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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Kaiser Permanente
Study ID
NCT07459621
Status
Recruiting
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Conditions

  • Smoking Behaviors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 29, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Evidence-based treatment request [ Time Frame: 6-months post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Center for Health ResearchPortlandOregon97227
Anna C Edelmann, MScN
[email protected]
866-459-2816
Jennifer B McClure, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Kaiser Permanente Center for Health Research· Portland, OR

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