A Novel Mobile Health Intervention for Improving Tobacco Cessation Among Young Adults
Status
Begins enrollment in 2 months
Conditions
Tobacco-Related Carcinoma
Treatments
Other: Smartphone app-based Intervention
Other: Communication intervention
Other: Survey Administration
Other: Assessment
Other: Interview
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
Tobacco use is the leading cause of preventable cancer deaths. Among young adults, approximately 1 in 5 use commercial nicotine and tobacco products, putting them at risk of developing nicotine addiction and long-term health effects from exposure to toxicants. Innovative approaches are needed to engage young adults in treatment, as they are less engaged in traditional treatment.
This clinical trial compares two versions of a mobile health intervention called Living Free from Tobacco (LiFT), designed to support nicotine and tobacco cessation among young adults. Both versions of the app are designed to motivate and support young adults to stop using nicotine and tobacco, regardless of current readiness to quit. Version A of the LiFT app (LiFT A) focuses on increasing psychological flexibility to support cessation, while Version B (LiFT B) provides educational content and resources related to tobacco use and cessation. Both versions of the program are delivered through a smartphone application and include accompanying text messages.
Full description
OUTLINE: Participants are assigned to 1 of 3 phases.
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT PHASE (Objective 1): Participants attend user testing interviews where they interact with LiFT application (app) prototypes and provide feedback through think-aloud methods to support refinement of the intervention content and features.
PILOT TRIAL PHASE (Objective 2): Participants are randomized to 1 of 2 arms.
- ARM I: Participants use the LiFT A app, which includes interactive games and exercises, educational content, and tools tailored to young adults using an acceptance and commitment therapy (ACT) treatment approach, for 3 months. Participants also receive associated text messages 2-3 times per week.
- ARM II: Participants use the LiFT B app, which includes educational resources on preparing to quit, nicotine withdrawal, coping with withdrawal, and mental health, along with health information videos, for 3 months. Participants also receive associated text messages 2-3 times per week.
POST PILOT TRIAL DIARY STUDY PHASE (Objective 3): Participants use the LiFT app and complete daily usability and satisfaction assessments for approximately 1 week. Participants also complete a survey and attend an interview.
Enrollment
140 estimated patients
Sex
All
Ages
18 to 30 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-identify being between 18 and 30 years of age
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must be a United States (US) resident, with a US mailing address
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must own a smartphone
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report having internet access for the interviews
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they have not participated in one of our prior tobacco cessation studies
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they understand and agree to the conditions of compensation
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they are not currently incarcerated
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must be willing and able to complete study procedures in English
- PILOT TRIAL: Participants must self-identify being between 18 and 30 years of age
- PILOT TRIAL: Participants must currently reside in the US and anticipate continued residence for the duration of the study (3 months)
- PILOT TRIAL: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening
- PILOT TRIAL: Participants must own an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
- PILOT TRIAL: Participants must self-report having at least weekly internet access for the next three months
- PILOT TRIAL: Participants must be willing and able to download an app to their phone and receive text messages
- PILOT TRIAL: Participants must self-report current use of a personal email account
- PILOT TRIAL: Participants must self-report current use of text messaging
- PILOT TRIAL: Participants must self-report that they are interested in participating in the study for themselves (vs someone else)
- PILOT TRIAL: Participants must self-report that they have not participated in one of our prior tobacco cessation studies
- PILOT TRIAL: Participants must self-report that they understand and agree to the conditions of compensation
- PILOT TRIAL: Participants must self-report that they are not currently incarcerated
- PILOT TRIAL: Participants must be willing to use the assigned intervention program, complete the study assessments, and complete an online consent form in English
- POST PILOT TRIAL DIARY STUDY: Participants must self-identify being between 18 and 30 years of age
- POST PILOT TRIAL DIARY STUDY: Participants must currently reside in the US
- POST PILOT TRIAL DIARY STUDY: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening
- POST PILOT TRIAL DIARY STUDY: Participants must own an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
- POST PILOT TRIAL DIARY STUDY: Participants must self-report having at least internet access for the duration of the diary study
- POST PILOT TRIAL DIARY STUDY: Participants must be willing and able to download an app to their phone and receive text messages
- POST PILOT TRIAL DIARY STUDY: Participants must self-report current use of a personal email account
- POST PILOT TRIAL DIARY STUDY: Participants must self-report current use of text messaging
- POST PILOT TRIAL DIARY STUDY: Participants must self-report that they are interested in participating in the study for themselves (vs someone else)
- POST PILOT TRIAL DIARY STUDY: Participants must self-report that they have not participated in one of our prior tobacco cessation studies
- POST PILOT TRIAL DIARY STUDY: Participants must self-report that they understand and agree to the conditions of compensation
- POST PILOT TRIAL DIARY STUDY: Participants must self-report that they are not currently incarcerated
- POST PILOT TRIAL DIARY STUDY: Participants must be willing to use the intervention program, complete the study assessments, and complete an online consent form in English
Exclusion criteria
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals must not be < 18 or > 30 years of age
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals must not have a Google voice number as their sole phone number
- USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals who are non-English speaking cannot participate, as this would prevent their participation in the interviews, which will be conducted in English
- PILOT TRIAL: Participants must not be < 18 or > 30 years of age
- PILOT TRIAL: Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
- PILOT TRIAL: Participants must not be a member of the same household as another research participant
- PILOT TRIAL: Participants must not have a Google voice number as their sole phone number
- PILOT TRIAL: Participants must not be identified as fraudulent per our fraud prevention protocol
- PILOT TRIAL: Participants must not be pregnant or plan on becoming pregnant over the next 3 months
- POST PILOT TRIAL DIARY STUDY: Individuals must not be < 18 or > 30 years of age
- POST PILOT TRIAL DIARY STUDY: Participants must not have a Google voice number as their sole phone number
- POST PILOT TRIAL DIARY STUDY: Individuals who are non-English speaking cannot participate, as this would prevent their participation in the interviews, which will be conducted in English
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
140 participants in 4 patient groups
User-centered design and program development phase (interview) [Objective 1]
No Intervention group
Description:
Participants attend user testing interviews where they interact with LiFT app prototypes and provide feedback through think-aloud methods to support refinement of the intervention content and features.
Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]
Experimental group
Description:
Participants use the LiFT A app, which includes interactive games and exercises, educational content, and tools tailored to young adults using an ACT treatment approach, for 3 months. Participants also receive LiFT A text messages 2-3 times per week.
Treatment:
Other: Communication intervention
Other: Survey Administration
Other: Survey Administration
Other: Communication intervention
Other: Smartphone app-based Intervention
Other: Smartphone app-based Intervention
Pilot phase, Arm II (LiFT B app, LiFT B text messages) [Objective 2]
Experimental group
Description:
Participants use the LiFT B app, which includes educational resources on preparing to quit, nicotine withdrawal, coping with withdrawal, mental health, along with health information videos, for 3 months. Participants also receive LiFT B text messages 2-3 times per week.
Treatment:
Other: Communication intervention
Other: Survey Administration
Other: Survey Administration
Other: Communication intervention
Other: Smartphone app-based Intervention
Other: Smartphone app-based Intervention
Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]
Other group
Description:
Participants use the LiFT app and complete daily usability and satisfaction assessments for approximately 1 week. Participants also complete a survey and attend an interview.
Treatment:
Other: Interview
Other: Assessment
Other: Survey Administration
Other: Survey Administration
Other: Smartphone app-based Intervention
Other: Smartphone app-based Intervention
Trial contacts and locations
2
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Central trial contact
Jaimee Heffner, PhD
Data sourced from clinicaltrials.gov
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