Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking (GEMS)

Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Behaviors
• Intervention / Treatment: Behavioral: Control Intervention; Behavioral: Experimental Intervention

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer B McClure, PhD; Phone Number: 503-335-2400; Email: jennifer.b.mcclure@kp.org
• Study Contact Backup: Name: Anna C Edelmann, MScN; Phone Number: 866-459-2816; Email: anna.c.edelmann@kpchr.org

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Recruiting
      • Kaiser Permanente Center for Health Research
      • Contact: Anna C Edelmann, MScN; Phone Number: 866-459-2816; Email: anna.c.edelmann@kpchr.org
      • Principal Investigator: Jennifer B McClure, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Intervention; Control participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions.	Behavioral: Control Intervention; 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: Experimental; Experimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions.	Behavioral: Experimental Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3-months post-randomization
30-day Point Prevalence Abstinence (PPA) [Self-report]	Self-report of no smoking, even a puff, in the past 30 days.	3- and 6-months post-randomization
7-day Point Prevalence Abstinence (PPA) [Confirmed]	Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days.	6-months post-randomization
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).	3-months post-randomization
Use of any cessation treatment	Self-reported use of any evidence-based smoking cessation treatment (FDA-approved medication or behavioral interventions) since enrollment, whether provided by study or not.	3- and 6-months post-randomization
Successful 24-hour quit attempt	Self-reported presence of an intentional quit attempt lasting at least 24 hrs (Y/N) since randomization.	By 3-months and 6-months post-randomization
Any quit attempt	Self-reported presence of any intentional quit attempt, regardless of duration (Y/N) since study enrollment.	By 3-months and 6-months post-randomization
Change in cigarettes per day	Change from baseline in number of cigarettes smoked per day at follow-up, calculated both as a continuous measure and as a dichotomous measure (Y/N >=50% reduction from baseline).	Baseline to each of 3-months and 6-months post-randomization
Tobacco and nicotine abstinence	Self-report of abstinence from all non-therapeutic nicotine and tobacco products.	3- and 6-months post-randomization

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI); University of California, Davis; Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Smoking; mHealth; motivation; ambivalent smokers
• Additional Relevant MeSH Terms: Behavior; Smoking
• Other Study ID Numbers: 2171564; R01CA293229 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No