Trial Outcomes & Findings for Smoking Treatment and Exercise Program for Underserved Populations (STEP UP) (NCT NCT02873754)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

6 month follow up

Results posted on

2018-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	STEP UP 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.
Overall Study STARTED	11
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	STEP UP 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.
Overall Study Lost to Follow-up	5
Overall Study Couldn't complete study procedures	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STEP UP n=11 Participants 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.
Age, Continuous	43.45 years STANDARD_DEVIATION 10.04 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	11 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 month follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	STEP UP n=5 Participants 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.
Number of Participants Who Self-report Prolonged Abstinence From Smoking	3 Participants

PRIMARY outcome

Timeframe: 6 month follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	STEP UP n=3 Participants 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.
Number of Participants Whose Prolonged Abstinence is Bio-verified	0 Participants

PRIMARY outcome

Timeframe: 3 month follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	STEP UP n=5 Participants 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.
Number of Participants Who Self-report Prolonged Abstinence From Smoking	0 Participants

PRIMARY outcome

Timeframe: 3 month follow up

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month follow up

Population: 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.

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

Outcome measures

Outcome measures
Measure	STEP UP n=5 Participants 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.
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking	0 Participants

SECONDARY outcome

Timeframe: 6 month follow up

Population: 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.

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

Outcome measures

Outcome measures
Measure	STEP UP n=5 Participants 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.
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking	0 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Population: 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.

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

Outcome measures

Outcome measures
Measure	STEP UP n=5 Participants 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.
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking	0 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Population: 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.

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

Outcome measures

Outcome measures
Measure	STEP UP n=5 Participants 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.
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking	0 Participants

SECONDARY outcome

Timeframe: baseline and 3 month follow up

Population: Data are only available for two participants.

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).

Outcome measures

Outcome measures
Measure	STEP UP n=2 Participants 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.
Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.	-3 days Standard Deviation 4.24

SECONDARY outcome

Timeframe: 3 month follow up

Population: These data were only available for one participant.

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.

Outcome measures

Outcome measures
Measure	STEP UP n=1 Participants 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.
Change in the Number of Days in Which Smoked Compared to Pre-quit Use	0 days

SECONDARY outcome

Timeframe: 3 month follow up

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

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

Outcome measures

Outcome measures
Measure	STEP UP n=1 Participants 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.
Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit	-22 cigarettes

SECONDARY outcome

Timeframe: 3 month follow up

Population: These data were only available for 2 participants.

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

Outcome measures

Outcome measures
Measure	STEP UP n=2 Participants 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.
Number of Quit Smoking Attempts	4.5 quit attempts Standard Deviation 0.7

Adverse Events

STEP UP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Kirby

Duke University School of Medicine

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place