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

Implementation Science Clinical Trial

Official title:

Pilot Study of Incentive-based and Media Literacy-informed Approaches to Improve Vaping Cessation Among Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586308
• Other study ID #: 0596-22-EP
• Secondary ID: U54GM115458
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2023
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: Tzeyu Michaud, PhD
• Phone: 402-836-9195
• Email: tzeyu.michaud[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 29 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cessation, Smoking
• E Cigarette Use
• Engagement, Patient
• Implementation Science
• Incentives
• Peer Support

Intervention

Behavioral:
• Text-massaging suport
Text-messaging quitting support program (i.e., This is Quitting) is an evidence-based, free mobile program from Truth Initiative designed to help young people quit vaping. The program is fully automated and interactive. To establish or reinforce perceived social norms and social support around quitting, a majority of messages come from other users who have submitted them to the program.
• Financial incentive
Participants will earn $3 for each saliva cotinine sample submission regardless of positive or negative results after the quit day (an assessments at Week 6, Week 8, Week 10, and Week 12, during the abstinence phase) Participants will earn additional escalating rewards for each negative sample- $7 for Week 6, $12 for Week 8, $17 for Week 10, and $22 for Week 12 (2 months after the target quit date). The bonus starts at $7 and increase by $5 for each subsequent negative cotinine sample (i.e., $7, $12, $17, and $22). A reset contingency will be used. That is the reward amount will be returned back to original $7 if there is a missing or positive saliva cotinine sample
• Media literacy
Media literacy e-learning lessons cover topics regarding what e-cigarettes are and how they work, how nicotine and nicotine addiction affects the brain and behavior, how to prepare to quit vaping, developing a quit plan and how to deal with cravings and relapse. The program focuses on changing knowledge, attitudes and beliefs related to e-cigarette use, as well as emphasizing vaping related media literacy.

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically verified vaping abstinence	Biochemically verified vaping abstinence (negative results- < 30 ng/mL) will be measured by saliva cotinine samples at end of study (Week 12).	3 months
Secondary	Engagement	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);	3 months
Secondary	Nicotine dependence index	Nicotine dependence index will be measured by the Penn State E-cigarette Dependence (PSECD) index at baseline and end-of-study	3 months
Secondary	Media literacy	Media literacy will be measured by the vaping media literacy scale at baseline and end of study visits.	3 months
Secondary	Self-reported vaping abstinence	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.	3 months
Secondary	Biomarkers of toxic exposures	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.	3 months