Recruiting

Smoking Cessation

Sponsor:

Kaiser Permanente

Code:

NCT07459621

Conditions

Smoking Behaviors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Control Intervention

Experimental Intervention

Study Details

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.

Conditions

Smoking Behaviors

Study ID

NCT07459621

Start date

Apr 7, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Intervention

Control participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions.

experimental: Experimental

Experimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions.

Interventions

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 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.

Primary outcome measure

  • Evidence-based treatment request [ Time Frame: 6-months post-randomization ]
  • 7-day Point Prevalence Abstinence (PPA) [Self-report] [ Time Frame: 6-months post-randomization ]

Central Contacts and Locations

Central contacts

Locations

Kaiser Permanente Center for Health Research

Recruiting

Portland, Oregon, United States, 97227

Contacts

Principal Investigator:

Jennifer B McClure, PhD

More Information

Sponsor

Kaiser Permanente

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Smoking
  • mHealth
  • motivation
  • ambivalent smokers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-07-10.