results

• 2 other identifiers: R01CA236608studies23R01CA236608
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (4)

• 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).

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

• 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).

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

• 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).

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

• 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).

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

Study Arms (3)

Status Quo

ACTIVE COMPARATOR

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

Other: Many posters with prices

Reduced Poster

EXPERIMENTAL

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

Other: Fewer posters, no price restrictions

No price

EXPERIMENTAL

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

Other: Many posters, no prices

Interventions

Many posters with prices OTHER

No poster number or price restrictions

Status Quo

Many posters, no prices OTHER

No poster number restrictions, but price restrictions

No price

Fewer posters, no price restrictions OTHER

Poster number restrictions, but no price restrictions

Reduced Poster

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-20, in college

You may not qualify if:

• 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

Sponsors & Collaborators

• RAND: lead

Study Sites (1)

RAND Corporation

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Commerce

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Results Point of Contact

• Title: William Shadel
• Organization: RAND

shadel@rand.org

4126832300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Behavioral Scientist

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: October 12, 2022
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: January 13, 2025
• Results First Posted: January 3, 2025

Record last verified: 2025-01

Locations

US (1)