Smoking
Conditions
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.
Interventions
BEHAVIORALCognitive Behavioral Counseling
Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.
BEHAVIORALMobile 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.
DRUGBupropion
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.
DRUGTransdermal nicotine patch
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
DRUGNicotine lozenge
Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 suggest activity. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Couldn't complete study procedures | 1 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | STEP UP |
|---|---|
| Age, Continuous | 43.45 years STANDARD_DEVIATION 10.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Who Self-report Prolonged Abstinence From Smoking | 3 Participants |
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Who Self-report Prolonged Abstinence From Smoking | 0 Participants |
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Whose Prolonged Abstinence is Bio-verified | 0 Participants |
Primary
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
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.
Secondary
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
Population: Only one participant completed the timeline follow-back procedure at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STEP UP | Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit | -22 cigarettes |
Secondary
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
Population: Data are only available for two participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEP UP | 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
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
Population: These data were only available for one participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STEP UP | Change in the Number of Days in Which Smoked Compared to Pre-quit Use | 0 days |
Secondary
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: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking | 0 Participants |
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking | 0 Participants |
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking | 0 Participants |
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEP UP | Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking | 0 Participants |
Secondary
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
Population: These data were only available for 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEP UP | Number of Quit Smoking Attempts | 4.5 quit attempts | Standard Deviation 0.7 |