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

NCT07571018 | Not Yet Recruiting FDA Device

• 3 other identifiers: RG1126140NCI-2026-00801U54CA132381
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)

  At 3 months

• Self-reported 7-day PPA from all nicotine and tobacco use (Pilot trial phase)

  At 3 months

• Self-reported 30-day PPA (Pilot trial phase)

  At 3 months

• Cotinine-confirmed 30-day PPA (Pilot trial phase)

  At 3 months

• Average change in Contemplation Ladder scores (Pilot trial phase)

  From baseline to 3 months

Study Arms (4)

User-centered design and program development phase (interview) [Objective 1]

NO INTERVENTION

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

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: Smartphone app-based Intervention; Other: Communication intervention; Other: Survey Administration

Pilot phase, Arm II (LiFT B app, LiFT B text messages) [Objective 2]

EXPERIMENTAL

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: Smartphone app-based Intervention; Other: Communication intervention; Other: Survey Administration

Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]

OTHER

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: Smartphone app-based Intervention; Other: Interview; Other: Assessment; Other: Survey Administration

Interventions

Smartphone app-based Intervention OTHER

Use LiFT A app

Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]; Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]

Communication intervention OTHER

Receive LiFT A text messages

Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]

Survey Administration OTHER

Complete surveys

Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]; Pilot phase, Arm II (LiFT B app, LiFT B text messages) [Objective 2]

Interview OTHER

Attend interview

Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]

Assessment OTHER

Complete usability assessment

Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

New Mexico State University

Las Cruces, New Mexico, 88003, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Interviews as Topic; Restraint, Physical

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Jaimee Heffner, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaimee Heffner, PhD

CONTACT

206-667-7314; jheffner@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: PILOT TRIAL: Outcome evaluators who have contact with participants will remain blinded to treatment group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PILOT TRIAL: Parallel; USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: N/A; POST PILOT TRIAL DIARY STUDY: N/A

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)