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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzeyu Michaud, PhD; Phone Number: 402-836-9195; Email: tzeyu.michaud@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • Unversity of Nebraska Medical Center
      • Contact: Tzeyu Michaud, PhD; Phone Number: 402-836-9195; Email: tzeyu.michaud@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active control; Participants in this arm will receive an evidence-based text-messaging support.	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.
Active Comparator: Media literacy; Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.	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.; Behavioral: 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.
Active Comparator: Financial incentive; Participants will receive financial incentive intervention and an evidence-based text-messaging support.	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.; Behavioral: 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
Experimental: Combined; Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.	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.; Behavioral: 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.; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Media literacy	Media literacy will be measured by the vaping media literacy scale at baseline and end of study visits.	3 months
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
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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Tzeyu Michaud, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0596-22-EP; U54GM115458 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in vaping cessation program targeting youth/young adults. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a data transfer/use agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing/USE Agreement.
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

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