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

3 de junio de 2026 actualizado por: Fred Hutchinson Cancer Center

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • New Mexico
      • Las Cruces, New Mexico, Estados Unidos, 88003
        • Aún no reclutando
        • New Mexico State University
        • Contacto:
          • Tamara Stimatze, PhD
          • Número de teléfono: 575-646-4106
          • Correo electrónico: tstimatz@nmsu.edu
        • Investigador principal:
          • Tamara Stimatze, PhD
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Reclutamiento
        • Fred Hutch/University of Washington Cancer Consortium
        • Contacto:
        • Investigador principal:
          • Jaimee Heffner, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.
Otro: Administración de encuestas
Encuestas completas
Otro: Administración de encuestas
Encuesta completa
Otro: Smartphone app-based Intervention
Use LiFT A app
Otro: Smartphone app-based Intervention
Use LiFT B app
Otro: Communication intervention
Receive LiFT A text messages
Otro: 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.
Otro: Administración de encuestas
Encuestas completas
Otro: Administración de encuestas
Encuesta completa
Otro: Smartphone app-based Intervention
Use LiFT A app
Otro: Smartphone app-based Intervention
Use LiFT B app
Otro: Communication intervention
Receive LiFT A text messages
Otro: Communication intervention
Receive LiFT B text messages
Otro: 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.
Otro: Administración de encuestas
Encuestas completas
Otro: Administración de encuestas
Encuesta completa
Otro: Entrevista
Asistir a la entrevista
Otro: Smartphone app-based Intervention
Use LiFT A app
Otro: Smartphone app-based Intervention
Use LiFT B app
Otro: Assessment
Complete usability assessment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall satisfaction (Pilot trial phase)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At completion of post pilot trial diary study phase (At Day 9)
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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: At 3 months
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)
Periodo de tiempo: From baseline to 3 months
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)
Periodo de tiempo: From baseline to 3 months
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)
Periodo de tiempo: From baseline to 3 months
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)
Periodo de tiempo: From baseline to 3 months
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fred Hutchinson Cancer Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Jaimee Heffner, PhD, Fred Hutch/University of Washington Cancer Consortium

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RG1126140
  • U54CA132381 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2026-00801 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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