Shrinking the Size of the Tobacco Power Wall

Tobacco Use Clinical Trial

Official title:

Shrinking the Size of the Tobacco Power Wall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632030
• Other study ID #: R01DA050972
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: August 29, 2022

Study information

• Verified date: October 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.

Description:

This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that we developed to evaluate how altering aspects of tobacco promotion at POS influences tobacco use risk during simulated shopping experiences. The study will use a between-subjects design, in which adolescents are randomly assigned to shop in the RSL under one of three conditions: (1) Large power wall/ multiple product units displayed; (2) Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single product units displayed. We will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: August 29, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

Inclusion Criteria:

• between the ages of 11 and 20

Exclusion Criteria:

• any medical or psychological condition that would make participation in the procedures of the study difficult (based on self-report).

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• Tobacco power wall size and tobacco products displayed
The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.

Locations

Country	Name	City	State
United States	RAND	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion at Risk for Cigarette Smoking	A two item self-report assessment: 1) If one of your best friends offered you an unflavored cigarette would you use it? 2) If one of your best friends offered you a menthol cigarette would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the two items are summed for a total scale score. Total scale scores are dichotomized: scores of 2 are coded as '0' (no risk) and any score greater than 2 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).	within 5 minutes of the intervention
Primary	Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS)	A three item, self-report assessment: 1) If one of your best friends offered you an unflavored vaping product would you use it? 2) If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it? 3) If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. 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 ENDS use (number of participants at risk over number of participants within condition).	within 5 minutes of the intervention
Primary	Proportion at Risk of Using Smokeless Tobacco	A three item self report assessment: : 1) If one of your best friends offered you unflavored smokeless tobacco would you use it? 2) If one of your best friends offered you smokeless tobacco flavored with flavored with menthol, mint, spearmint, or wintergreen would you use it? 3) If one of your best friends offered you smokeless tobacco flavored with fruit would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. 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).	within 5 minutes of the intervention
Primary	Proportion at Risk of Using Little Cigar/Cigarillos (LCC)	A three item, self report assessment: 1) If one of your best friends offered you an unflavored cigarillos/filtered cigar would you use it? 2) If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it? 3) If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. 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).	within 5 minutes of the intervention