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

2026년 6월 3일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

140

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • New Mexico
      • Las Cruces, New Mexico, 미국, 88003
        • 아직 모집하지 않음
        • New Mexico State University
        • 연락하다:
        • 수석 연구원:
          • Tamara Stimatze, PhD
    • Washington
      • Seattle, Washington, 미국, 98109
        • 모병
        • Fred Hutch/University of Washington Cancer Consortium
        • 연락하다:
        • 수석 연구원:
          • Jaimee Heffner, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
실험적: 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.
다른: 설문조사 관리
설문 조사 완료
다른: 설문조사 관리
설문 조사 완료
다른: Smartphone app-based Intervention
Use LiFT A app
다른: Smartphone app-based Intervention
Use LiFT B app
다른: Communication intervention
Receive LiFT A text messages
다른: Communication intervention
Receive LiFT B text messages
실험적: 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.
다른: 설문조사 관리
설문 조사 완료
다른: 설문조사 관리
설문 조사 완료
다른: Smartphone app-based Intervention
Use LiFT A app
다른: Smartphone app-based Intervention
Use LiFT B app
다른: Communication intervention
Receive LiFT A text messages
다른: Communication intervention
Receive LiFT B text messages
다른: 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.
다른: 설문조사 관리
설문 조사 완료
다른: 설문조사 관리
설문 조사 완료
다른: 회견
면접 참석
다른: Smartphone app-based Intervention
Use LiFT A app
다른: Smartphone app-based Intervention
Use LiFT B app
다른: Assessment
Complete usability assessment

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall satisfaction (Pilot trial phase)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fred Hutchinson Cancer Center

협력자

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Jaimee Heffner, PhD, Fred Hutch/University of Washington Cancer Consortium

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 3일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RG1126140
  • U54CA132381 (미국 NIH 보조금/계약)
  • NCI-2026-00801 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

담배 관련 암종에 대한 임상 시험

설문조사 관리에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Benin

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다