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Recruiting NCT07459621

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

No phase Interventional Smoking Behaviors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control Intervention, Experimental Intervention.
Who it may be relevant to
Registry conditions: Smoking Behaviors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.
  • 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.

Primary outcome measures

  • Evidence-based treatment request [Time frame: 6-months post-randomization]
  • 7-day Point Prevalence Abstinence (PPA) [Self-report] [Time frame: 6-months post-randomization]
Secondary outcome measures (9)
  • 7-day Point Prevalence Abstinence (PPA) [Self-report] [Time frame: 3-months post-randomization]
  • 30-day Point Prevalence Abstinence (PPA) [Self-report] [Time frame: 3- and 6-months post-randomization]
  • 7-day Point Prevalence Abstinence (PPA) [Confirmed] [Time frame: 6-months post-randomization]
  • Evidence-based treatment request [Time frame: 3-months post-randomization]
  • Use of any cessation treatment [Time frame: 3- and 6-months post-randomization]
  • Successful 24-hour quit attempt [Time frame: By 3-months and 6-months post-randomization]
  • Any quit attempt [Time frame: By 3-months and 6-months post-randomization]
  • Change in cigarettes per day [Time frame: Baseline to each of 3-months and 6-months post-randomization]
  • Tobacco and nicotine abstinence [Time frame: 3- and 6-months post-randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kaiser Permanente Center for Health Research — Portland

Identifiers

NCT: NCT07459621 · 2171564 · R01CA293229

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗