Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-26
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-26 years old, ability to understand the English language, willing and able to provide informed consent
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)
Report interest in quitting or reducing ENDS (at least 6/10 scale in interest of quitting or reducing
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
Disqualifiers
Does not own a mobile phone or is unwilling to receive text messages to their device
No interest in quitting or reducing use of ENDS
Uses electronic cigarettes less than 4 days per week in the past month
Reports past-year serious psychiatric illness, including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
Trial design
Design model
Parallel
Treatments tested in this trial
EQUIP
BehavioralThe 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
BehavioralThose 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: mobile health (mHealth)Experimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ENDS cessation
ENDS cessation will be measured using a modified Timeline Followback Interview using 7-day point prevalence abstinence with study staff and then confirmed via a mailed saliva cotinine test.
Time frame
post-treatment (6 weeks) and at 6-week follow-up (week 12).Secondary outcomes
1
ENDS use
Frequency of ENDS use as determined by Timeline Followback Interview with study staff will be measured as a secondary outcome.
Time frame
post-treatment (6 weeks) and at 6-week follow-up (week 12).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov