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Completed

NCT Number: NCT02873754

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

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).

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Key information

Conditions

Smoking Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Counseling

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

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

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.

Other names: Zyban

Transdermal Nicotine Patch

Drug

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

Nicotine polacrilex

Drug

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

Other names: Nicotine gum; nicorette

Nicotine Lozenge

Drug

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

Primary outcomes

  1. Number of Participants Who Self-report Prolonged Abstinence From Smoking

    Time frame: 6 month follow up

    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.

  2. Number of Participants Whose Prolonged Abstinence is Bio-verified

    Time frame: 6 month follow up

    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. Number of Participants Who Self-report Prolonged Abstinence From Smoking

    Time frame: 3 month follow up

    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.

  4. Number of Participants Whose Prolonged Abstinence is Bio-verified

    Time frame: 3 month follow up

    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.

Secondary outcomes

  1. Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking

    Time frame: 6 month follow up

    7-day point prevalence abstinence is defined as no smoking in the prior 7 days.

  2. Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking

    Time frame: 6 month follow up

    30-day point prevalence abstinence is defined as no smoking in the prior 30 days.

  3. Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking

    Time frame: 3 month follow up

    7-day point prevalence abstinence is defined as no smoking in the prior 7 days.

  4. Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking

    Time frame: 3 month follow up

    30-day point prevalence abstinence is defined as no smoking in the prior 30 days.

  5. Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.

    Time frame: baseline and 3 month follow up

    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).

  6. Change in the Number of Days in Which Smoked Compared to Pre-quit Use

    Time frame: 3 month follow up

    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.

  7. Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit

    Time frame: 3 month follow up

    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

  8. Number of Quit Smoking Attempts

    Time frame: 3 month follow up

    Participants will self-report the number of quit attempts they've had since baseline.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2016
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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