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Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers

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ClinicalTrials.gov Identifier: NCT02220465
Recruitment Status : Unknown
Verified January 2014 by Temple University.
Recruitment status was:  Recruiting
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE August 15, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date August 20, 2014
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Smoking Cue Reactivity on Quit Day [ Time Frame: 4-weeks ]
smoking cue reactivity is a behavioral predictor of smoking outcomes. We anticipate that the LMPA intervention will experience greater reductions (extinction) during a controlled, massed cue exposure procedure on their quit day than the Standard care control (SCC) group.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Quit rates at follow ups [ Time Frame: 7 days prior to 1week and 1 month follow up assessments ]
7-day point prevalence abstinence will be assessed using the 7-day timeline follow back administered at 1-week and 1-month follow up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers
Official Title  ICMJE Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
Brief Summary The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.
Detailed Description Tobacco use and lack of physical activity (PA) are preventable health behaviors contributing to disproportionate rates of morbidity/mortality (MM) among low income underserved adults. Comprehensive interventions incorporating treatment of multiple risk behaviors can have immense public health impact. The goal of this study is to improve uptake of PA during the pre-quit period by promoting low to moderate intensity PA (LMPA/walking) during the pre-quit preparatory period to promote smoking cessation among low-income sedentary smokers. Eligible participants (sedentary, >5 cigs/day) will be randomized to 8-week LMPA vs. standard of care (SCC) intervention. LMPA group intervention focuses on (a) increasing daily steps using a tailored algorithm with a goal of reaching 10,000 steps/day by Week 4 (quit day) and (b) integrates PA with evidence-based smoking cessation programming by explicitly linking short bouts of PA with urge management training during the pre-quit period. The SCC group receives standard care smoking cessation counseling. Group differences in quit day reduction (extinction) of smoking urge reactivity using an analog cue-exposure paradigm, and smoking quit rates at 1-week and 1-month follow-up will be examined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sedentary Lifestyle
  • Cigarette Smoking
Intervention  ICMJE
  • Behavioral: PA+ Smoking Cessation (LMPA)
  • Behavioral: Standard Care Smoking Counseling (SCC)
Study Arms  ICMJE
  • Experimental: PA+ Smoking Cessation (LMPA)
    This intervention integrates low-to-moderate physical activity (PA) with evidence based smoking cessation programming. Over the 4-week treatment period, the intervention (1 in-person and 3 phone counseling sessions) focuses on (a) gradually increasing routine PA during the pre-quit period and maintaining PA post quit day (b) increasing daily PA (steps/day) using a weekly tailored algorithm with the goal of achieving 10,000 steps by Week 4 (quit day) and (c) training participants to use PA as a primary urge management strategy, thereby embedding PA within evidence-based smoking cessation counseling. Other components include additional smoking urge management skills, increasing motivation to quit, overcoming barriers and maintaining PA for quitting and staying smoke-free .
    Intervention: Behavioral: PA+ Smoking Cessation (LMPA)
  • Active Comparator: Standard Care Smoking Counseling (SCC)
    The control intervention parallels the format of the LMPA intervention with focus only on behavioral and cognitive urge management strategies (avoiding/escaping high-risk situations, stimulus control) and minimizing the probability that participants in the control group would increase increase/use PA during the intervention period. Participants are provided a pedometer without any instructions or encouragement around increasing walking/steps during the 8-week intervention period.
    Intervention: Behavioral: Standard Care Smoking Counseling (SCC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • intent-to-treat sedentary male and female smokers (intention to quit within the next 6 months) - - - smoke 6 or more cigarettes per day.
  • Sedentary critieria: not purposeful physical activity for less than 20 minutes of vigorous intensity, or less than 60 minutes of moderate intensity physical activity per week, or less than 100 minutes of time spent walking per week.

Exclusion Criteria:

  • pregnancy
  • current substance abuse (e.g., alcohol, cocaine, or stimulants);
  • current diagnosis or treatment of bipolar and psychotic disorder (e.g., use of Haldol, Thorazine).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220465
Other Study ID Numbers  ICMJE 13CRP14560028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Uma S Nair, PhD Temple University
PRS Account Temple University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP