<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02220465</url>
  </required_header>
  <id_info>
    <org_study_id>13CRP14560028</org_study_id>
    <nct_id>NCT02220465</nct_id>
  </id_info>
  <brief_title>Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers</brief_title>
  <official_title>Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study's primary aim is to test the hypothesis that an intervention that integrates low to&#xD;
      moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA)&#xD;
      will result is greater reductions in quit-day reactivity to smoking cues (a behavioral&#xD;
      predictor of smoking relapse) as compared to standard care smoking cessation counseling&#xD;
      (control group) in a sample of low-income sedentary male and female smokers. The study will&#xD;
      also test the hypothesis that the participants randomized to the LMPA intervention will have&#xD;
      greater quit rates at one-week and one-month post quit day follow ups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tobacco use and lack of physical activity (PA) are preventable health behaviors contributing&#xD;
      to disproportionate rates of morbidity/mortality (MM) among low income underserved adults.&#xD;
      Comprehensive interventions incorporating treatment of multiple risk behaviors can have&#xD;
      immense public health impact. The goal of this study is to improve uptake of PA during the&#xD;
      pre-quit period by promoting low to moderate intensity PA (LMPA/walking) during the pre-quit&#xD;
      preparatory period to promote smoking cessation among low-income sedentary smokers. Eligible&#xD;
      participants (sedentary, &gt;5 cigs/day) will be randomized to 8-week LMPA vs. standard of care&#xD;
      (SCC) intervention. LMPA group intervention focuses on (a) increasing daily steps using a&#xD;
      tailored algorithm with a goal of reaching 10,000 steps/day by Week 4 (quit day) and (b)&#xD;
      integrates PA with evidence-based smoking cessation programming by explicitly linking short&#xD;
      bouts of PA with urge management training during the pre-quit period. The SCC group receives&#xD;
      standard care smoking cessation counseling. Group differences in quit day reduction&#xD;
      (extinction) of smoking urge reactivity using an analog cue-exposure paradigm, and smoking&#xD;
      quit rates at 1-week and 1-month follow-up will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking Cue Reactivity on Quit Day</measure>
    <time_frame>4-weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quit rates at follow ups</measure>
    <time_frame>7 days prior to 1week and 1 month follow up assessments</time_frame>
    <description>7-day point prevalence abstinence will be assessed using the 7-day timeline follow back administered at 1-week and 1-month follow up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>PA+ Smoking Cessation (LMPA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Smoking Counseling (SCC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PA+ Smoking Cessation (LMPA)</intervention_name>
    <arm_group_label>PA+ Smoking Cessation (LMPA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care Smoking Counseling (SCC)</intervention_name>
    <arm_group_label>Standard Care Smoking Counseling (SCC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intent-to-treat sedentary male and female smokers (intention to quit within the next 6&#xD;
             months) - - - smoke 6 or more cigarettes per day.&#xD;
&#xD;
          -  Sedentary critieria: not purposeful physical activity for less than 20 minutes of&#xD;
             vigorous intensity, or less than 60 minutes of moderate intensity physical activity&#xD;
             per week, or less than 100 minutes of time spent walking per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  current substance abuse (e.g., alcohol, cocaine, or stimulants);&#xD;
&#xD;
          -  current diagnosis or treatment of bipolar and psychotic disorder (e.g., use of Haldol,&#xD;
             Thorazine).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uma S Nair, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uma S Nair, PhD</last_name>
    <phone>215-204-6251</phone>
    <email>uma.nair@temple.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Temple university</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Uma Nair, PhD</last_name>
      <phone>215-204-6251</phone>
      <email>uma.nair@temple.edu</email>
    </contact>
    <contact_backup>
      <last_name>Bradley N Collins, phD</last_name>
      <email>collinsb@temple.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Uma S Nair, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sedentary</keyword>
  <keyword>smoking</keyword>
  <keyword>cue reactivity</keyword>
  <keyword>physical activity</keyword>
  <pending_results>
    <submitted>June 19, 2017</submitted>
    <returned>November 14, 2017</returned>
    <submitted>April 24, 2018</submitted>
    <returned>November 9, 2018</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02220465
org study id: 13CRP14560028
nct id: NCT02220465
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Smoking Cue Reactivity on Quit Day
time frame: 4-weeks
description: 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.
measure: Quit rates at follow ups
time frame: 7 days prior to 1week and 1 month follow up assessments
description: 7-day point prevalence abstinence will be assessed using the 7-day timeline follow back administered at 1-week and 1-month follow up.
arm group label: PA+ Smoking Cessation (LMPA)
arm group type: Experimental
description: 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 .
arm group label: Standard Care Smoking Counseling (SCC)
arm group type: Active Comparator
description: 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 type: Behavioral
intervention name: PA+ Smoking Cessation (LMPA)
arm group label: PA+ Smoking Cessation (LMPA)
intervention type: Behavioral
intervention name: Standard Care Smoking Counseling (SCC)
arm group label: Standard Care Smoking Counseling (SCC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uma S Nair, PhD
role: Principal Investigator
affiliation: Temple University
last name: Uma S Nair, PhD
phone: 215-204-6251
email: uma.nair@temple.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
submitted: June 19, 2017
returned: November 14, 2017
submitted: April 24, 2018
returned: November 9, 2018