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

Not Applicable

Completed

Conditions: Smoking

Interventions: Behavioral: Cognitive Behavioral Counseling
Behavioral: Mobile Contingency Management
Drug: Bupropion
Drug: Transdermal nicotine patch
Drug: Nicotine polacrilex
Drug: Nicotine lozenge

Registration Number: NCT02873754

Lead Sponsor: Duke University

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STEP UP	Cognitive Behavioral Counseling	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.
STEP UP	Mobile Contingency Management	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.
STEP UP	Nicotine lozenge	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.
STEP UP	Transdermal nicotine patch	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.
STEP UP	Bupropion	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.
STEP UP	Nicotine polacrilex	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.

Primary Outcome Measures

Name	Time	Method
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.
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

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