Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

3 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

140

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • New Mexico
      • Las Cruces, New Mexico, Stany Zjednoczone, 88003
        • Jeszcze nie rekrutacja
        • New Mexico State University
        • Kontakt:
        • Główny śledczy:
          • Tamara Stimatze, PhD
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98109
        • Rekrutacyjny
        • Fred Hutch/University of Washington Cancer Consortium
        • Kontakt:
        • Główny śledczy:
          • Jaimee Heffner, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: 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.
Eksperymentalny: 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.
Inny: Administracja ankiet
Wypełnij ankiety
Inny: Administracja ankiet
Wypełnij ankietę
Inny: Smartphone app-based Intervention
Use LiFT A app
Inny: Smartphone app-based Intervention
Use LiFT B app
Inny: Communication intervention
Receive LiFT A text messages
Inny: Communication intervention
Receive LiFT B text messages
Eksperymentalny: 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.
Inny: Administracja ankiet
Wypełnij ankiety
Inny: Administracja ankiet
Wypełnij ankietę
Inny: Smartphone app-based Intervention
Use LiFT A app
Inny: Smartphone app-based Intervention
Use LiFT B app
Inny: Communication intervention
Receive LiFT A text messages
Inny: Communication intervention
Receive LiFT B text messages
Inny: 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.
Inny: Administracja ankiet
Wypełnij ankiety
Inny: Administracja ankiet
Wypełnij ankietę
Inny: Wywiad
Weź udział w rozmowie kwalifikacyjnej
Inny: Smartphone app-based Intervention
Use LiFT A app
Inny: Smartphone app-based Intervention
Use LiFT B app
Inny: Assessment
Complete usability assessment

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall satisfaction (Pilot trial phase)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fred Hutchinson Cancer Center

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Jaimee Heffner, PhD, Fred Hutch/University of Washington Cancer Consortium

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

6 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RG1126140
  • U54CA132381 (Grant/umowa NIH USA)
  • NCI-2026-00801 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak związany z paleniem tytoniu

Badania kliniczne na Administracja ankiet

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Japan

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj