NCT05393869

Brief Summary

This trial refines and evaluates anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine effective communication of polytobacco use risk to at-risk LGBT young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,849

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

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

April 14, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 26, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

May 18, 2022

Results QC Date

November 13, 2023

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Message Perceived Effectiveness - Persuasive Potential.

    6 items measured on 5-point scale, 1 = Not at all and 5 = Very much * These messages were worth remembering. * These messages grabbed my attention. * These messages are powerful. * These messages are convincing. * These messages are meaningful. * These messages are informative. Responses were summed and averaged to create a scale for intention to quit (range from 1 - 5). Higher scores indicate a higher persuasive potential of the message.

    Immediately post-exposure to intervention, up to 1 hour

  • Perceived Effectiveness - Perceived Behavioral Impact

    Six items were analyzed separately, each scored on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree) These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit.

    Immediately post-exposure to intervention, up to 1 hour

  • Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use

    On a scale from 0-10, where 0 = not at all harmful and 10 = extremely harmful now harmful are ... to your health? * combustible cigarettes * nicotine vapes On a scale from 0-10, where 0 = much less harmful and 10 = much more harmful... • compared to combustible cigarettes, how harmful are nicotine vapes to your health?

    Immediately post-exposure to intervention, up to 1 hour

  • Behavioral Intentions to Use Tobacco

    8-items made up two 4-pt scales (1 = definitely will not and 4 = definitely will). Items for each scale were summed and averaged. Higher scores indicate higher likelihood of avoiding cigarettes/nicotine vapes. How likely it is that in the next 3 months, you will refrain from... * smoking cigarettes completely and permanently? * smoking cigarettes when you get lonely? * smoking cigarettes when you are with your friends who use them? * smoking cigarettes when someone hands you a cigarette? How likely it is that in the next 3 months, you will refrain from... * vaping nicotine completely and permanently? * vaping nicotine when you get lonely? * vaping nicotine when you are with your friends who use them? * vaping nicotine when someone hands you a vape?

    Immediately post-exposure to intervention, up to 1 hour

Study Arms (7)

AR-Quit

EXPERIMENTAL

Participants view messages with absolute risk and quit statements

Other: Health communications

AR-Switch

EXPERIMENTAL

Participants view messages with absolute risk and switch statements

Other: Health communications

AR-Combination

EXPERIMENTAL

Participants view messages with absolute risk and combination quit+switch statements

Other: Health communications

RR-Quit

EXPERIMENTAL

Participants view messages with comparative risk and quit statements

Other: Health communications

RR-Switch

EXPERIMENTAL

Participants view messages with comparative risk and switch statements

Other: Health communications

RR-Combination

EXPERIMENTAL

Participants view messages with comparative risk and combination quit+switch statements

Other: Health communications

Control

OTHER

Participants view FDA regulatory messages

Other: Health communications

Interventions

Participants are assigned to view health communications with risk and efficacy statements.

AR-CombinationAR-QuitAR-SwitchControlRR-CombinationRR-QuitRR-Switch

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults (age 18-35 years)
  • Live in the United States
  • At least 50% of the sample also:
  • Are susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-cigarettes at least once)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Health Communication

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Joanne G. Patterson
Organization
The Ohio State University College of Public Health

Study Officials

  • Joanne G Patterson, PhD MPH MSW

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 26, 2022

Study Start

April 14, 2021

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

December 26, 2023

Results First Posted

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations