Text Message Quit Vaping Intervention for Young Adults

May 17, 2022 updated by: Amanda L. Graham, PhD, Truth Initiative

A Randomized Trial of a Text Message Quit Vaping Intervention for Young Adults

This research study, conducted by Truth Initiative, will help us learn how text messaging can help young adults between 18 and 24 years of age quit vaping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Quit Vaping Study (QVS)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 18-24. This study is a 2-arm randomized controlled trial conducted among young users aged 18-24 recruited through online channels. Participants will be randomized to a quit vaping text message intervention or to an assessment-only control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.

Study Type

Interventional

Enrollment (Actual)

2588

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20001
        • Truth Initiative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-24
  • Past 30-day use of e-cigarettes containing nicotine
  • Interest in quitting e-cigarette use in the next 30 days
  • US residence

Exclusion Criteria:

  • Failure to confirm mobile number after initial sign-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: This is Quitting

Participants will be enrolled to receive messages from This is Quitting.

Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support.
Other: This is Quitting
Text message-based intervention for quit vaping support.
OTHER: Assessment only Control
After an initial enrollment message, participants will be contacted periodically to assess e-cigarette use. At the end of the intervention period, they will receive information on how to sign up for This is Quitting if they are interested in the program
Other: Assessment only Control
Assessment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT)
Time Frame: 7 months post enrollment
Number of participant who responded "No" to the question "In the past 30 days, did you vape at all, even a puff of someone else's?" Denominator is all randomized participants.
7 months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only)
Time Frame: 7 month post enrollment
Number of participants with who responded 'No" to the question "In the past 30 days, did you vape at all, even a puff of someone else's?" Denominator is participants with responses only.
7 month post enrollment
Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT)
Time Frame: 7 months post enrollment
Number of participants who responded "No" to the question "Have you used any vape, even one puff, in the past 7 days?" Denominator is all randomized participants.
7 months post enrollment
Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only)
Time Frame: 7 months post enrollment
Number of participants who responded "No" to the question "Have you used any vape, even one puff, in the past 7 days?" Denominator is those who responded to the question only.
7 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Truth Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2019

Primary Completion (ACTUAL)

November 12, 2020

Study Completion (ACTUAL)

November 12, 2020

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 31, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TruthInitiativeQVS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are not available to other researchers. For access to deidentified dataset, please contact study administrator for more information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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