Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults

NCT ID: NCT06395415

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2026-02-28

Brief Summary

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Electronic Nicotine Delivery Systems (ENDS) use remains prevalent among young adults, and many have high interest in quitting, yet research on effective intervention is lacking. A mobile health (mHealth) intervention that translates effective smoking cessation materials and pharmacotherapy may be a promising avenue for intervention. The initial phase of the proposed study uses a pilot study to evaluate a novel mHealth intervention for young adult ENDS and dual product (ENDS and combustible cigarette) users.

Detailed Description

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Conditions

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Electronic Nicotine Delivery Systems Tobacco Products Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mobile health (mHealth)

Participants in this arm will receive a 6-week mHealth message based intervention through their smartphone. They will also have the option of requesting free nicotine replacement therapy (NRT) throughout the treatment period.

Group Type EXPERIMENTAL

EQUIP

Intervention Type BEHAVIORAL

The intervention is delivered directly to participants' mobile phones using the Insight® platform, which allows for the implementation of assessments and interventions. Insight has been used in prior mHealth studies and allows for the delivery of tailored content based on parameters, such as intervention stage. The intervention has two stages: 1) Motivational enhancement (weeks 1-2) and 2) Skills and information (weeks 3-6). The first stage of messages will utilize personalized feedback and motivational interviewing prompts, while the second stage will provide health information on ENDS and skills, such as deep breathing. Content is tailored to motivation level (low/medium or high) and dual use status.

Standard care

Participants in this arm will receive a 5-10 minute walk-through of electronic nicotine delivery system (ENDS) and tobacco education and skills based on the most recent evidence. They will also have the options of requesting a sample of NRT.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Those in the standard advice group will be given offered a sample of NRT, instruction on its use, and will be encouraged to use in conjunction with standard web-based resources on ENDS and cessation over the course of a ten minute walk-through with study staff.

Interventions

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EQUIP

The intervention is delivered directly to participants' mobile phones using the Insight® platform, which allows for the implementation of assessments and interventions. Insight has been used in prior mHealth studies and allows for the delivery of tailored content based on parameters, such as intervention stage. The intervention has two stages: 1) Motivational enhancement (weeks 1-2) and 2) Skills and information (weeks 3-6). The first stage of messages will utilize personalized feedback and motivational interviewing prompts, while the second stage will provide health information on ENDS and skills, such as deep breathing. Content is tailored to motivation level (low/medium or high) and dual use status.

Intervention Type BEHAVIORAL

Standard Care

Those in the standard advice group will be given offered a sample of NRT, instruction on its use, and will be encouraged to use in conjunction with standard web-based resources on ENDS and cessation over the course of a ten minute walk-through with study staff.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18-26 years old, ability to understand the English language, willing and able to provide informed consent
2. Current ENDS user (at least 4 out of 7 days per week of use for the past one month); for focus groups, at least half of participants will report current cigarette smoking (at least 1 cigarette per day on at least 1 day per week in the past month)
3. Report interest in quitting or reducing ENDS (at least 6/10 scale in interest of quitting or reducing
4. Does not currently (in past one year) meet criteria for major psychiatric disorder including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
5. For women, not currently pregnant, planning to become pregnant, or breastfeeding due to lack of information on ENDS use and possible harms from NRT during pregnancy
6. Not currently using smoking cessation medication (i.e., Varenicline, Bupropion
7. No history of adverse reactions to nicotine replacement therapy

Exclusion Criteria

1. Does not own a mobile phone or is unwilling to receive text messages to their device
2. No interest in quitting or reducing use of ENDS
3. Uses electronic cigarettes less than 4 days per week in the past month
4. Reports past-year serious psychiatric illness, including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
5. Is currently using smoking cessation medication including Varenicline or Bupropion
6. Are a female who is currently pregnant or nursing or planning to become pregnant within the next 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago BREATHE Laboratory

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emma Brett, PhD

Role: CONTACT

Phone: 773-834-5341

Email: [email protected]

Facility Contacts

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Emma Dr. Brett

Role: primary

Other Identifiers

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IRB21-1839

Identifier Type: -

Identifier Source: org_study_id