Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers

• Sponsor: University of Massachusetts, Worcester (Other)
• Overall Status: Completed
• CT.gov ID: NCT02973425
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 433
• Locations: 4
• Arms: 2
• Actual Duration (Months): 44.7
• Patients Per Site: 108.3
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase; Behavioral: NRT and mHealth assessment tool without feedback	N/A

Detailed Description

The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are

• AIM 1: Refine the Take a Break mHealth tool and implementation program.

• AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.

• AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 433 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
• Actual Study Start Date: Nov 7, 2016
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NRT and mHealth assessment tool without feedback For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback.	Behavioral: NRT and mHealth assessment tool without feedback; NRT and mHealth assessment tool without feedback
Experimental: Take a Break as an augmentation to NRT in Motivation The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite.	Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase; NRT sampling experience & Suite of mHealth motivational tools and mini-games.

Outcome Measures

Primary Outcome Measures

1. Time to First Quit Attempt [6 months]

   Time to first quit attempt is measured by participant self-report of number of days from baseline to first quit attempt within a 6 month period. At the 6-month follow-up visit, the dates of all quit attempts were assessed using the Timeline Follow-Back Method and used to calculate time to first quit attempt.

Secondary Outcome Measures

1. Change in Self-Efficacy at the End of the 6 Months [6 months]

   Self Efficacy is measured by the Self-Efficacy Questionnaire (SEQ-12).The SEQ-12 is a 12-item instrument (two six-item subscales) that measures the confidence in ability to refrain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers). The scale varies from 1-5 [Not at all (1) Not very(2) Moderately(3) Very (4) Extremely (5)] A higher score indicates a higher level of confidence to refrain from smoking in certain social or emotional situations and a lower score indicates a lower level of confidence to refrain from smoking.

2. Point Prevalent Cessation as Measured by Carbon Monoxide Levels [6 months]

   Point prevalent cessation here is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.

3. Mean Number of Days Abstinent During the First 3 Weeks [3 Weeks]

   Measure the mean number of days abstinent as self-reported by participant via the mHealth assessment.

4. Number of Participants Abstinent During the First 3 Weeks [3 Weeks]

   Number of participants abstinent within the 3 week period as self-reported by participant via the mHealth assessment. .

Other Outcome Measures

1. Number of Participants Completing Daily Challenge Quiz [3 weeks]

   Participants were asked to complete daily challenge quizzes during the first 3 weeks of participation. The challenge quizzes contained daily self-assessment text messages and motivational replies (intervention only)

2. Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal. [1 week]

   Participants in the Intervention group were asked to participate in a goal-setting call to establish a smoking abstinence goal (typically one to two days of abstinence from cigarettes). The outcome measures the number of participants who completed to goal-setting call.

3. Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings. [3 week]

   TAB participants were encouraged to use mHealth apps that provide relaxation or distraction to help manage smoking cravings. The study team measured the number of participants used mHealth apps to manage nicotine cravings in a 3 week period.

4. Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist) [2 week]

   At one week TAB participants were asked to whether they would like to set an abstinence goal for the following 2-week challenge. The outcome measures the number of participants in the TAB group who set a brief abstinence goal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.

Exclusion Criteria:

• Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.

Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reliant Medical Group	Worcester	Massachusetts	United States	01605
2	VA Central Western Massachusetts Healthcare System	Worcester	Massachusetts	United States	01605
3	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
4	Northwell Health	Great Neck	New York	United States	11030

Sponsors and Collaborators

• University of Massachusetts, Worcester
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Rajani S Sadasivam, PhD, UMMS

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 11, 2021

More Information

Publications

None provided.

• Responsible Party: Rajani Sadasivam, Principal Investigator, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT02973425
• Other Study ID Numbers: H00007427; R01CA190866-01A1; R25CA172009-01A1
• First Posted: Nov 25, 2016
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rajani Sadasivam, Principal Investigator, University of Massachusetts, Worcester: mHealth, Smoking cessation,

Study Results

Participant Flow

Recruitment Details	Study participants were recruited from UMMHC, Northwell Health, VACWM. Recruitment activities started on November 2016.

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Period Title: Overall Study
STARTED	220	213
COMPLETED	171	160
NOT COMPLETED	49	53

Baseline Characteristics

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation	Total
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.	Total of all reporting groups
Overall Participants	220	213	433
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	169 76.8%	163 76.5%	332 76.7%
>=65 years	43 19.5%	38 17.8%	81 18.7%
Sex: Female, Male (Count of Participants)
Female	108 49.1%	115 54%	223 51.5%
Male	112 50.9%	98 46%	210 48.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 12.7%	15 7%	43 9.9%
Not Hispanic or Latino	190 86.4%	197 92.5%	387 89.4%
Unknown or Not Reported	2 0.9%	1 0.5%	3 0.7%
Region of Enrollment (participants) [Number]
United States	220 100%	213 100%	433 100%

Outcome Measures

1. Primary Outcome

Title	Time to First Quit Attempt
Description	Time to first quit attempt is measured by participant self-report of number of days from baseline to first quit attempt within a 6 month period. At the 6-month follow-up visit, the dates of all quit attempts were assessed using the Timeline Follow-Back Method and used to calculate time to first quit attempt.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	171	160
Mean (Standard Deviation) [days]	0.89 (1.04)	1.48 (2.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NRT and mHealth Assessment Tool Without Feedback, Take a Break as an Augmentation to NRT in Motivation
	Comments	The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95%; 1.09 to 2.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Self-Efficacy at the End of the 6 Months
Description	Self Efficacy is measured by the Self-Efficacy Questionnaire (SEQ-12).The SEQ-12 is a 12-item instrument (two six-item subscales) that measures the confidence in ability to refrain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers). The scale varies from 1-5 [Not at all (1) Not very(2) Moderately(3) Very (4) Extremely (5)] A higher score indicates a higher level of confidence to refrain from smoking in certain social or emotional situations and a lower score indicates a lower level of confidence to refrain from smoking.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	171	160
Mean (Standard Deviation) [SEQ-12 overall score (mean)]	2.7 (0.9)	2.9 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Take a Break as an Augmentation to NRT in Motivation
	Comments	For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Linear regression
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Point Prevalent Cessation as Measured by Carbon Monoxide Levels
Description	Point prevalent cessation here is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	171	160
Count of Participants [Participants]	17 7.7%	28 13.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NRT and mHealth Assessment Tool Without Feedback, Take a Break as an Augmentation to NRT in Motivation
	Comments
	Type of Statistical Test	Other
	Comments	Six-month OR, 95%CI, and P value were calculated from generalized estimating equation marginal models with a logit link and an exchangeable correlation matrix.
Statistical Test of Hypothesis	p-Value	0.048
	Comments	Analysis models were adjusted by study site, having quit attempts in the past 12 months measured at baseline, cigarettes per day measured at baseline, quit attempts in the past 12 months measured at baseline.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95%; 1.01 to 3.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Mean Number of Days Abstinent During the First 3 Weeks
Description	Measure the mean number of days abstinent as self-reported by participant via the mHealth assessment.
Time Frame	3 Weeks

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is higher than the number of participants who completed the study as all participants were able to self-reported the number of days abstinent at three weeks.

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	209	200
Mean (Standard Deviation) [days]	0.60 (2.38)	1.20 (3.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NRT and mHealth Assessment Tool Without Feedback
	Comments	During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.01
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Participants Abstinent During the First 3 Weeks
Description	Number of participants abstinent within the 3 week period as self-reported by participant via the mHealth assessment. .
Time Frame	3 Weeks

Outcome Measure Data

Analysis Population Description

The population analyzed includes participants who eventually dropped out.

Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	209	200
Count of Participants [Participants]	29 13.2%	49 23%

6. Other Pre-specified Outcome

Title	Number of Participants Completing Daily Challenge Quiz
Description	Participants were asked to complete daily challenge quizzes during the first 3 weeks of participation. The challenge quizzes contained daily self-assessment text messages and motivational replies (intervention only)
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is higher than the number of participants who completed the study as all participants were able to complete daily challenge quizzes at baseline and at three weeks.

Arm/Group Title	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	213
Count of Participants [Participants]	112 50.9%

7. Other Pre-specified Outcome

Title	Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal.
Description	Participants in the Intervention group were asked to participate in a goal-setting call to establish a smoking abstinence goal (typically one to two days of abstinence from cigarettes). The outcome measures the number of participants who completed to goal-setting call.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is higher than the number of participants who completed the study as more participants were able to complete goal setting at baseline.

Arm/Group Title	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	213
Count of Participants [Participants]	199 90.5%

8. Other Pre-specified Outcome

Title	Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings.
Description	TAB participants were encouraged to use mHealth apps that provide relaxation or distraction to help manage smoking cravings. The study team measured the number of participants used mHealth apps to manage nicotine cravings in a 3 week period.
Time Frame	3 week

Outcome Measure Data

Analysis Population Description

The number of participants analyzed varies from number completed to reflect the number of participants still engaged at 3 weeks.

Arm/Group Title	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	213
Count of Participants [Participants]	159 72.3%

9. Other Pre-specified Outcome

Title	Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist)
Description	At one week TAB participants were asked to whether they would like to set an abstinence goal for the following 2-week challenge. The outcome measures the number of participants in the TAB group who set a brief abstinence goal
Time Frame	2 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
Measure Participants	213
Count of Participants [Participants]	145 65.9%

Adverse Events

Time Frame	Adverse events were monitored/assessed for each participant through study completion up to six months.
Adverse Event Reporting Description	No Adverse Event
Arm/Group Title	NRT and mHealth Assessment Tool Without Feedback		Take a Break as an Augmentation to NRT in Motivation
Arm/Group Description	For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control. Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback		The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games.
All Cause Mortality
	NRT and mHealth Assessment Tool Without Feedback		Take a Break as an Augmentation to NRT in Motivation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		0/213 (0%)
Serious Adverse Events
	NRT and mHealth Assessment Tool Without Feedback		Take a Break as an Augmentation to NRT in Motivation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		0/213 (0%)
Other (Not Including Serious) Adverse Events
	NRT and mHealth Assessment Tool Without Feedback		Take a Break as an Augmentation to NRT in Motivation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		0/213 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.