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

NCT ID: NCT02873754

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-07-31

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.

Conditions

Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Counseling

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Bupropion

Intervention Type: DRUG

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.

Transdermal nicotine patch

Intervention Type: DRUG

Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant

Nicotine polacrilex

Intervention Type: DRUG

Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed

Nicotine lozenge

Intervention Type: DRUG

Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Transdermal nicotine patch

Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant

Intervention Type: DRUG

Nicotine polacrilex

Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed

Intervention Type: DRUG

Nicotine lozenge

Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed

Intervention Type: DRUG

Other Intervention Names

Zyban; Nicotine gum; nicorette

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Dennis, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00074576

Identifier Type: -

Identifier Source: org_study_id