<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/NCT01722357</url>
  </required_header>
  <id_info>
    <org_study_id>09110</org_study_id>
    <nct_id>NCT01722357</nct_id>
  </id_info>
  <brief_title>Promoting Physical Activity Among Bariatric Surgery Patients</brief_title>
  <official_title>Promoting Physical Activity Among Bariatric Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascension St. Vincent Carmel Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Vincent Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ascension St. Vincent Carmel Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to address 3 main sets of questions in the bariatric surgery&#xD;
      population. 1) Does bariatric surgery, without any other intervention, lead to increased&#xD;
      physical activity and improved physical fitness? 2) Does wearing a pedometer lead to&#xD;
      increased physical activity in obese individuals prior to and/or after bariatric surgery?&#xD;
      Does the increased activity result in improvements in physical fitness? 3) Does physical&#xD;
      activity counseling increase physical activity prior to and or/after bariatric surgery? Does&#xD;
      the increased activity result in improvements in physical fitness? The overall goal of the&#xD;
      study is to determine the impact of bariatric surgery on physical activity and assess the&#xD;
      utility of additional interventions to help postoperative patients adopt a more active&#xD;
      lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus&#xD;
      exercise counseling before and for the first 6 months after bariatric surgery. In an&#xD;
      extension of the primary study, from 1 to 5 years after surgery, all patients receive&#xD;
      exercise counseling. Physiological measures will be assessed to determine whether bariatric&#xD;
      surgery and/or improved physical activity levels result in improved physical fitness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bariatric surgery leads to improvement or resolution of a variety of health conditions. It is&#xD;
      also well established that physical activity, with or without weight loss, improves many&#xD;
      health-related problems and can have a positive impact on mood. Therefore, physical activity&#xD;
      may amplify the health and psychological benefits often experienced from bariatric surgery.&#xD;
      Prior to surgery many patients are relatively inactive due to physical and social barriers&#xD;
      associated with their weight. In addition, many patients find it difficult to adopt an active&#xD;
      lifestyle after surgery, despite an increased capacity to exercise. However, weight loss is&#xD;
      associated with physical activity after bariatric surgery. Nonetheless, little is known about&#xD;
      the most effective means to promote activity among this group of individuals. This study will&#xD;
      examine changes in physical activity and fitness after bariatric surgery and examine whether&#xD;
      the addition of pedometer use and exercise counseling may lead to greater improvements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2009</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accelerometer-Derived Activity</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>accelerometer-derived activity will be collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graded Treadmill Test</measure>
    <time_frame>baseline, 6 months and 5 years post-surgery</time_frame>
    <description>length of time participant walks on treadmill until reaching percieved exertion or heart rate target</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Body Strength testing</measure>
    <time_frame>baseline, 6 months and 5 years post-surgery</time_frame>
    <description>hand grip and chest press</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baecke Habitual Physical Activity Questionnaire</measure>
    <time_frame>baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myers-Roth Benefits and Barriers of Exercise Questionnaire</measure>
    <time_frame>baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ-9 Symptom Checklist</measure>
    <time_frame>baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery</time_frame>
    <description>measure of depressed mood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St.Vincent Exercise Questionnaire</measure>
    <time_frame>baseline , 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Identity Scale</measure>
    <time_frame>12 and 18 months, and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NEO-IPIP Conscientiousness Scale</measure>
    <time_frame>12 and 18 months, and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thoughts of Exercise Scale</measure>
    <time_frame>12 and 18 months, and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accelerometer-Derived Activity</measure>
    <time_frame>baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Vital signs</measure>
    <time_frame>baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery</time_frame>
    <description>weight, blood pressure, pulse, respiratory rate</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Pedometer + Exercise Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pedometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Self-help information provided on physical activity (WIN:Weight Control Network &quot;Active At Any Size&quot; provided by National Institute of Diabetes and Digestive and Kidney Diseases, 2006).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pedometer</intervention_name>
    <description>Participants are provided with Omron Model HJ-151 pedometers and given instruction on how to use the pedometer to set goals for increasing physical activity. They are given diaries to track their daily step counts.</description>
    <arm_group_label>Pedometer</arm_group_label>
    <arm_group_label>Pedometer + Exercise Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Counseling</intervention_name>
    <description>Manualized cognitive behavioral treatment program including goal setting, adding exercise throughout the day, physical limitations/injuries, maintaining motivation, benefits of exercise, FITT principles, exercise as recreation, and restructuring thoughts related to activity.</description>
    <arm_group_label>Pedometer + Exercise Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbidly obese patients planning to undergo bariatric surgery at the St. Vincent&#xD;
             Bariatric Center of Excellence&#xD;
&#xD;
          -  Men and women 18 years and older&#xD;
&#xD;
          -  The participant must be motivated to enroll in a study assessing physical activity&#xD;
             before and after bariatric surgery, able to understand and comply with the study, and&#xD;
             must agree to return for scheduled visits&#xD;
&#xD;
          -  All participants must sign a written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of myocardial infarction within the past three months, unstable angina&#xD;
             pectoris, sustained or episodic cardiac arrhythmias that could be aggravated by&#xD;
             physical activity, symptomatic peripheral vascular disease, or any other medical&#xD;
             condition that the medically responsible investigator deems inappropriate.&#xD;
&#xD;
          -  Abnormal electrocardiogram (ECG), assessed at the pretreatment screening visit that&#xD;
             the medically responsible investigator deems inappropriate for participation in a&#xD;
             physical activity program.&#xD;
&#xD;
          -  Unable to progress toward 30 minutes of continuous walking during the 6 months of&#xD;
             study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David B Creel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Vincent Carmel Hospital Bariatric Center of Excellence</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincent Carmel Hospital Bariatric Center of Excellence</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Creel DB, Schuh LM, Reed CA, Gomez AR, Hurst LA, Stote J, Cacucci BM. A randomized trial comparing two interventions to increase physical activity among patients undergoing bariatric surgery. Obesity (Silver Spring). 2016 Aug;24(8):1660-8. doi: 10.1002/oby.21548. Epub 2016 Jul 1.</citation>
    <PMID>27367821</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bariatric surgery</keyword>
  <keyword>physical activity</keyword>
  <keyword>morbid obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01722357
org study id: 09110
nct id: NCT01722357
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to address 3 main sets of questions in the bariatric surgery
      population. 1) Does bariatric surgery, without any other intervention, lead to increased
      physical activity and improved physical fitness? 2) Does wearing a pedometer lead to
      increased physical activity in obese individuals prior to and/or after bariatric surgery?
      Does the increased activity result in improvements in physical fitness? 3) Does physical
      activity counseling increase physical activity prior to and or/after bariatric surgery? Does
      the increased activity result in improvements in physical fitness? The overall goal of the
      study is to determine the impact of bariatric surgery on physical activity and assess the
      utility of additional interventions to help postoperative patients adopt a more active
      lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus
      exercise counseling before and for the first 6 months after bariatric surgery. In an
      extension of the primary study, from 1 to 5 years after surgery, all patients receive
      exercise counseling. Physiological measures will be assessed to determine whether bariatric
      surgery and/or improved physical activity levels result in improved physical fitness.
Bariatric surgery leads to improvement or resolution of a variety of health conditions. It is
      also well established that physical activity, with or without weight loss, improves many
      health-related problems and can have a positive impact on mood. Therefore, physical activity
      may amplify the health and psychological benefits often experienced from bariatric surgery.
      Prior to surgery many patients are relatively inactive due to physical and social barriers
      associated with their weight. In addition, many patients find it difficult to adopt an active
      lifestyle after surgery, despite an increased capacity to exercise. However, weight loss is
      associated with physical activity after bariatric surgery. Nonetheless, little is known about
      the most effective means to promote activity among this group of individuals. This study will
      examine changes in physical activity and fitness after bariatric surgery and examine whether
      the addition of pedometer use and exercise counseling may lead to greater improvements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Accelerometer-Derived Activity
time frame: 6 months post-surgery
description: accelerometer-derived activity will be collected.
measure: Graded Treadmill Test
time frame: baseline, 6 months and 5 years post-surgery
description: length of time participant walks on treadmill until reaching percieved exertion or heart rate target
measure: Upper Body Strength testing
time frame: baseline, 6 months and 5 years post-surgery
description: hand grip and chest press
measure: Baecke Habitual Physical Activity Questionnaire
time frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: Myers-Roth Benefits and Barriers of Exercise Questionnaire
time frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: PHQ-9 Symptom Checklist
time frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
description: measure of depressed mood
measure: St.Vincent Exercise Questionnaire
time frame: baseline , 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: Exercise Identity Scale
time frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery
measure: NEO-IPIP Conscientiousness Scale
time frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery
measure: Thoughts of Exercise Scale
time frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery
measure: Accelerometer-Derived Activity
time frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: Vital signs
time frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
description: weight, blood pressure, pulse, respiratory rate
arm group label: Pedometer + Exercise Counseling
arm group type: Experimental
arm group label: Pedometer
arm group type: Experimental
arm group label: Usual Care
arm group type: No Intervention
description: Self-help information provided on physical activity (WIN:Weight Control Network "Active At Any Size" provided by National Institute of Diabetes and Digestive and Kidney Diseases, 2006).
intervention type: Behavioral
intervention name: Pedometer
description: Participants are provided with Omron Model HJ-151 pedometers and given instruction on how to use the pedometer to set goals for increasing physical activity. They are given diaries to track their daily step counts.
arm group label: Pedometer
arm group label: Pedometer + Exercise Counseling
intervention type: Behavioral
intervention name: Exercise Counseling
description: Manualized cognitive behavioral treatment program including goal setting, adding exercise throughout the day, physical limitations/injuries, maintaining motivation, benefits of exercise, FITT principles, exercise as recreation, and restructuring thoughts related to activity.
arm group label: Pedometer + Exercise Counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David B Creel, PhD
role: Principal Investigator
affiliation: St. Vincent Carmel Hospital Bariatric Center of Excellence
facility: 
country: United States
citation: Creel DB, Schuh LM, Reed CA, Gomez AR, Hurst LA, Stote J, Cacucci BM. A randomized trial comparing two interventions to increase physical activity among patients undergoing bariatric surgery. Obesity (Silver Spring). 2016 Aug;24(8):1660-8. doi: 10.1002/oby.21548. Epub 2016 Jul 1.
PMID: 27367821
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: Undecided