- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05958667
Quitxt Mobile Text Messaging Cessation Research Study
Randomized Controlled Trial to Assess Innovative Smoking Cessation Services for Young Adults in Texas
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Chalela, DrPH
- Phone Number: (210) 562-6513
- Email: chalela@uthscsa.edu
Study Contact Backup
- Name: Vivian Cortez, MS
- Phone Number: (210) 562-6528
- Email: cortezv1@uthscsa.edu
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Recruiting
- The University of Texas Health Science Center at San Antonio
-
Contact:
- Patricia Chalela, DrPH
- Phone Number: 210-562-6513
- Email: chalela@uthscsa.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Latinos
- aged 18-29 years;
- smoking at least one cigarette/day ≥3 days/week;
- interested in quitting;
- willing to provide follow-up data;
- are not simultaneously participating in a cessation program;
- own a cell phone or smartphone;
- are able to send and receive text messages and access the Internet;
- reside in the study area; and
- able to provide informed consent to participate in the study.
Exclusion Criteria:
- are not interested in quitting;
- are unable to provide consent due to a mental, emotional, or physical handicap that keep them from understanding the consent information;
- do not own a cell phone with text and Internet capabilities;
- are unable to respond to text messages and questions or unable to view the study mobile webpages/YouTube videos (i.e., if they are blind, deaf); or
- are planning to move from the study area within the study time span.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quitxt bilingual text messaging and chat
Culturally and linguistically tailored, bilingual text messaging or chat mobile app. Our text messaging or chat intervention will include messaging options in which users can text or message a code when they are craving a cigarette or at risk of relapse and immediately receive text or social media messages to help them avoid smoking. The social media content also will include opportunities for users to repeatedly visit key content pages and receive immediate support when experiencing cravings, stress, bad mood, or when feeling at risk of smoking. |
Mobile intervention using proven social cognitive, motivational interviewing, and brief intervention methods for promoting behavior change - blends bilingual text and social media messaging for smoking cessation tailored to the language and culture of young adult smokers in our vulnerable region of South Texas.
Other Names:
|
|
Other: Usual care
Abbreviated text messaging with smoking cessation-related content and referral to the Texas Department of State Health Services (TDSHS) cessation program Yes Quit (www.yesquit.org)
available to smokers seeking help quitting.
The abbreviated text messaging will include general information on smoking harms and benefits of cessation, and baseline data collection and follow-up assessments.
|
Abbreviated text messaging with smoking cessation-related content and referral to the Texas Department of State Health Services (TDSHS) cessation program Yes Quit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking cessation
Time Frame: 6 months
|
Measure of smoking cessation (7-day point prevalence abstinence)self-reported and biochemically verified.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking cessation assessment
Time Frame: 1 month and 3 months
|
Measure of smoking cessation (7-day point prevalence abstinence)self-reported and biochemically verified.
|
1 month and 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patricia Chalela, DrPH, The University of Texas Health Science Center at San Antonio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20230473H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Annual presentation at a national conference is expected. Community Presentations/Forums for young adult organizations and groups, public health and clinical practitioners, and the community at large.
Educational presentations and infographics about the importance of quitting smoking aimed at colleges, technical schools, community stakeholders, at health fairs or at in-person and/or virtual educational sessions organized with the study team's community partners.
Submission to scientific journals Communications, American Journal of Health Promotion, Tobacco Control, and other scientific periodicals to disseminate findings including Quitxt text messaging and chat development and implementation and report experimental results based on follow-up assessments.
Via the Institute for Health Promotion Research home website; its institutional e-newsletters; and its Salud America! (SA!) national network.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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