Behavior, Health Risk, Cessation, Smoking, E Cigarette Use, Engagement, Patient, Implementation Science, Incentives, Media Literacy, Peer Support
Conditions
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 specific aims: Aim 1. To assess the feasibility of a multi-component vaping cessation program; and Aim 2 To evaluate the preliminary effect 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.
Interventions
BEHAVIORALText-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.
BEHAVIORALFinancial incentive
1. 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) 2. 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). 3. 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
BEHAVIORALMedia 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.
Sponsors
University of Nebraska
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This study employs a pilot, 4-arm randomized clinical trial design.
Eligibility
Sex/Gender
ALL
Age
19 Years to 29 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement_remote checkin_3 | 3 months | Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3. |
| Retention | 3 months | The number of participants who completed the end-of-study assessment (Week 12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTzeyu Michaud, PhD
University of Nebraska
Participant flow
Recruitment details
We worked with READi Core at the University of Nebraska Medical Center to first generate a list of potentially eligible participants, filtering for age and using smart text data to determine the vaping or smoking status. A study invitation email was sent to individuals on this potential participant list . In this email, interested individuals will be directed to complete web-based screening questions via REDCap to assess their eligibility.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 23.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black | 6 Participants |
| Race/Ethnicity, Customized Other (e.g/., Asian or American Indian/Alaskan Native) | 0 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants |
| Race/Ethnicity, Customized White | 31 Participants |
| Region of Enrollment United States | 11 participants |
| Sex/Gender, Customized Female | 7 Participants |
| Sex/Gender, Customized Male | 1 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed