NCT02873754

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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
DRUG	Nicotine lozenge	Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-08-19
• Last updated: 2018-07-13
• Results posted: 2018-07-13

Locations

1 site across 1 country: United States