Clinical trial NCT02873754: Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)
Official title: Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
timeFrame: 6 month follow up
measure: Number of Participants Whose Prolonged Abstinence is Bio-verified
timeFrame: 6 month follow up
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
timeFrame: 3 month follow up
measure: Number of Participants Whose Prolonged Abstinence is Bio-verified
timeFrame: 3 month follow up
Secondary outcomes:
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 month follow up
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 month follow up
measure: Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 3 month follow up
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
timeFrame: 3 month follow up
measure: Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.
timeFrame: baseline and 3 month follow up
measure: Change in the Number of Days in Which Smoked Compared to Pre-quit Use
timeFrame: 3 month follow up
measure: Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
timeFrame: 3 month follow up
measure: Number of Quit Smoking Attempts
timeFrame: 3 month follow up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Study Principal Investigator
name: Paul Dennis, PhD
role: PRINCIPAL_INVESTIGATOR
References: