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NCT Number: NCT07459621

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

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.

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Key information

Conditions

Smoking Behaviors Behavior Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location status: Recruiting

Location contact

Anna C Edelmann, MScN

CONTACT

[email protected]

866-459-2816

Jennifer B McClure, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control 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

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.

Primary outcomes

  1. Evidence-based treatment request

    Time frame: 6-months post-randomization

    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.

  2. 7-day Point Prevalence Abstinence (PPA) [Self-report]

    Time frame: 6-months post-randomization

    Self-report of no smoking, even a puff, in the past 7 days.

Secondary outcomes

  1. 7-day Point Prevalence Abstinence (PPA) [Self-report]

    Time frame: 3-months post-randomization

    Self-report of no smoking, even a puff, in the past 7 days. (Co-primary outcome assessed at earlier time point)

  2. 30-day Point Prevalence Abstinence (PPA) [Self-report]

    Time frame: 3- and 6-months post-randomization

    Self-report of no smoking, even a puff, in the past 30 days.

  3. 7-day Point Prevalence Abstinence (PPA) [Confirmed]

    Time frame: 6-months post-randomization

    Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days.

  4. Evidence-based treatment request

    Time frame: 3-months post-randomization

    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).

  5. Use of any cessation treatment

    Time frame: 3- and 6-months post-randomization

    Self-reported use of any evidence-based smoking cessation treatment (FDA-approved medication or behavioral interventions) since enrollment, whether provided by study or not.

  6. Successful 24-hour quit attempt

    Time frame: By 3-months and 6-months post-randomization

    Self-reported presence of an intentional quit attempt lasting at least 24 hrs (Y/N) since randomization.

  7. Any quit attempt

    Time frame: By 3-months and 6-months post-randomization

    Self-reported presence of any intentional quit attempt, regardless of duration (Y/N) since study enrollment.

  8. Change in cigarettes per day

    Time frame: Baseline to each of 3-months and 6-months post-randomization

    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).

  9. Tobacco and nicotine abstinence

    Time frame: 3- and 6-months post-randomization

    Self-report of abstinence from all non-therapeutic nicotine and tobacco products.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna C Edelmann, MScN

CONTACT

[email protected]

866-459-2816

Jennifer B McClure, PhD

CONTACT

[email protected]

503-335-2400

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • National Cancer Institute (NCI)
  • University of California, Davis

Registry information

Official study title

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

Acronym: GEMS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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