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

Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity

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).

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Cognitive Behavioral Counseling; Behavioral: Mobile Contingency Management; Drug: Bupropion; Drug: Transdermal nicotine patch; Drug: Nicotine polacrilex; Drug: Nicotine lozenge

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27706
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	3 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 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.	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.	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.	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).	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.	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	3 month follow up
Number of Quit Smoking Attempts	Participants will self-report the number of quit attempts they've had since baseline.	3 month follow up

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Paul Dennis, PhD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion
• Other Study ID Numbers: Pro00074576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No