Testing Legally Feasible Options: Study 1

NCT04259749 | Completed Results

• 1 other identifier: R01CA236608
• Study Type: interventional
• Target: 267
• 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 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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)

  Self-report items: "Do you think you will try an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime soon?", "Do you think you will smoke an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarette (unflavored = cigarettes without menthol or mint), would you smoke it?". Responses to each item are made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed for a total scale score. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

• Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)

  Self-report items: "Do you think you will try a cigarette flavored with menthol or mint anytime soon?", "Do you think you will smoke a cigarette flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarette flavored with menthol or mint, would you smoke it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Secondary Outcomes (9)

• Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

• Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

• Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

• Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

• Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)

  There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Study Arms (3)

Status Quo

ACTIVE COMPARATOR

The StoreLab power wall will display all tobacco products.

Other: All flavored and mentholated products available

Flavors Banned

EXPERIMENTAL

The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed.

Other: Flavor Ban

Flavors and Menthol Banned

EXPERIMENTAL

The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed.

Other: Flavor Ban; Other: Menthol Ban

Interventions

Flavor Ban OTHER

Only flavored tobacco products are banned

Flavors Banned; Flavors and Menthol Banned

Menthol Ban OTHER

Mentholated products are banned

Flavors and Menthol Banned

All flavored and mentholated products available OTHER

No bans: All tobacco products are available

Status Quo

Eligibility Criteria

• Age: 11 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ages 11-20, parental consent/adolescent assent for minors

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 (by either adolescent or parent) in a previous StoreLab study

Sponsors & Collaborators

• RAND: lead

Study Sites (1)

RAND

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: William G. Shadel
• Organization: RAND

shadel@rand.org

412-683-2300

Study Officials

• William G Shadel, PhD

  RAND

  PRINCIPAL INVESTIGATOR

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: February 2, 2020
• First Posted: February 6, 2020
• Study Start: January 16, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 30, 2023
• Results First Posted: October 30, 2023

Record last verified: 2023-10

Locations

US (1)