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

NCT02873754 | Completed Results

• 1 other identifier: Pro00074576
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking

Outcome Measures

Primary Outcomes (4)

• 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.

  6 month follow up

• 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.

  6 month follow up

• 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.

  3 month follow up

• 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.

  3 month follow up

Secondary Outcomes (8)

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

  6 month follow up

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

  6 month follow up

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

  3 month follow up

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

  3 month follow up

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

  baseline and 3 month follow up

Study Arms (1)

STEP UP

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Counseling; Behavioral: Mobile Contingency Management; Drug: Bupropion; Drug: Transdermal nicotine patch; Drug: Nicotine polacrilex; Drug: Nicotine lozenge

Interventions

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.

STEP UP

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.

STEP UP

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.

Also known as: Zyban

STEP UP

Transdermal nicotine patch DRUG

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

STEP UP

Nicotine polacrilex DRUG

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

Also known as: Nicotine gum; nicorette

STEP UP

Nicotine lozenge DRUG

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

STEP UP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Bupropion; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Several participants had early termination. For appropriate outcomes, intent-to-treat analyses were used, wherein missing=presumed smoking.

Results Point of Contact

• Title: Angela Kirby
• Organization: Duke University School of Medicine

angela.kirby@duke.edu

919-286-0411

Study Officials

• Paul Dennis, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 19, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 13, 2018
• Results First Posted: July 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)