What this study is
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.
What's being tested
- Control Intervention
Intervention · BEHAVIORAL
GEMS 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
Intervention · BEHAVIORAL
GEMS 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.
Study details
- Official title
- Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial
- Sponsor
- Kaiser Permanente
- Conditions
- Smoking Behaviors
- Enrolling
- 800 people
- Starts
- 2026-04-07
- Est. completion
- 2028-12-31
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- State willingness to install and use their assigned app
- Willingness to receive study communications
- Smoke at least half a pack a day
- Meet geolocation requirements
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openKaiser Permanente Center for Health Research
Portland, Oregon, United States
- Anna C Edelmann, MScN · Contact866-459-2816anna.c.edelmann@kpchr.org
- Jennifer B McClure, PhD · Principal investigator
Recruiting
Study team
Sponsor
Kaiser Permanente
Study ID 2171564
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.