Financial and Social Incentive-based Approaches to Improve Vaping Cessation Program Reach, Engagement, and Effectiveness

Sponsor
University of Nebraska (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05586308
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH)
80
1
4
7
11.5

Study Details

Study Description

Brief Summary

This study aims to evaluate the effectiveness 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 reach, engagement, and eventually abstinence. The central hypothesis is that the behavioral economics informed intervention with social support and financial incentive would improve participant engagement and increase program effectiveness (i.e. vaping abstinence).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vaping cessation program
  • Behavioral: Financial incentive
  • Behavioral: Social support
N/A

Detailed Description

This project will evaluate the effectiveness 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 reach, engagement, and eventually abstinence with the following three aims: Aim 1. To assess the feasibility of multifacted interventions to improve vaping cessation program reach and retention. Aim 2 To evaluate the effectiveness of multifacted incentives interventions for achieving vaping abstinence. Aim 3. To evaluate the cost-effectiveness and health effects.

Eligible participants are young adults aged 19-29 who are self-identified as having asthma and are current vapers (i.e., has vaped for a minimum of 6 months for at least 25 of the previous 30 days).This study employs a pragmatic, 2-factorial randomized clinical trial design. Individuals who meet the eligibility criteria will be randomized (1:1:1:1) to receive one of the following interventions for 2-week (could be up to one-month if participants need more time) run-in period and two-month abstinence period:1) Control- Participants in this arm will receive no intervention other than vaping cessation program during the entire study period; 2) Financial incentive- Participants will receive financial incentive intervention and vaping cessation program; 3) Social support- Participants will receive social support and vaping cessation program; and 4) Financial incentive + social support- Participants will receive financial incentive, social support, and vaping cessation program. Regardless of intervention arms, all enrolled participants will receive a a series of cession-based education lessons (TEAM) developed by the research team and a SMS text-messaging program (This is Quitting).Participants will be followed through a 3-month study period up to including 1-month running period and 2-month abstinence period. All participants will be asked to provide the saliva cotinine sample at baseline and at the end of the study period. Participants who assigned to the financial incentive group and financial incentive + social support groups will provide extra two saliva continine 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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
This study employs a pragmatic, 2-factorial randomized clinical trial design.This study employs a pragmatic, 2-factorial randomized clinical trial design.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Financial and Social Incentive-based Approaches to Improve Vaping Cessation Program Reach, Engagement, and Effectiveness
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Control

No intervention other than vaping cessation program.

Behavioral: Vaping cessation program
Vaping cessation intervention consists of online education lessons and text-messaging support program. Education 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. 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: Financial incenitve

Participants will receive financial incentive intervention and vaping cessation program.

Behavioral: Vaping cessation program
Vaping cessation intervention consists of online education lessons and text-messaging support program. Education 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. 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 receive: $10 for completing each education e-module (up-to 5 sessions) $10 for completing This is Quitting registration and setting up the quit date Participants will earn $3 for each saliva cotinine sample submission regardless of positive or negative results after the quit day (an assessments at week2, week4, week6, and week 8, after the quit date) Participants will earn additional escalating rewards for each negative sample- $2 for week 2, $7 for week 4, $12 for week 6, and $17 for week 8 (2 months after the target quit date). The bonus starts at $2 and increase by $5 for each subsequent negative cotinine sample (i.e., $2, $7, $12, and $17). A reset contingency will be used. That is the reward amount will be returned back to original $2 if there is a missing or positive saliva cotinine sample

Active Comparator: Social support

Participants will receive social support and vaping cessation program.

Behavioral: Vaping cessation program
Vaping cessation intervention consists of online education lessons and text-messaging support program. Education 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. 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: Social support
Participants randomized to this arm will be asked to identify a family member or friend to be their support sponsor and be emailed a bi-weekly report on the participants engagement level in the vaping cession program, including education lessons completion, text-messaging support program registration, and cotinine sample submission and abstinence results. This sponsor will be sent a message with a brief introduction of the study and description of the role of being a support sponsor at the start of the study to do their best to support the participant in their progress during the study. If the participants would not be able to identify a support sponsor, the research team will appoint a peer coach (from the research team) to them. Peer coach will serve as the same function as the family/friend support sponsor. Peer coach will contact the participants at the baseline, 1-month, and 2-month followup timepoints and participants could reach out to them whenever needed.

Experimental: Financial incentive + social support

Participants will receive financial incentive, social support, and vaping cessation program.

Behavioral: Vaping cessation program
Vaping cessation intervention consists of online education lessons and text-messaging support program. Education 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. 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 receive: $10 for completing each education e-module (up-to 5 sessions) $10 for completing This is Quitting registration and setting up the quit date Participants will earn $3 for each saliva cotinine sample submission regardless of positive or negative results after the quit day (an assessments at week2, week4, week6, and week 8, after the quit date) Participants will earn additional escalating rewards for each negative sample- $2 for week 2, $7 for week 4, $12 for week 6, and $17 for week 8 (2 months after the target quit date). The bonus starts at $2 and increase by $5 for each subsequent negative cotinine sample (i.e., $2, $7, $12, and $17). A reset contingency will be used. That is the reward amount will be returned back to original $2 if there is a missing or positive saliva cotinine sample

Behavioral: Social support
Participants randomized to this arm will be asked to identify a family member or friend to be their support sponsor and be emailed a bi-weekly report on the participants engagement level in the vaping cession program, including education lessons completion, text-messaging support program registration, and cotinine sample submission and abstinence results. This sponsor will be sent a message with a brief introduction of the study and description of the role of being a support sponsor at the start of the study to do their best to support the participant in their progress during the study. If the participants would not be able to identify a support sponsor, the research team will appoint a peer coach (from the research team) to them. Peer coach will serve as the same function as the family/friend support sponsor. Peer coach will contact the participants at the baseline, 1-month, and 2-month followup timepoints and participants could reach out to them whenever needed.

Outcome Measures

Primary Outcome Measures

  1. Reach [4 months]

    The percent of participants 1) completing the education lessons and text message program registration, 2) percentage of participants completing setting up the quit date

  2. Engagement [8 months]

    Percentage of participants submitting the saliva sample at bi-weekly/monthly followups after the quit date

Secondary Outcome Measures

  1. Nicotine abstinence [8 months]

    Baseline and end-study saliva cotinine samples and bi-weekly/monthly saliva cotinine samples (after the target quit date for 2 month) will be obtained.

  2. Biomarkers of toxic exposures [8 months]

    Twenty participants will provide the urine sample at the baseline and final visits (2 months after the target quit date) at the study clinic. The biomarker classes may include: 1) cotinine and hydroxycotinine, and 2) creatinine.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tzeyu Michaud Omaha Nebraska United States 68132

Sponsors and Collaborators

  • University of Nebraska
  • National Institute of General Medical Sciences (NIGMS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tzeyu Michaud PhD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier:
NCT05586308
Other Study ID Numbers:
  • 0596-22-EP
  • U54GM115458
First Posted:
Oct 19, 2022
Last Update Posted:
Oct 19, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 19, 2022