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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

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Cigarette Smoking Behavioral: PA+ Smoking Cessation (LMPA) Behavioral: Standard Care Smoking Counseling (SCC) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
Study Start Date : April 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 .
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.
Behavioral: Standard Care Smoking Counseling (SCC)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220465


Contacts
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Contact: Uma S Nair, PhD 215-204-6251 uma.nair@temple.edu

Locations
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United States, Pennsylvania
Temple university Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Uma Nair, PhD    215-204-6251    uma.nair@temple.edu   
Contact: Bradley N Collins, phD       collinsb@temple.edu   
Principal Investigator: Uma S Nair, PhD         
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Uma S Nair, PhD Temple University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02220465    
Other Study ID Numbers: 13CRP14560028
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: January 2014
Keywords provided by Temple University:
sedentary
smoking
cue reactivity
physical activity