Smoking Behaviors
Conditions
Keywords
Smoking, mHealth, motivation, ambivalent smokers
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. We 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. We 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
BEHAVIORALControl 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.
BEHAVIORALExperimental 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.
Sponsors
Kaiser Permanente
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence-based treatment request | 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. |
| 7-day Point Prevalence Abstinence (PPA) [Self-report] | 6-months post-randomization | Self-report of no smoking, even a puff, in the past 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence-based treatment request | 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). |
| 7-day Point Prevalence Abstinence (PPA) [Self-report] | 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) |
| Use of any cessation treatment | 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. |
| Successful 24-hour quit attempt | 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. |
| Any quit attempt | By 3-months and 6-months post-randomization | Self-reported presence of any intentional quit attempt, regardless of duration (Y/N) since study enrollment. |
| Change in cigarettes per day | 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). |
| 30-day Point Prevalence Abstinence (PPA) [Self-report] | 3- and 6-months post-randomization | Self-report of no smoking, even a puff, in the past 30 days. |
| Tobacco and nicotine abstinence | 3- and 6-months post-randomization | Self-report of abstinence from all non-therapeutic nicotine and tobacco products. |
| 7-day Point Prevalence Abstinence (PPA) [Confirmed] | 6-months post-randomization | Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days. |
Countries
United States
Contacts
CONTACTJennifer B McClure, PhD
CONTACTAnna C Edelmann, MScN
Outcome results
None listed