NCT04632030

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

November 10, 2020

Results QC Date

August 21, 2023

Last Update Submit

October 5, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Control

ACTIVE COMPARATOR

The tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets)

Behavioral: Tobacco power wall size and tobacco products displayed

Small

EXPERIMENTAL

The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet)

Behavioral: Tobacco power wall size and tobacco products displayed

Medium

EXPERIMENTAL

The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets).

Behavioral: Tobacco power wall size and tobacco products displayed

Interventions

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

ControlMediumSmall

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between the ages of 11 and 20

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

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

November 10, 2020

First Posted

November 17, 2020

Study Start

October 30, 2020

Primary Completion

August 29, 2022

Study Completion

August 29, 2022

Last Updated

October 25, 2023

Results First Posted

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations