Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking
ConditionSmoking Behaviors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes additional content designed for people who aren't ready to quit smoking.
The investigators hypothesize that people who receive the experimental intervention will be more likely to request additional stop-smoking resources offered through the intervention and report smoking abstinence after 6 months.
The investigators also hypothesize people assigned to the experimental app will have better app engagement and be more likely to report positive changes in their smoking behavior and use of other evidence-based stop smoking treatments that are publicly available.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age and older
Current cigarette smoker who is ambivalent about smoking
Not actively using any treatment to quit smoking
Own and regularly use a smartphone
Disqualifiers
A lifetime history of dementia or psychosis
Visual impairments that prevent viewing phone content and they lack adaptive devices
Report medical contra-indications for over-the-counter NRT use
Due to the potential for bias introduced by fraudulent participants, other exclusions will be applied to deter fraudulent enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
Control Intervention
BehavioralGEMS mHealth app including standard, best-practice information and advice to support quitting smoking, in-app motivational support, and access to publicly-available, evidence-based stop smoking resources and treatment. App can be used ad-lib during the study duration.
Experimental Intervention
BehavioralGEMS mHealth app including same standard care, best-practice information and advice for quitting smoking and in-app motivational support as in the control arm, plus additional content designed to help users clarify their values, build motivation for change, and learn skills necessary to quit smoking. App can be used ad-lib during the study duration.
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Control InterventionActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evidence-based treatment request
Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app.
Time frame
6-months post-randomization2
7-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 7 days.
Time frame
6-months post-randomizationSecondary outcomes
1
7-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 7 days. (Co-primary outcome assessed at earlier time point)
Time frame
3-months post-randomization2
30-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 30 days.
Time frame
3- and 6-months post-randomization3
7-day Point Prevalence Abstinence (PPA) [Confirmed]
Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days.
Time frame
6-months post-randomization4
Evidence-based treatment request
Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app. (Co-primary outcome assessed at earlier time point).
Time frame
3-months post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Fred Hutchinson Cancer Center
Collaborator
University of California, Davis
Collaborator
Source ClinicalTrials.gov