Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking
GEMS
2 other identifiers
interventional
800
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
March 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 30, 2026
April 1, 2026
2.7 years
March 5, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6-months post-randomization
7-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 7 days.
6-months post-randomization
Secondary Outcomes (9)
7-day Point Prevalence Abstinence (PPA) [Self-report]
3-months post-randomization
30-day Point Prevalence Abstinence (PPA) [Self-report]
3- and 6-months post-randomization
7-day Point Prevalence Abstinence (PPA) [Confirmed]
6-months post-randomization
Evidence-based treatment request
3-months post-randomization
Use of any cessation treatment
3- and 6-months post-randomization
- +4 more secondary outcomes
Study Arms (2)
Control Intervention
ACTIVE COMPARATORControl participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions.
Experimental
EXPERIMENTALExperimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Daviscollaborator
- Kaiser Permanentelead
- National Cancer Institute (NCI)collaborator
- Fred Hutchinson Cancer Centercollaborator
Study Sites (1)
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 10, 2026
Study Start
March 29, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Deidentified data and accompanying data dictionaries will be stored for future sharing as anonymized data sets in a data repository per NIH data sharing requirements.