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

2026年6月3日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

140

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • New Mexico
      • Las Cruces、New Mexico、アメリカ、88003
        • まだ募集していません
        • New Mexico State University
        • コンタクト：
        • 主任研究者：
          • Tamara Stimatze, PhD
    • Washington
      • Seattle、Washington、アメリカ、98109
        • 募集
        • Fred Hutch/University of Washington Cancer Consortium
        • コンタクト：
        • 主任研究者：
          • Jaimee Heffner, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし：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.
実験的：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.
他の：アンケート管理
調査を完了する
他の：アンケート管理
調査を完了する
他の：Smartphone app-based Intervention
Use LiFT A app
他の：Smartphone app-based Intervention
Use LiFT B app
他の：Communication intervention
Receive LiFT A text messages
他の：Communication intervention
Receive LiFT B text messages
実験的：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.
他の：アンケート管理
調査を完了する
他の：アンケート管理
調査を完了する
他の：Smartphone app-based Intervention
Use LiFT A app
他の：Smartphone app-based Intervention
Use LiFT B app
他の：Communication intervention
Receive LiFT A text messages
他の：Communication intervention
Receive LiFT B text messages
他の：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.
他の：アンケート管理
調査を完了する
他の：アンケート管理
調査を完了する
他の：インタビュー
面接に参加する
他の：Smartphone app-based Intervention
Use LiFT A app
他の：Smartphone app-based Intervention
Use LiFT B app
他の：Assessment
Complete usability assessment

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall satisfaction (Pilot trial phase)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fred Hutchinson Cancer Center

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Jaimee Heffner, PhD、Fred Hutch/University of Washington Cancer Consortium

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年4月30日

QC基準を満たした最初の提出物

2026年4月30日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • RG1126140
  • U54CA132381 (米国 NIH グラント/契約)
  • NCI-2026-00801 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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