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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM115458 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active control | Other | Participants in this arm will receive an evidence-based text-messaging support. |
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| Media literacy | Active Comparator | Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support. |
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| Financial incentive | Active Comparator | Participants will receive financial incentive intervention and an evidence-based text-messaging support. |
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| Combined | Experimental | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text-massaging suport | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement_remote checkin_3 | Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3. | 3 months |
| Retention | The number of participants who completed the end-of-study assessment (Week 12). | 3 months |
| 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 |
| Self-reported Vaping Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tzeyu Michaud, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39983103 | Derived | Michaud T, Puga T, Archer R, Theye E, Zagurski C, Estabrooks P, Dai HD. Enhancing Text Message Support With Media Literacy and Financial Incentives for Vaping Cessation in Young Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 21;14:e60527. doi: 10.2196/60527. |
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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.
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
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Control | Participants in this arm will receive an evidence-based text-messaging support. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2024 |
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This study employs a pilot, 4-arm randomized clinical trial design.
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| Financial incentive | Behavioral |
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| Media literacy | Behavioral | 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. |
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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 |
| FG001 | Media Literacy | Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support. 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. 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. |
| FG002 | Financial Incentive | Participants will receive financial incentive intervention and an evidence-based text-messaging support. 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: 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 |
| FG003 | Combined | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Control | Participants in this arm will receive an evidence-based text-messaging support. 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. |
| BG001 | Media Literacy | Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support. 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. 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. |
| BG002 | Financial Incentive | Participants will receive financial incentive intervention and an evidence-based text-messaging support. 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: 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 |
| BG003 | Combined | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Engagement_remote checkin_3 | Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3. | Posted | Count of Participants | Participants | 3 months |
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| Primary | Retention | The number of participants who completed the end-of-study assessment (Week 12). | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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). | Posted | Count of Participants | Participants | 3 months |
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| 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. | Posted | Count of Participants | Participants | 3 months |
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Given that our study included only behavioral interventions (text message support, media literacy education, and financial incentives), we did not collect adverse events, as the risk associated with the interventions was minimal.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Control | Participants in this arm will receive an evidence-based text-messaging support. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Media Literacy | Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support. 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. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Financial Incentive | Participants will receive financial incentive intervention and an evidence-based text-messaging support. 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: 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Combined | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tzeyu Michaud | University of Nebraska Medical Center | 4028369195 | tzeyu.michaud@unmc.edu |
| Dec 8, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000073599 | Health Risk Behaviors |
| D000072137 | Vaping |
| D016540 | Smoking Cessation |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| Male |
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| Non-binary |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Other (e.g/., Asian or American Indian/Alaskan Native) |
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| Unknown |
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| Missing |
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| OG002 | Financial Incentive | Participants will receive financial incentive intervention and an evidence-based text-messaging support. 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: 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 |
| OG003 | Combined | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
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| OG002 | Financial Incentive | Participants will receive financial incentive intervention and an evidence-based text-messaging support. 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: 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 |
| OG003 | Combined | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
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| OG002 | Financial Incentive | Participants will receive financial incentive intervention and an evidence-based text-messaging support. 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: 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 |
| OG003 | Combined | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
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