Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation

Not Applicable

Active, not recruiting

• Conditions: Incentives; Media Literacy; Engagement, Patient; Implementation Science; Behavior, Health Risk; E Cigarette Use; Cessation, Smoking; Peer Support
• Interventions: Behavioral: Text-massaging suport; Behavioral: Media literacy; Behavioral: Financial incentive

• Registration Number: NCT05586308
• Lead Sponsor: University of Nebraska

Brief Summary

This study aims to evaluate the feasibility and compare the preliminary effect of vaping cessation program consisting of media literacy education and real-time text messaging support and leverage insights from behavioral economics to enhance social and financial incentives to improve program engagement, and eventually abstinence. Our hypotheses are that 1) the Combined arm is associated with improved vaping abstinence to the Media literacy and Financial incentive arms; and 2) the financial incentive-related arms (either Combined or Financial incentive) enhance engagement compared to the non-incentive related arms.

Detailed Description

The objective of this pilot study is to evaluate the feasibility and compare the potential effect of different vaping cessation intervention components in addition to evidence-based text-messaging support, including 1) media literacy interactive e-learning lessons, 2) financial incentives, and 3) combined (media literacy + financial incentive) on vaping abstinence among current young adult vapers over a three-month timeframe with the following three specific aims: Aim 1. To assess the feasibility of a multi-component vaping cessation program; Aim 2 To evaluate the preliminary effect of a multicomponent vaping cessation program; and exploratory Aim 3. To Examine the cost-consequence of a multicomponent vaping cessation program. Eligible participants are young adults aged 19-29 and are current vapers (i.e., has vaped in the previous 30 days).We will employ a 4-arm, feasibility randomized trial design to determine the preliminary effect of different vaping intervention components on vaping abstinence over a 3-month timeframe, consisting of a 1-month quitting preparation phase and 2-month abstinence phase. Eligible participants (n=80) will be randomized (in a 1:1:1:1 ratio), using a computer-generated algorithm, to to one of four vaping cessation interventions: 1) Active control: text-messaging support, 2) Media literacy: media literacy + text-messaging support, 3) Financial incentive: financial incentive + text-messaging support, and 4) Combined: media literacy e-learning lessons + financial incentive + text-messaging support, at the baseline visit. Regardless of intervention arms, all enrolled participants will receive receive an evidence-base text-messaging support program for quitting vaping (This is Quitting). Participants will be followed through a 3-month study period including a 1-month quitting preparation phase and a 2-month abstinence phase. All participants will be asked to provide the 5 saliva cotinine samples- at baseline and end-of-study visits and 3 at video calls (remote submissions). Participants who assigned to the financial incentive Combined groups will be provided monetary rewards for submitting saliva cotinine samples during the abstinence period. To examine the feasibility of biomarker testing for toxic exposures, for a subsample of 20 participants, a panel of biomarkers of toxic exposures will be measured at baseline and at the end of study.

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Study Start: 2023-12-07
• Primary Completion: 2024-11-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Aged 19-29
• Report vaping in the previous 30 days
• Have access to internet/video chat/SMS text message
• Are interested in quitting vaping in the next 30 days

Exclusion Criteria

• Must meet all the inclusion criteria
• Self-report as currently pregnant or planning to become pregnant in the next 3 months
• Already involved in vaping cession programs (either behavioral or medical intervention)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Media literacy	Media literacy	Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.
Financial incentive	Text-massaging suport	Participants will receive financial incentive intervention and an evidence-based text-messaging support.
Combined	Text-massaging suport	Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.
Combined	Financial incentive	Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.
Combined	Media literacy	Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.
Financial incentive	Financial incentive	Participants will receive financial incentive intervention and an evidence-based text-messaging support.
Active control	Text-massaging suport	Participants in this arm will receive an evidence-based text-messaging support.
Media literacy	Text-massaging suport	Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.

Primary Outcome Measures

Name	Time	Method
Biochemically verified vaping abstinence	3 months	Biochemically verified vaping abstinence (negative results- \< 30 ng/mL) will be measured by saliva cotinine samples at end of study (Week 12).

Secondary Outcome Measures

Name	Time	Method
Nicotine dependence index	3 months	Nicotine dependence index will be measured by the Penn State E-cigarette Dependence (PSECD) index at baseline and end-of-study
Self-reported vaping abstinence	3 months	Self-reported vaping abstinence will be assessed by the question "In the past 30 days, did you vape at all, even a puff of someone else?" at the end-of-study visit.
Engagement	3 months	Engagement will be assessed by: a) proportions of media literacy e-learning lessons completed at the end of the quitting preparation phase (Week 4), and b) proportions of participants who submitted the remote saliva cotinine sample at each scheduled time-point at end of study (Week 12);
Media literacy	3 months	Media literacy will be measured by the vaping media literacy scale at baseline and end of study visits.
Biomarkers of toxic exposures	3 months	Twenty participants will provide the urine sample at the baseline and end-of-study visits (2 months after the target quit date) at the study clinic. The biomarker classes may include: 1) cotinine and hydroxycotinine, and 2) creatinine.

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States