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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.
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.
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.
Duke University Medical Center
Durham, North Carolina, United States
Number of Participants Who Self-report Prolonged Abstinence From Smoking
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
Number of Participants Whose Prolonged Abstinence is Bio-verified
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
Number of Participants Who Self-report Prolonged Abstinence From Smoking
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
Number of Participants Whose Prolonged Abstinence is Bio-verified
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
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time frame: 6 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
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Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed
Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time frame: 6 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time frame: 3 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time frame: 3 month follow up
Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.
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
Change in the Number of Days in Which Smoked Compared to Pre-quit Use
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
Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
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
Number of Quit Smoking Attempts
Participants will self-report the number of quit attempts they've had since baseline.
Time frame: 3 month follow up