Development of a mHealth Intervention for Ambivalent Smokers | NCT04560868

ID	Type	Description	Link
R21CA234003	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH

Development of a mHealth Intervention for Ambivalent Smokers | NCT04560868 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator		Device: Control mHealth program Drug: Nicotine patch
Experimental	Experimental		Device: Experimental mHealth program Drug: Nicotine patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control mHealth program	Device	The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Program Engagement	Number of unique app user-sessions	Assessed at 3-month follow-up
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.	Assessed at 3-month follow-up
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.	Assessed at 3-month follow-up

Secondary Outcomes

Measure	Description	Time Frame
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".	Assessed at 1 month
Satisfaction With Assigned App

Contacts/Locations Module

Name	Affiliation	Role
Jennifer McClure, PhD	Kaiser Permanente	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente Washington Health Research Institute		Seattle	Washington	98101	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37379059	Derived	McClure JB, Heffner JL, Krakauer C, Mun S, Klasnja P, Catz SL. Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study. JMIR Mhealth Uhealth. 2023 Jun 28;11:e46155. doi: 10.2196/46155.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00029 subjects FG00128 subjects
Completed 1-month Self-report Survey		FG00028 subjects FG00121 subjects
Completed 3-month Self-report Survey		FG00026 subjects FG00121 subjects
Completed App Utilization Period		FG00029 subjects FG00128 subjects
COMPLETED		FG00029 subjects FG00128 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Program Engagement

Number of unique app user-sessions

All individuals who installed the app (n = 57).

Posted

Mean

Standard Deviation

User sessions

Assessed at 3-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Director, Investigative Science	Kaiser Permanente Washington Health Research Institute	206-287-2737		jennifer.b.mcclure@kp.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 22, 2022	Sep 26, 2022	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D014029	Tobacco Use Disorder
D016540	Smoking Cessation
D012907	Smoking

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D015438	Health Behavior

ID	Term
D061485	Tobacco Use Cessation Devices

ID	Term
D013812	Therapeutics

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG0020
Not Hispanic or Latino	BG00029 BG00128 BG00257
Unknown or Not Reported	BG0000 BG0010 BG0020

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0001 BG0011 BG0022
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0002 BG0012 BG0024
White	BG00024 BG00123 BG00247
More than one race	BG0002 BG0011 BG0023
Unknown or Not Reported	BG0000 BG0011 BG0021

7-day point prevalence abstinence

Positive if the participant abstained from smoking (even a puff) in the past 7 days.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0000 BG0010 BG0020

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Regression, Linear		<0.01		Mean Difference (Final Values)	12.73			2-Sided	95	6.41	19.05			mean difference=experimental-control		Equivalence	The point null hypothesis was a difference in expected number of log ins of exactly 0.

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.

All individuals who installed the app (n = 57).

Posted

Count of Participants

Participants

Assessed at 3-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG00011 OG00111

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Regression, Poisson		0.98		Risk Ratio (RR)	1.01			2-Sided	95	0.55	1.85			relative risk=experimental/control		Equivalence	The null hypothesis was a point null of relative risk equal to exactly 1.

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.

All individuals who installed the app (n = 57).

Posted

Count of Participants

Participants

Assessed at 3-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0014

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Regression, Linear		0.35		Risk Difference (RD)	0.08			2-Sided	95	-0.08	0.24			Risk difference = experimental - control.		Equivalence	The null hypothesis was a point null of exactly 0 risk difference between arms.

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".

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.

Posted

Mean

Standard Deviation

score on a scale

Assessed at 1 month

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00025 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0003.6± 1.2 OG0013.8± 1.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.40		Mean Difference (Final Values)	0.26			2-Sided	95	-0.35	0.87			mean difference=experimental-control		Equivalence	The null hypothesis was a point null of exactly 0 difference in expected score between arms.

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".

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.

Posted

Mean

Standard Deviation

score on a scale

Assessed at 3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00023 OG00120

Title

Denominators

Categories

Title	Measurements
	OG0004.0± 1.1 OG0014.0± 1.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.90		Mean Difference (Final Values)	-0.04			2-Sided	95	-0.68	0.60			mean difference=experimental-control		Equivalence	The null hypothesis was a point null of exactly 0 difference in expected score between arms.

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".

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.

Posted

Mean

Standard Deviation

average scores on a scale

Assessed at 1 month.

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0007 OG0015

Title

Denominators

Categories

Title	Measurements
	OG0003.2± 1.2 OG0013.8± 0.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.39		Mean Difference (Final Values)	0.4			2-Sided	95	-0.5	1.4			mean difference=experimental-control		Equivalence	The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.

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".

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.

Posted

Mean

Standard Deviation

average scores on a scale

Assessed at 3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0005 OG0015

Title

Denominators

Categories

Title	Measurements
	OG0003.1± 0.6 OG0013.6± 0.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.11		Mean Difference (Final Values)	0.6			2-Sided	95	-0.1	1.3			mean difference=experimental-control		Equivalence	The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.

Secondary

Program Engagement - Earned Badges

Number of accumulated badge rewards earned from using the assigned app.

All individuals who installed the app (n = 57).

Posted

Mean

Standard Deviation

badges

Assessed at 1-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0005.7± 3.7 OG0018.6± 5.8

Secondary

Program Engagement - Earned Badges

Number of accumulated badge rewards earned from using the assigned app.

Includes all individuals who installed the app. Everyone used the app at least once.

Posted

Mean

Standard Deviation

Badges

Assessed at 3-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0006.1± 3.5 OG00110.1± 6.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		<0.01		Mean Difference (Final Values)	4.2			2-Sided	95	1.72	6.65			mean difference=experimental-control		Equivalence	The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.

Secondary

Self-efficacy to Quit Smoking

Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".

Respondents to the assessed question, which was only asked to those still smoking at follow-up and had installed the app.

Posted

Mean

Standard Deviation

score on a scale

Assessed at 1 month

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00027 OG00120

Title

Denominators

Categories

Title	Measurements
	OG0007.5± 2.3 OG0017.4± 2.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.96		Mean Difference (Final Values)	0.08			2-Sided	95	-1.02	1.18			mean difference=experimental-control		Equivalence	The null hypothesis was a point null of exactly 0 difference in expected score between arms.

Secondary

Self-efficacy to Quit Smoking

Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".

Respondents to the assessed question, which was only asked among individuals who were still smoking at follow-up and had installed the app.

Posted

Mean

Standard Deviation

score on a scale

Assessed at 3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00023 OG00117

Title

Denominators

Categories

Title	Measurements
	OG0007.9± 2.1 OG0016.8± 2.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.31		Mean Difference (Final Values)	-0.44			2-Sided	95	-1.55	0.66			mean difference=experimental-control		Equivalence	The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.

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".

Respondents to a question only asked among participants who installed the app and reported they had not smoked in the past 7 days.

Posted

Mean

Standard Deviation

score on a scale

Assessed at 1 month

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0000 OG0011

Title

Denominators

Categories

Title	Measurements
	OG0016± NAThe Overall Number of Participants Analyzed is 1, so the Standard Deviation was not calculated.

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".

Respondents to question asked among individuals who installed the app and reported not smoking in the past 7 days at 3 month follow-up.

Posted

Mean

Standard Deviation

score on a scale

Assessed at 3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0001 OG0012

Title

Denominators

Categories

Title	Measurements
	OG00010± NAThe Overall Number of Participants Analyzed is 1, so the Standard Deviation was not calculated. OG0019± 1.4

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.

All individuals who installed the app (n = 57).

Posted

Count of Participants

Participants

Assessed at 1-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0014

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.

Individuals who installed the app (n = 57). Note that free NRT is earned when 6 utilization badges have been earned.

Posted

Count of Participants

Participants

Assessed at 3-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0018

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Poisson		0.06		Risk Ratio (RR)	3.9			2-Sided	95	0.9	16.9			RR=experimental/control		Equivalence	The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.

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.

Individuals who installed the app (n = 57).

Posted

Count of Participants

Participants

Assessed at 1 month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0016

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Poisson		0.99		Risk Ratio (RR)	1.01			2-Sided	95	0.38	2.65			risk ratio=experimental/control		Equivalence	The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.

Secondary

Change in Cigarettes/Day

Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.

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.

Posted

Mean

Standard Deviation

Cigarettes/day

Assessed at baseline and 1 month

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00027 OG00121

Title

Denominators

Categories

Baseline 30-day average cigarettes/day

Title	Measurements
	OG00017.9± 6.8 OG00117.6± 8.2

Change from baseline in number of cigarettes/day at 1 month (using one-month 7-day average)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.30		Mean Difference (Net)	1.39			2-Sided	95	-1.21	3.99			treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.		Equivalence	The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.

Secondary

Change in Cigarettes/Day

Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.

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.

Posted

Mean

Standard Deviation

Cigarettes/day

Assessed at baseline and 3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00025 OG00121

Title

Denominators

Categories

Baseline 30-day average cigarettes/day

Title	Measurements
	OG00017.6± 6.9 OG00117.9± 8.0

Change in daily average cigarettes/day between baseline and three-month (using 7-day average)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.47		Mean Difference (Net)	1.5			2-Sided	95	-2.51	5.5			treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.		Equivalence	The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.

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.

Individuals who installed the app (n = 57).

Posted

Count of Participants

Participants

Assessed at 1-month follow-up

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00029 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.30		Risk Difference (RD)	0.04			2-Sided	95	-0.03	0.11			risk difference=experimental-control		Equivalence	The null hypothesis was risk difference of exactly 0.