An Online Intervention to Reduce E-cigarette Use and Susceptibility to Smoking in Young Adults

Development of An Online, Theory-Based Intervention to Reduce E-cigarette Use and Susceptibility to Smoking in Young Adults: A Pilot Study

The goal of this intervention development and pilot clinical trial is to determine whether receiving the brief online intervention results in greater reductions in past 7-day e-cigarette use frequency and smoking susceptibility over an 8-week period compared to receiving the control condition in young adults who currently use e-cigarettes. Participants in the experimental condition will be asked to complete the 30-minute mobile-based program. Participants in the assessment-only control will be given the option to access the intervention after they complete their final survey at 8 weeks. All participants will complete our online surveys at baseline as well as 2-weeks, 4-weeks, and 8-weeks post-randomization. Researchers will compare outcomes among the intervention and control groups to determine the efficacy of the intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: E-cigarette Use
• Intervention / Treatment: Behavioral: Live Free From E-cigarettes

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shirin Contracts and Grants Coordinator; Phone Number: 310-918-0538; Email: shirin.mistry@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• be between the ages of 18 to 24
• be able to read English
• report vaping at least one day per week in the past month
• report no history of cigarette use at screening and baseline.

Exclusion Criteria:

• reporting mental health, other drug, or alcohol use problems
• currently receiving nicotine cessation services

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will be asked to complete a 30-minute intervention that is accessible on a mobile device, delivered via a webpage, and personalized to their individual vaping behavior and beliefs (based on the baseline surveys). The intervention will contain personalized normative feedback (PNF), Motivational Enhancement (ME), and education. Participants will complete assessments at baseline as well as 2-weeks, 4-weeks, and 8-weeks post randomization.	Behavioral: Live Free From E-cigarettes; This is a 30-minute online educational program that focuses on providing information about e-cigarette and smoking social norms, harms of e-cigarettes and cigarettes, and ways to quit or reduce using e-cigarettes.
No Intervention: Waitlist Control; Participants will complete assessments at baseline as well as 2-weeks, 4-weeks, and 8-weeks post randomization. They will not receive the intervention during the active study phase, lasting 8 weeks. Participants will have the option to access the intervention once this active study phase is over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-cigarette Use	Participants will report the number of (1) days they vaped, (2) times they picked up their device to vape per day, and (3) puffs they took before putting their vaping device away per day in the past 7 days and 30 days	8 weeks
Smoking Susceptibility	4-item Expanded Susceptibility to Smoking Index (ESSI)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived harms and benefits of vaping	Using the 21-item Short Form Vaping Consequences Questionnaire (S-VSQ), participants will rate the likelihood that each consequence will occur when they vape.	8 weeks
Perceived harms and benefits of smoking	Using the 21-item Short Form Smoking Consequences Questionnaire (S-SCQ), participants will rate the likelihood that each consequence will occur when they smoke.	8 weeks
Motivation to vape	Participants will select which option best describes their interest in e-cigarette use: plan to stop (coded as 1), decrease (2), continue (3) or increase (4) vaping.	8 weeks
Motivation to smoke	Participants will report if they plan to start smoking (yes/no).	8 weeks
Quitting vaping self-efficacy	Participants rate their confidence about quitting vaping "someday" and "in the next 6 months" on a 5-point scale.	8 weeks

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Denise D Tran, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility
• Other Study ID Numbers: UP-23-00005-AM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No identifying participant information will be shared with other researchers. In the case where another researcher requests access to our data, we will de-identify our data set before sharing these data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No