Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation
Primary Purpose
Behavior, Health Risk, Implementation Science, E Cigarette Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text-massaging suport
Financial incentive
Media literacy
Sponsored by
About this trial
This is an interventional treatment trial for Behavior, Health Risk
Eligibility Criteria
Inclusion Criteria:
- Aged 19-29
- Have an asthma diagnosis (ICD code of J45)
- Report vaping for a minimum of 6-months for at least 25 of the previous 30 days
- Have access to internet/video chat/SMS text message
- Report a desire to quit vaping
Exclusion Criteria:
- Must meet all the inclusion criteria
- Reported using any other nicotine products
- Already involved in vaping cession programs (either behavioral or medical intervention)
Sites / Locations
- Unversity of Nebraska Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Active Comparator
Active Comparator
Experimental
Arm Label
Active control
Media literacy
Financial incentive
Combined
Arm Description
Participants in this arm will receive an evidence-based text-messaging support.
Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.
Participants will receive financial incentive intervention and an evidence-based text-messaging support.
Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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);
Nicotine dependence index
Nicotine dependence index will be measured by the Penn State E-cigarette Dependence (PSECD) index at baseline and end-of-study
Media literacy
Media literacy will be measured by the vaping media literacy scale at baseline and end of study visits.
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.
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.
Full Information
NCT ID
NCT05586308
First Posted
October 14, 2022
Last Updated
October 7, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT05586308
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Health Risk, Implementation Science, E Cigarette Use, Cessation, Smoking, Incentives, Engagement, Patient, Peer Support, Media Literacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study employs a pilot, 4-arm randomized clinical trial design.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active control
Arm Type
Other
Arm Description
Participants in this arm will receive an evidence-based text-messaging support.
Arm Title
Media literacy
Arm Type
Active Comparator
Arm Description
Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.
Arm Title
Financial incentive
Arm Type
Active Comparator
Arm Description
Participants will receive financial incentive intervention and an evidence-based text-messaging support.
Arm Title
Combined
Arm Type
Experimental
Arm Description
Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.
Intervention Type
Behavioral
Intervention Name(s)
Text-massaging suport
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentive
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Media literacy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biochemically verified vaping abstinence
Description
Biochemically verified vaping abstinence (negative results- < 30 ng/mL) will be measured by saliva cotinine samples at end of study (Week 12).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Engagement
Description
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);
Time Frame
3 months
Title
Nicotine dependence index
Description
Nicotine dependence index will be measured by the Penn State E-cigarette Dependence (PSECD) index at baseline and end-of-study
Time Frame
3 months
Title
Media literacy
Description
Media literacy will be measured by the vaping media literacy scale at baseline and end of study visits.
Time Frame
3 months
Title
Self-reported vaping abstinence
Description
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.
Time Frame
3 months
Title
Biomarkers of toxic exposures
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzeyu Michaud, PhD
Phone
402-836-9195
Email
tzeyu.michaud@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzeyu Michaud, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzeyu Michaud, PhD
Phone
402-836-9195
Email
tzeyu.michaud@unmc.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation
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