Development and Pilot Evaluation of a Novel Mobile Health Intervention for Young Adult Tobacco Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Overall satisfaction (Pilot trial phase)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
PILOT TRIAL: Outcome evaluators who have contact with participants will remain blinded to treatment group assignment.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Smartphone app-based Intervention (Other)
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.
干预措施: Communication intervention (Other)
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.
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.
干预措施: Survey Administration (Other)
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.
干预措施: Smartphone app-based Intervention (Other)
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.
干预措施: Communication intervention (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Smartphone app-based Intervention (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Interview (Other)
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.
干预措施: Assessment (Other)
结局指标
主要结局
Overall satisfaction (Pilot trial phase)
时间窗: 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.
Number of logins to assigned application (Pilot trial phase)
时间窗: At 3 months
Treatment utilization will include number of logins to the assigned application, determined objectively using tracking software.
Usefulness of the program (Pilot trial phase)
时间窗: 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.
Usefulness of text messages (Pilot trial phase)
时间窗: 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.
Satisfaction with perceived tailoring (Pilot trial phase)
时间窗: 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.
Satisfaction with guidance on how to quit (Pilot trial phase)
时间窗: 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.
Perception that program offered a novel approach to quitting (Pilot trial phase)
时间窗: 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.
Perceived helpfulness for quit preparation (Pilot trial phase)
时间窗: 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.
Willingness to recommend program to a friend (Pilot trial phase)
时间窗: 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").
Usability (Post pilot trial diary study phase)
时间窗: 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.
次要结局
- Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)(At 3 months)
- Self-reported 7-day PPA from all nicotine and tobacco use (Pilot trial phase)(At 3 months)
- Self-reported 30-day PPA (Pilot trial phase)(At 3 months)
- Cotinine-confirmed 30-day PPA (Pilot trial phase)(At 3 months)
- Average change in Contemplation Ladder scores (Pilot trial phase)(From baseline to 3 months)
- Change in acceptance of tobacco use triggers (Pilot trial phase)(From baseline to 3 months)
- Change in values progress (Pilot trial phase)(From baseline to 3 months)
- Change in values obstruction (Pilot trial phase)(From baseline to 3 months)