AI-Enhanced App-based Intervention for Adolescent E-cigarette Cessation

NCT06965296 | Not Yet Recruiting

• 1 other identifier: 1R34CA287720-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental study is to test if a smartphone app can help adolescents aged 14-20 quit e-cigarettes. The main questions it aims to answer are:

• Can the app help adolescents manage cravings and increase their readiness to quit?
• Does the personalized and real-time support provided by the app improve their success in quitting e-cigarettes? Researchers will compare two groups: an immediate-intervention group that starts using the app right away and a delayed-intervention group that begins after three months, to see if the timing of app access influences outcomes in e-cigarette cessation. Participants will:
• Set personal goals and track their daily progress within the app.
• Use a real-time "urge" feature that provides immediate support during cravings.
• Engage with a chatbot for quick answers and motivational support around quitting. This study aims to create an accessible, personalized tool to help adolescents reduce or quit e-cigarette use, exploring its feasibility as a broader intervention model.

Conditions

Nicotine Dependence, Cigarettes

Keywords

Adolescent e-cigarette use; E-cigarette cessation; Smartphone app; Digital health intervention; Personalized health support

Outcome Measures

Primary Outcomes (1)

• Usability

  The usability of the intervention will be assessed using the mHealth App Usability Questionnaire, a 21-item instrument designed for interactive mobile health apps. It measures three domains: ease of use and satisfaction, system information arrangement, and usefulness. Each item is rated on a 5-point Likert scale, yielding a total score range of 21 to 105, with higher scores indicating better usability. An open-ended question will also be included at the end of the survey to gather suggestions for app improvement.

  30-Day Follow-up

Secondary Outcomes (7)

• Engagement - Frequency of App Use

  30-Day and 3-Month Follow-up

• Engagement - Minutes of App Use

  30-Day and 3-Month Follow-up

• E-cigarette Use

  30-day and 3-month follow up

• Quit attempts

  30-Day and 3-Month Follow-up

• Readiness to Quit

  30-Day and 3-Month Follow-up

Study Arms (2)

Immediate-Intervention Group

EXPERIMENTAL

Participants in this arm will begin using the AI-enhanced smartphone app immediately after enrollment. This arm serves to assess the initial impact and feasibility of the app as a tool for e-cigarette cessation among adolescents.

Behavioral: AI-enhanced smartphone app

Delayed-Intervention Group

ACTIVE COMPARATOR

Participants in this arm will wait three months after enrollment before using the AI-enhanced smartphone app. This arm serves as a delayed control, allowing comparison with the immediate-intervention group to understand the impact of timing on quitting success.

Behavioral: AI-enhanced smartphone app, but with delayed access

Interventions

AI-enhanced smartphone app, but with delayed access BEHAVIORAL

Participants in the control group will be placed on a three-month waitlist. After this period, they will receive access to the same app-based intervention as the immediate intervention group, allowing a comparison between immediate and delayed access.

Delayed-Intervention Group

AI-enhanced smartphone app BEHAVIORAL

A smartphone app has been developed and is in keeping with guideline recommendations for the treatment of e-cigarette products. This app has a user-friendly Graphic User Interface (GUI) to allow users to build their own accounts and individualized contents conveniently, based on the input the users initially provide including e-cigarette use patterns, readiness to quit e-cigarette, beliefs about e-cigarette, nicotine addiction, self-efficacy, other substance use status, and parental or peer e-cigarette use status. The proposed AI model in this app will learn information from the input data, including progress toward e-cigarette cessation (e,g, changes of readiness of quitting, quit attempts), and additional data including emotional status, stress level, feedback to the previous learning modules, and then predict the result on the fly. Based on the predicted result, the app will send in-time motivational messages and mindfulness training modules.

Immediate-Intervention Group

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents who are 14 to 20 years old
• Currently use nicotine-containing e-cigarettes (those responding "Yes" to: Have you used an electronic vaping product such as PuffBar, ElfBar, Lost Mary, JUUL, Vuse, e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, or mods at least 1 day in the last 30 days? \[CDC, 2020\])
• Interested in participating in an e-cigarette use cessation program
• Owners of an iPhone or Android smartphone who use their phone daily
• Able to read English

You may not qualify if:

• Individuals who fall outside the age range of 14 to 20 years
• Those who have not used a nicotine-containing e-cigarette in the past 30 days
• Individuals not interested in participating in an e-cigarette cessation program
• Adolescents who do not own or regularly use an iPhone or Android smartphone
• Non-English speakers

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Advanced Bionics: collaborator
• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo, School of Nursing

Buffalo, New York, 14214, United States

Location

Related Publications (5)

• Hebert ET, Ra CK, Alexander AC, Helt A, Moisiuc R, Kendzor DE, Vidrine DJ, Funk-Lawler RK, Businelle MS. A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Mar 9;22(3):e16907. doi: 10.2196/16907.

  PMID: 32149716 BACKGROUND

• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

  PMID: 29403314 BACKGROUND

• Baskerville NB, Struik LL, Guindon GE, Norman CD, Whittaker R, Burns C, Hammond D, Dash D, Brown KS. Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 23;6(10):e10893. doi: 10.2196/10893.

  PMID: 30355563 BACKGROUND

• Audrain-McGovern J, Rodriguez D, Pianin S, Alexander E. Initial e-cigarette flavoring and nicotine exposure and e-cigarette uptake among adolescents. Drug Alcohol Depend. 2019 Sep 1;202:149-155. doi: 10.1016/j.drugalcdep.2019.04.037. Epub 2019 Jul 19.

  PMID: 31351341 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Eunhee Park, PhD, RN, APHN-BC

CONTACT

716-829-3701; eunheepa@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study involves two groups: an immediate-intervention group that starts using the app immediately and a delayed-intervention group that begins after three months. Each group is assigned to its respective intervention timeline at the start and follows it independently of the other group, without switching or crossover.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: May 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)