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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone app-based Intervention

    Other intervention

    Use LiFT A app

  • Smartphone app-based Intervention

    Other intervention

    Use LiFT B app

  • Communication intervention

    Other intervention

    Receive LiFT A text messages

  • Communication intervention

    Other intervention

    Receive LiFT B text messages

  • Survey Administration

    Other intervention

    Complete surveys

  • Interview

    Other intervention

    Attend interview

  • Assessment

    Other intervention

    Complete usability assessment

  • Survey Administration

    Other intervention

    Complete survey

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: User-centered design and program development phase (interview) [Objective 1]No intervention 0 interventions
Group B: Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]Experimental treatment 3 interventions
Group C: Pilot phase, Arm II (LiFT B app, LiFT B text messages) [Objective 2]Experimental treatment 3 interventions
Group D: Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]Other 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 3 months
2

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.

Time frame
At 3 months
3

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.

Time frame
At 3 months
4

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.

Time frame
At 3 months

Secondary outcomes

1

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.

Time frame
At 3 months
2

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.

Time frame
At 3 months
3

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.

Time frame
At 3 months
4

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.

Time frame
At 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator