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

Duke University

Status

Completed

Conditions

Smoking

Treatments

Drug: Transdermal nicotine patch

Drug: Bupropion

Behavioral: Cognitive Behavioral Counseling

Drug: Nicotine lozenge

Drug: Nicotine polacrilex

Behavioral: Mobile Contingency Management

Study type

Interventional

Funder types

Other

Identifiers

NCT02873754

Pro00074576

Details and patient eligibility

About

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).

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

STEP UP

Experimental group

Description:

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.