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SmokingNCT02873754

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

A study testing Cognitive Behavioral Counseling, Mobile Contingency Management and Bupropion in people with Smoking, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Smoking
What is being tested?
Cognitive Behavioral Counseling, Mobile Contingency Management and Bupropion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Jan 2017to Jul 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27706

Other trials in United States

About this study

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

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).

Read the 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
Being tested
Cognitive Behavioral Counseling, Mobile Contingency Management, Bupropion, Transdermal nicotine patch, Nicotine polacrilex
Medical subject headings
Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral CounselingBehavioural

    Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.

  • Mobile Contingency ManagementBehavioural

    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.

  • BupropionDrug

    Also called Zyban

    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 patchDrug

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

  • Nicotine polacrilexDrug

    Also called Nicotine gum; nicorette

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

  • Nicotine lozengeDrug

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

Study groups in NCT02873754
Study groupRoleWhat they receive
STEP UPExperimentalSTEP 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.
Receives: Behavioral: Cognitive Behavioral Counseling; Behavioral: Mobile Contingency Management; Drug: Bupropion; Drug: Transdermal nicotine patch; Drug: Nicotine polacrilex; Drug: Nicotine lozenge

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 6 month follow up

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

    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.

    Measured: 6 month follow up

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

    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.

    Measured: 3 month follow up

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

    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.

    Measured: 3 month follow up

Secondary outcomes (8)

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

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

    Measured: 6 month follow up

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

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

    Measured: 6 month follow up

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

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

    Measured: 3 month follow up

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

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

    Measured: 3 month follow up

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

    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).

    Measured: baseline and 3 month follow up

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

    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.

    Measured: 3 month follow up

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

    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

    Measured: 3 month follow up

  8. Number of Quit Smoking Attempts

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

    Measured: 3 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873754
Sponsor's protocol ID
Pro00074576
Status last verified
Jun 2018
First submitted
17 Aug 2016
Last updated
13 Jul 2018
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Counseling, Mobile Contingency Management and Bupropion in people with Smoking, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Self-report Prolonged Abstinence From Smoking (time frame: 6 month follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.

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