Clinical trial NCT05958667: Quitxt Mobile Text Messaging Cessation Research Study
Official title: Randomized Controlled Trial to Assess Innovative Smoking Cessation Services for Young Adults in Texas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Quitxt
Young adults
Latinos
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
name: The University of Texas at San Antonio
First posted: 2023-07-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-group parallel randomized controlled trial with 1,200 Spanish- and English-speaking young Latino adult smokers in South Texas (ages 18-29) to assess the effects of Quitxt on smoking cessation.
Primary purpose: PREVENTION

Brief summary: The health benefits of smoking cessation by age 30 are much greater than cessation later in life, including gaining 10 years of life, compared with those who continue to smoke. The goal of the proposed study is to evaluate the effectiveness of the bilingual and culturally tailored Quitxt mobile cessation intervention. Quitxt provides interactive messages through texts or chat with visual and video content employing theory- and evidence-based techniques to prompt and sustain cessation. The study will recruit 1,200 Latino young adult smokers aged 18-29 who enroll and agree to make quit attempts, with half randomly assigned (like flipping a coin) to receive Quitxt and half to abbreviated text messages with smoking cessation-related content and referral to the Texas Department of State Health Services cessation program Yes Quit (which has diverse formats, but not explicitly tailored for young Latino adults in South Texas). Participants respond to baseline and follow-up assessments at one, three and six months after their enrollment, and those who report cessation will be asked to provide saliva samples to confirm they quit smoking. The sample size will be sufficient to detect expected higher cessation rates in those who are enrolled in Quitxt than those who are enrolled in Texas DSHS Yes Quit. The investigators will publish results in scientific journals, report them at scientific and community meetings, share them on social media, and publicize them widely. This study has the potential to advance public health by evaluating the effectiveness of a scalable, easily disseminated and adaptable intervention to help young adults, especially Latinos, quit smoking and reduce smoking-related cancer and chronic disease morbidity and mortality and their associated healthcare costs.

Detailed description: Despite major advances in tobacco control and treatment, tobacco use remains the single largest preventable cause of morbidity and mortality in the US. Smoking prevalence is highest among Texas young adults (ages 18-29) and even higher among those with less than a high-school education and those living in rural areas and at or below the poverty level, such as Latinos. About 19.2% of Latinos ages 18-29 in the study areas are current smokers placing them at higher risk of cancer and other tobacco-related morbidity and mortality. Young adults are heavy users of smartphones, text messaging, social media chats and other mobile social media, providing a remarkable opportunity for innovation in the delivery of health promotion services to reduce health disparities in this large and rapidly growing racial/ethnic population. New social media have an extraordinary theoretical potential for assisting smoking cessation by providing peer modeling and eliciting social reinforcement for behavior change. The goal of this project is to experimentally evaluate Quitxt, a culturally appropriate mobile smoking cessation program. Quitxt - launched by an interdisciplinary research team 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 the vulnerable region of South Texas. Quitxt has not been tested in a research study, as its creation as an evidence-based cancer prevention service for young adult smokers was supported by the Cancer Prevention and Research Institute of Texas (CPRIT). To study the effects of Quitxt, the study team will recruit 1,200 young adult (ages 18-29) Latino Spanish- and English-speaking smokers over the 5-year study interval in South Texas. A two-group parallel randomized controlled trial will be conducted to compare rates of smoking cessation: 1) the intervention group will receive the innovative Quitxt text messaging or the chat mobile service; and 2) the usual care group will receive 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). The investigators will measure effects online at time of enrollment and again at one, three and six months later. The investigators will validate reports of smoking cessation via biological tests, for those who report smoking cessation at one, three and six-month follow-ups. The investigators hypothesize that the group receiving the Quitxt intervention will achieve significantly higher smoking cessation rates than the group receiving usual care. This study will expand research on the health of young adult Latinos by testing an innovative, mobile, culturally, and linguistically appropriate intervention to reduce smoking among young adult Latino smokers by enhancing their skills development, competence, and self-efficacy to initiate and maintain cessation. Moreover, this study will advance public health by testing the effectiveness of a scalable, evidence-based, easily disseminated, and adaptable intervention with potentially broad national reach to help young adults stop smoking and reduce smoking-related cancer and chronic disease morbidity and mortality and their associated healthcare costs.

Eligibility criteria: Inclusion Criteria:

1. Latinos
2. aged 18-29 years;
3. smoking at least one cigarette/day ≥3 days/week;
4. interested in quitting;
5. willing to provide follow-up data;
6. are not simultaneously participating in a cessation program;
7. own a cell phone or smartphone;
8. are able to send and receive text messages and access the Internet;
9. reside in the study area; and
10. able to provide informed consent to participate in the study.

Exclusion Criteria:

1. are not interested in quitting;
2. are unable to provide consent due to a mental, emotional, or physical handicap that keep them from understanding the consent information;
3. do not own a cell phone with text and Internet capabilities;
4. 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
5. are planning to move from the study area within the study time span.

Primary outcomes:
measure: Smoking cessation
timeFrame: 6 months
Secondary outcomes:
measure: Smoking cessation assessment
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Patricia Chalela, DrPH
role: PRINCIPAL_INVESTIGATOR
References: