Behavior, Smoking, Motivation, Smoking Cessation, Tobacco Use Disorder
Conditions
Keywords
mHealth, smoking, smoking cessation, motivation
Brief summary
The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.
Interventions
DEVICEControl mHealth program
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
DEVICEExperimental mHealth program
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
DRUGNicotine patch
Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
Sponsors
National Cancer Institute (NCI)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older; * Can speak/read English; * Current smoker; * Own and regularly use an eligible smartphone; * No vision impairments; * Willing to install and use the study program; * Willing to use birth control if elect to use nicotine replacement during the study (females); * Meet definition for ambivalence * Not actively using treatment
Exclusion criteria
* Smoke less than 10 cigarettes per day * Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia; * Have medical contraindications for nicotine replacement therapy; * Another household member is enrolled in the study * Unable to verify contact information * Fail to install app
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Engagement | Assessed at 3-month follow-up | Number of unique app user-sessions |
| Quit Attempt Lasting at Least 24 Hours | Assessed at 3-month follow-up | At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt. |
| Not Smoking (Even a Puff) in the Last 7 Days | Assessed at 3-month follow-up | 7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy to Quit Smoking | Assessed at 1 month | Self-reported confidence in quitting smoking on Likert scale from 1=not at all to 10=extremely. |
| Self-efficacy to Stay Quit | Assessed at 1 month | Self-reported confidence in ability to stay quit on a Likert scale from 1=not at all to 10=extremely. |
| Earned and Requested Free Nicotine Replacement Therapy | Assessed at 1-month follow-up | Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges. |
| Satisfaction With Assigned App | Assessed at 1 month | Satisfaction with the overall content and advice of the assigned app, rated on a Likert scale from 1=not at all satisfied to 5=extremely satisfied. |
| Change in Cigarettes/Day | Assessed at baseline and 1 month | Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline. |
| Refrain From Smoking (Even a Puff) in the Last 7 Days | Assessed at 1-month follow-up | 7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking. |
| Quit Attempt Lasting at Least 24 Hours | Assessed at 1 month follow-up | At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt. |
| Helpfulness of Assigned App | Assessed at 1 month. | Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1=not at all helpful to 5=extremely helpful. |
| Program Engagement - Earned Badges | Assessed at 1-month follow-up | Number of accumulated badge rewards earned from using the assigned app. |
Countries
United States
Participant flow
Recruitment details
Study enrollment began 12/16/2020 and study activities completed 9/27/21. Participants were recruited through two sources: (1) social media ads inviting individuals to email contact study staff to learn more and be screened for eligibility and (2) outreach to people our research waitlist.
Participants by arm
| Arm | Count |
|---|---|
| Control Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program. | 29 |
| Experimental Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program. | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | Total | Experimental | Control |
|---|---|---|---|
| 7-day point prevalence abstinence | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 27 Participants | 29 Participants |
| Age, Continuous | 47.5 years STANDARD_DEVIATION 10.3 | 47.9 years STANDARD_DEVIATION 11.5 | 47.1 years STANDARD_DEVIATION 9.1 |
| At least one quit attempt lasting a day or longer in the past 12 months | 14 Participants | 7 Participants | 7 Participants |
| Cigarettes per day | 18.2 cigarettes/day STANDARD_DEVIATION 7.6 | 18.5 cigarettes/day STANDARD_DEVIATION 8.7 | 17.8 cigarettes/day STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 28 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 23 Participants | 24 Participants |
| Sex: Female, Male Female | 41 Participants | 19 Participants | 22 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Not Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Time frame: Assessed at 3-month follow-up
Population: All individuals who installed the app (n = 57).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Not Smoking (Even a Puff) in the Last 7 Days | 2 Participants |
| Experimental | Not Smoking (Even a Puff) in the Last 7 Days | 4 Participants |
Comparison: Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.p-value: 0.3595% CI: [-0.08, 0.24]Regression, Linear
Primary
Program Engagement
Number of unique app user-sessions
Time frame: Assessed at 3-month follow-up
Population: All individuals who installed the app (n = 57).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Program Engagement | 7.3 User sessions | Standard Deviation 6.6 |
| Experimental | Program Engagement | 19.9 User sessions | Standard Deviation 16.2 |
Comparison: Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.p-value: <0.0195% CI: [6.41, 19.05]Regression, Linear
Primary
Quit Attempt Lasting at Least 24 Hours
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Time frame: Assessed at 3-month follow-up
Population: All individuals who installed the app (n = 57).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Quit Attempt Lasting at Least 24 Hours | 11 Participants |
| Experimental | Quit Attempt Lasting at Least 24 Hours | 11 Participants |
Comparison: Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.p-value: 0.9895% CI: [0.55, 1.85]Regression, Poisson
Secondary
Change in Cigarettes/Day
Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.
Time frame: Assessed at baseline and 3 months
Population: Individuals who installed the app, returned the 3-month survey, and either responded to this item or reported not smoking in the past 7 days. If they reported not smoking for the past 7 days, number of cigarettes were day were coded as 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Cigarettes/Day | Baseline 30-day average cigarettes/day | 17.6 Cigarettes/day | Standard Deviation 6.9 |
| Control | Change in Cigarettes/Day | Change in daily average cigarettes/day between baseline and three-month (using 7-day average) | -6.7 Cigarettes/day | Standard Deviation 7.9 |
| Experimental | Change in Cigarettes/Day | Baseline 30-day average cigarettes/day | 17.9 Cigarettes/day | Standard Deviation 8 |
| Experimental | Change in Cigarettes/Day | Change in daily average cigarettes/day between baseline and three-month (using 7-day average) | -5.2 Cigarettes/day | Standard Deviation 7 |
p-value: 0.4795% CI: [-2.51, 5.5]Regression, Linear
Secondary
Change in Cigarettes/Day
Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.
Time frame: Assessed at baseline and 1 month
Population: Individuals who installed the app, returned the 1-month survey, and either responded to this item or reported not smoking in the past 7 days. If they reported not smoking for the past 7 days, number of cigarettes were day were coded as 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Cigarettes/Day | Baseline 30-day average cigarettes/day | 17.9 Cigarettes/day | Standard Deviation 6.8 |
| Control | Change in Cigarettes/Day | Change from baseline in number of cigarettes/day at 1 month (using one-month 7-day average) | -5.1 Cigarettes/day | Standard Deviation 5.2 |
| Experimental | Change in Cigarettes/Day | Baseline 30-day average cigarettes/day | 17.6 Cigarettes/day | Standard Deviation 8.2 |
| Experimental | Change in Cigarettes/Day | Change from baseline in number of cigarettes/day at 1 month (using one-month 7-day average) | -3.6 Cigarettes/day | Standard Deviation 4.6 |
p-value: 0.395% CI: [-1.21, 3.99]Regression, Linear
Secondary
Earned and Requested Free Nicotine Replacement Therapy
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Time frame: Assessed at 1-month follow-up
Population: All individuals who installed the app (n = 57).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Earned and Requested Free Nicotine Replacement Therapy | 2 Participants |
| Experimental | Earned and Requested Free Nicotine Replacement Therapy | 4 Participants |
Secondary
Earned and Requested Free Nicotine Replacement Therapy
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Time frame: Assessed at 3-month follow-up
Population: Individuals who installed the app (n = 57). Note that free NRT is earned when 6 utilization badges have been earned.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Earned and Requested Free Nicotine Replacement Therapy | 2 Participants |
| Experimental | Earned and Requested Free Nicotine Replacement Therapy | 8 Participants |
p-value: 0.0695% CI: [0.9, 16.9]Regression, Poisson
Secondary
Helpfulness of Assigned App
Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1=not at all helpful to 5=extremely helpful.
Time frame: Assessed at 1 month.
Population: Participants who installed the app, self-reported use of all rated features, rated each feature on follow-up survey, and were confirmed via automated data to have used the app features.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Helpfulness of Assigned App | 3.2 average scores on a scale | Standard Deviation 1.2 |
| Experimental | Helpfulness of Assigned App | 3.8 average scores on a scale | Standard Deviation 0.8 |
p-value: 0.3995% CI: [-0.5, 1.4]Regression, Linear
Secondary
Helpfulness of Assigned App
Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1=not at all helpful to 5=extremely helpful.
Time frame: Assessed at 3 months
Population: Individuals who installed the app, responded to questions about helpfulness of each rated feature, self-reported use of each app feature, and based on automated data had sufficient use of the app features to rate their helpfulness at follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Helpfulness of Assigned App | 3.1 average scores on a scale | Standard Deviation 0.6 |
| Experimental | Helpfulness of Assigned App | 3.6 average scores on a scale | Standard Deviation 0.7 |
p-value: 0.1195% CI: [-0.1, 1.3]Regression, Linear
Secondary
Program Engagement - Earned Badges
Number of accumulated badge rewards earned from using the assigned app.
Time frame: Assessed at 3-month follow-up
Population: Includes all individuals who installed the app. Everyone used the app at least once.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Program Engagement - Earned Badges | 6.1 Badges | Standard Deviation 3.5 |
| Experimental | Program Engagement - Earned Badges | 10.1 Badges | Standard Deviation 6 |
p-value: <0.0195% CI: [1.72, 6.65]Regression, Linear
Secondary
Program Engagement - Earned Badges
Number of accumulated badge rewards earned from using the assigned app.
Time frame: Assessed at 1-month follow-up
Population: All individuals who installed the app (n = 57).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Program Engagement - Earned Badges | 5.7 badges | Standard Deviation 3.7 |
| Experimental | Program Engagement - Earned Badges | 8.6 badges | Standard Deviation 5.8 |
Secondary
Quit Attempt Lasting at Least 24 Hours
At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.
Time frame: Assessed at 1 month follow-up
Population: Individuals who installed the app (n = 57).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Quit Attempt Lasting at Least 24 Hours | 6 Participants |
| Experimental | Quit Attempt Lasting at Least 24 Hours | 6 Participants |
p-value: 0.9995% CI: [0.38, 2.65]Regression, Poisson
Secondary
Refrain From Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.
Time frame: Assessed at 1-month follow-up
Population: Individuals who installed the app (n = 57).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Refrain From Smoking (Even a Puff) in the Last 7 Days | 0 Participants |
| Experimental | Refrain From Smoking (Even a Puff) in the Last 7 Days | 1 Participants |
p-value: 0.395% CI: [-0.03, 0.11]Regression, Linear
Secondary
Satisfaction With Assigned App
Satisfaction with the overall content and advice of the assigned app on a Likert scale from 1=not at all satisfied to 5=extremely satisfied.
Time frame: Assessed at 3 months
Population: Responses were assessed among participants who earned at least one utilization badge by the three-month survey. This was done to ensure participants had sufficient interaction with the app to rate their satisfaction with it.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Satisfaction With Assigned App | 4.0 score on a scale | Standard Deviation 1.1 |
| Experimental | Satisfaction With Assigned App | 4.0 score on a scale | Standard Deviation 1.1 |
p-value: 0.995% CI: [-0.68, 0.6]Regression, Linear
Secondary
Satisfaction With Assigned App
Satisfaction with the overall content and advice of the assigned app, rated on a Likert scale from 1=not at all satisfied to 5=extremely satisfied.
Time frame: Assessed at 1 month
Population: Responses were assessed among participants who earned at least one utilization badge by the one-month survey. This ensured participants had sufficient interaction with the app to rate their satisfaction with it.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Satisfaction With Assigned App | 3.6 score on a scale | Standard Deviation 1.2 |
| Experimental | Satisfaction With Assigned App | 3.8 score on a scale | Standard Deviation 1 |
p-value: 0.495% CI: [-0.35, 0.87]Regression, Linear
Secondary
Self-efficacy to Quit Smoking
Self-reported confidence in quitting smoking on Likert scale from 1=not at all to 10=extremely.
Time frame: Assessed at 1 month
Population: Respondents to the assessed question, which was only asked to those still smoking at follow-up and had installed the app.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-efficacy to Quit Smoking | 7.5 score on a scale | Standard Deviation 2.3 |
| Experimental | Self-efficacy to Quit Smoking | 7.4 score on a scale | Standard Deviation 2.4 |
p-value: 0.9695% CI: [-1.02, 1.18]Regression, Linear
Secondary
Self-efficacy to Quit Smoking
Self-reported confidence in quitting smoking on a Likert scale from 1=not at all to 10=extremely.
Time frame: Assessed at 3 months
Population: Respondents to the assessed question, which was only asked among individuals who were still smoking at follow-up and had installed the app.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-efficacy to Quit Smoking | 7.9 score on a scale | Standard Deviation 2.1 |
| Experimental | Self-efficacy to Quit Smoking | 6.8 score on a scale | Standard Deviation 2.7 |
p-value: 0.3195% CI: [-1.55, 0.66]Regression, Linear
Secondary
Self-efficacy to Stay Quit
Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1=not at all to 10=extremely.
Time frame: Assessed at 3 months
Population: Respondents to question asked among individuals who installed the app and reported not smoking in the past 7 days at 3 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-efficacy to Stay Quit | 10 score on a scale | — |
| Experimental | Self-efficacy to Stay Quit | 9 score on a scale | Standard Deviation 1.4 |
Secondary
Self-efficacy to Stay Quit
Self-reported confidence in ability to stay quit on a Likert scale from 1=not at all to 10=extremely.
Time frame: Assessed at 1 month
Population: Respondents to a question only asked among participants who installed the app and reported they had not smoked in the past 7 days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental | Self-efficacy to Stay Quit | 6 score on a scale |