Clinical trial NCT05586308: Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation
Official title: Pilot Study of Incentive-based and Media Literacy-informed Approaches to Improve Vaping Cessation Among Young Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavior, Health Risk
Implementation Science
E Cigarette Use
Cessation, Smoking
Incentives
Engagement, Patient
Peer Support
Media Literacy
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a pilot, 4-arm randomized clinical trial design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Biochemically verified vaping abstinence
timeFrame: 3 months
Secondary outcomes:
measure: Engagement
timeFrame: 3 months
measure: Nicotine dependence index
timeFrame: 3 months
measure: Media literacy
timeFrame: 3 months
measure: Self-reported vaping abstinence
timeFrame: 3 months
measure: Biomarkers of toxic exposures
timeFrame: 3 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Tzeyu Michaud, PhD
role: PRINCIPAL_INVESTIGATOR
References: