Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02873754
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and increase physical activity among low-income persons. The intervention is called Smoking Treatment and Exercise Program for Underserved Populations (STEP UP).

Condition or Disease	Intervention/Treatment	Phase
Smoking	Behavioral: Cognitive Behavioral Counseling; Behavioral: Mobile Contingency Management; Drug: Bupropion; Drug: Transdermal nicotine patch; Drug: Nicotine polacrilex; Drug: Nicotine lozenge	N/A

Detailed Description

This pilot project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and physical activity among low-income persons. The intervention, named Smoking Treatment and Exercise Program for Underserved Populations (STEP UP), combines a smartphone-based contingency-management application (app), which provides monetary reinforcement for smoking abstinence and physical activity, 5 weeks of telephone-based cognitive-behavioral therapy (CBT) to prevent relapse, nicotine replacement pharmacotherapy, and text-messaging to support physical-activity goals. Participants are given a smartphone, a compact carbon-monoxide (CO) monitor, with which recency of smoking can by determined, and a Garmin Vivosmart wristband step-tracker. Twice a day at semi-random intervals, participants are prompted by the app to submit a video of themselves blowing into the CO monitor. Monetary reinforcement is then immediately provided contingent upon a below-threshold CO reading. The app also continuously syncs with the Garmin step-tracker, providing supportive messaging and bonus incentives-namely doubled reinforcement for smoking abstinence among participants who meet personalized daily step goals. The expected outcome of the project is to provide information to evaluate the efficacy of an innovative approach in preparation for a subsequent larger clinical trial that builds upon the capabilities of mHealth technology to reduce the prevalence of smoking among low income smokers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: STEP UP STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.

Behavioral: Cognitive Behavioral Counseling; Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.; Behavioral: Mobile Contingency Management; Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest increased physical activity.; Drug: Bupropion; All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.; Other Names: Zyban ; Drug: Transdermal nicotine patch; Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant; Drug: Nicotine polacrilex; Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed; Other Names: Nicotine gum; nicorette ; Drug: Nicotine lozenge; Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Self-report Prolonged Abstinence From Smoking [6 month follow up]

   Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.

2. Number of Participants Whose Prolonged Abstinence is Bio-verified [6 month follow up]

   Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.

3. Number of Participants Who Self-report Prolonged Abstinence From Smoking [3 month follow up]

   Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.

4. Number of Participants Whose Prolonged Abstinence is Bio-verified [3 month follow up]

   Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.

Secondary Outcome Measures

1. Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking [6 month follow up]

   7-day point prevalence abstinence is defined as no smoking in the prior 7 days.

2. Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking [6 month follow up]

   30-day point prevalence abstinence is defined as no smoking in the prior 30 days.

3. Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking [3 month follow up]

   7-day point prevalence abstinence is defined as no smoking in the prior 7 days.

4. Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking [3 month follow up]

   30-day point prevalence abstinence is defined as no smoking in the prior 30 days.

5. Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale. [baseline and 3 month follow up]

   Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline).

6. Change in the Number of Days in Which Smoked Compared to Pre-quit Use [3 month follow up]

   Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit.

7. Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit [3 month follow up]

   Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date

8. Number of Quit Smoking Attempts [3 month follow up]

   Participants will self-report the number of quit attempts they've had since baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• current household income less than twice the federal poverty guidelines (Finer & Henshaw, 2006; for instance, someone from a family of 4 must have a household income less than $48,500 to be eligible)

• currently smoke >10 cigarettes a day

• smoking for at least the past year

• can speak and write fluent conversational English

• are 18-70 years of age

• are willing to make an attempt to quit smoking and increase physical activity

Exclusion Criteria:

• inability to walk

• expected to have unstable medication regimen during the study

• currently receiving non-study behavioral treatment for smoking

• myocardial infarction in the past 6 months

• contraindication to nicotine replacement therapy (NRT) or bupropion with no medical clearance

• exclusive use of other forms of nicotine such as cigars, pipes, e-cigarettes, or chewing tobacco

• current pregnancy

• current imprisonment or psychiatric hospitalization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27706

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Paul Dennis, PhD, Study Principal Investigator

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 3, 2017

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02873754
• Other Study ID Numbers: Pro00074576
• First Posted: Aug 19, 2016
• Last Update Posted: Jul 13, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Bupropion; Nicotine

Study Results

Participant Flow

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via smart-phone. Cognitive Behavioral Counseling: Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggested activity.
Period Title: Overall Study
STARTED	11
COMPLETED	5
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via smart-phone. Cognitive Behavioral Counseling: Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest activity.
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.45 (10.04)
Sex: Female, Male (Count of Participants)
Female	3 27.3%
Male	8 72.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	11 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	8 72.7%
White	2 18.2%
More than one race	1 9.1%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Self-report Prolonged Abstinence From Smoking
Description	Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	5
Count of Participants [Participants]	3 27.3%

2. Primary Outcome

Title	Number of Participants Whose Prolonged Abstinence is Bio-verified
Description	Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. Two participants didn't self-report abstinence, so bioverification was not completed.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	3
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Number of Participants Who Self-report Prolonged Abstinence From Smoking
Description	Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	5
Count of Participants [Participants]	0 0%

4. Primary Outcome

Title	Number of Participants Whose Prolonged Abstinence is Bio-verified
Description	Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. No participants reported prolonged abstinence, so bioverification wasn't completed.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	0

5. Secondary Outcome

Title	Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Description	7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	5
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
Description	30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	5
Count of Participants [Participants]	0 0%

7. Secondary Outcome

Title	Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
Description	7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	5
Count of Participants [Participants]	0 0%

8. Secondary Outcome

Title	Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
Description	30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	5
Count of Participants [Participants]	0 0%

9. Secondary Outcome

Title	Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.
Description	Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline).
Time Frame	baseline and 3 month follow up

Outcome Measure Data

Analysis Population Description

Data are only available for two participants.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	2
Mean (Standard Deviation) [days]	-3 (4.24)

10. Secondary Outcome

Title	Change in the Number of Days in Which Smoked Compared to Pre-quit Use
Description	Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

These data were only available for one participant.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	1
Number [days]	0

11. Secondary Outcome

Title	Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
Description	Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

Only one participant completed the timeline follow-back procedure at 3 months

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	1
Number [cigarettes]	-22

12. Secondary Outcome

Title	Number of Quit Smoking Attempts
Description	Participants will self-report the number of quit attempts they've had since baseline.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

These data were only available for 2 participants.

Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
Measure Participants	2
Mean (Standard Deviation) [quit attempts]	4.5 (0.7)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	n/a; We utilized clinicaltrials.gov definitions.
Arm/Group Title	STEP UP
Arm/Group Description	STEP UP combines the following: Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity. Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity. Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses). Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch. Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.
All Cause Mortality
	STEP UP
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	STEP UP
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	STEP UP
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

Several participants had early termination. For appropriate outcomes, intent-to-treat analyses were used, wherein missing=presumed smoking.

More Information

Certain Agreements

All Principal Investigators ARE 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.