A Novel Mobile Health Intervention for Improving Tobacco Cessation Among Young Adults

Development and Pilot Evaluation of a Novel Mobile Health Intervention for Young Adult Tobacco Cessation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Survey Administration; Other: Interview; Other: Smartphone app-based Intervention; Other: Smartphone app-based Intervention; Other: Communication intervention; Other: Communication intervention; Other: Assessment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaimee Heffner, PhD; Phone Number: 206-667-7314; Email: jheffner@fredhutch.org

Study Locations

• United States
  • New Mexico
    • Las Cruces, New Mexico, United States, 88003
      • New Mexico State University
      • Contact: Tamara Stimatze, PhD; Phone Number: 575-646-4106; Email: tstimatz@nmsu.edu
      • Principal Investigator: Tamara Stimatze, PhD
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Jaimee Heffner, PhD; Phone Number: 206-667-7314; Email: jheffner@fredhutch.org
      • Principal Investigator: Jaimee Heffner, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: User-centered design and program development phase (interview) [Objective 1]; 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.
Experimental: Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]; 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.	Other: Survey Administration; Complete surveys; Other: Survey Administration; Complete survey; Other: Smartphone app-based Intervention; Use LiFT A app; Other: Smartphone app-based Intervention; Use LiFT B app; Other: Communication intervention; Receive LiFT A text messages; Other: Communication intervention; Receive LiFT B text messages
Experimental: Pilot phase, Arm II (LiFT B app, LiFT B text messages) [Objective 2]; 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.	Other: Survey Administration; Complete surveys; Other: Survey Administration; Complete survey; Other: Smartphone app-based Intervention; Use LiFT A app; Other: Smartphone app-based Intervention; Use LiFT B app; Other: Communication intervention; Receive LiFT A text messages; Other: Communication intervention; Receive LiFT B text messages
Other: Post pilot trial diary study phase (LiFT, survey, interview) [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.	Other: Survey Administration; Complete surveys; Other: Survey Administration; Complete survey; Other: Interview; Attend interview; Other: Smartphone app-based Intervention; Use LiFT A app; Other: Smartphone app-based Intervention; Use LiFT B app; Other: Assessment; Complete usability assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction (Pilot trial phase)	Overall satisfaction with the assigned program will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Number of logins to assigned application (Pilot trial phase)	Treatment utilization will include number of logins to the assigned application, determined objectively using tracking software.	At 3 months
Usefulness of the program (Pilot trial phase)	The perceived usefulness of the assigned program will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Usefulness of text messages (Pilot trial phase)	The perceived usefulness of the assigned program's text messages will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Satisfaction with perceived tailoring (Pilot trial phase)	The perception that the assigned program was made for someone like the participant will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Satisfaction with guidance on how to quit (Pilot trial phase)	The perception that the program clarified how to quit nicotine/tobacco when ready will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Perception that program offered a novel approach to quitting (Pilot trial phase)	The perception that the program offered a new way of looking at quitting will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Perceived helpfulness for quit preparation (Pilot trial phase)	The perception that the program will help with quitting if/when ready will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.	At 3 months
Willingness to recommend program to a friend (Pilot trial phase)	Whether the respondent would recommend the program to a friend will be assessed via responses of "yes," "no," or "not sure." Responses will be categorized into a binary variable representing "yes" versus other responses (i.e.,"no" or "not sure").	At 3 months
Usability (Post pilot trial diary study phase)	Qualitative data from interviews, diary entries and exit interviews will be coded and analyzed using rapid inductive content analysis to extract themes. Usability data will be reported using descriptive statistics and compared against the benchmark score of 68, which represents average usability.	At completion of post pilot trial diary study phase (At Day 9)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)	Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 7 days, biochemically confirmed via saliva cotinine.	At 3 months
Self-reported 7-day PPA from all nicotine and tobacco use (Pilot trial phase)	Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 7 days.	At 3 months
Self-reported 30-day PPA (Pilot trial phase)	Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 30 days.	At 3 months
Cotinine-confirmed 30-day PPA (Pilot trial phase)	Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 30 days, biochemically confirmed via saliva cotinine.	At 3 months
Average change in Contemplation Ladder scores (Pilot trial phase)	The outcome will be calculated as the 3-month follow-up minus baseline score on the 11-point Contemplation Ladder. Positive change scores indicate increases in readiness to quit, on average, whereas negative change scores indicate decreases in readiness to quit.	From baseline to 3 months
Change in acceptance of tobacco use triggers (Pilot trial phase)	This outcome will be calculated as the 3-month follow-up minus baseline score on the cravings subscale of the Avoidance and Inflexibility Scale. Because avoidance and inflexibility represent the inverse of acceptance, positive change scores indicate a decrease in acceptance, on average, whereas negative change scores indicate increased acceptance of tobacco use triggers.	From baseline to 3 months
Change in values progress (Pilot trial phase)	This outcome will be calculated as the 3-month follow-up minus baseline score the progress subscale of the Valuing Questionnaire. Positive change scores indicate increases in values progress, on average, whereas negative change scores indicate decreases in values progress.	From baseline to 3 months
Change in values obstruction (Pilot trial phase)	This outcome will be calculated as the 3-month follow-up minus baseline score the values obstruction subscale of the Valuing Questionnaire. Positive change scores indicate increases in values obstruction, on average, whereas negative change scores indicate decreases in values obstruction.	From baseline to 3 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jaimee Heffner, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavior Control; Immobilization; Interviews as Topic; Restraint, Physical
• Other Study ID Numbers: RG1126140; U54CA132381 (U.S. NIH Grant/Contract); NCI-2026-00801 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes