xml: <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/NCT05974514</url>
    </required_header>
    <id_info>
      <org_study_id>29.12.2022/141</org_study_id>
      <nct_id>NCT05974514</nct_id>
    </id_info>
    <brief_title>Body Awareness in Adults With Obesity</brief_title>
    <official_title>Investigation of Physical Parameters Influencing Body Awareness in Adults With Obesity: An Observational, Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fenerbahce University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fenerbahce University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to examine the level of body awareness in individuals&#xD;
        with obesity and investigate the parameters associated with body awareness. In addition,&#xD;
        compare these parameters with healthy subjects with normal weight. The main questions it aims&#xD;
        to answer are:&#xD;
  &#xD;
          -  How is body awareness affected compared to healthy individuals?&#xD;
  &#xD;
          -  Is physical activity level, dynamic balance, proprioception, and reaction time related&#xD;
             to body awareness in individuals with obesity?&#xD;
  &#xD;
          -  Is there any difference between obese and normal-weight individuals in terms of physical&#xD;
             activity level, dynamic balance, proprioception, and reaction time?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 7, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body Awareness</measure>
      <time_frame>Baseline (Only 1 time)</time_frame>
      <description>The Body Awareness Questionnaire will be used to assess body awareness. This questionnaire includes physical, emotional, and social aspects of a person's susceptibility to normal or abnormal bodily conditions and processes, questioning susceptibility to physical reactions. There are 18 statements in the questionnaire, each scored between 1 and 7 points (1=Not at all suitable for me, 7=Completely suitable for me). The total score is 126 and higher indicates a better body awareness level.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical activity level</measure>
      <time_frame>Baseline (Only 1 time)</time_frame>
      <description>To evaluate self-reported physical activity level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used. The IPAQ-SF (7 questions) provides information about time spent on walking, moderate-intensity, and vigorous-intensity activities, as well as time spent sitting. The energy MET-minute score for these activities is calculated using standard MET values, which are as follows: Sitting: 1.5 MET, walking: 3.3 MET, moderate-intensity physical activity: 4.0 MET, vigorous-intensity physical activity: 8.0 MET.&#xD;
  The total MET minutes per week are determined by taking the provided MET value and multiplying it by the total minutes spent engaging in the activity each day. Then, the MET minutes for all the days that the particular activity was performed are added up. Finally, the MET minutes from different activities are added up to get the total MET minutes per week. Physical activity level is categorized as low, moderate, and high.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dynamic balance</measure>
      <time_frame>Baseline (Only 1 time)</time_frame>
      <description>Dynamic balance will be evaluated with the functional reach test. In this test, when standing upright, the distance covered by an extended arm during a complete forward reach, while ensuring a fixed supporting stance is measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proprioception</measure>
      <time_frame>Baseline (Only 1 time)</time_frame>
      <description>The joint position sense assessment will be conducted using a Baseline bubble inclinometer to evaluate proprioception.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reaction time</measure>
      <time_frame>Baseline (Only 1 time)</time_frame>
      <description>The Nelson Foot Reaction Test will be used to evaluate individuals' reaction speed.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Obesity</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study will include 30 individuals with obesity and 30 healthy subjects. The individuals&#xD;
          with obesity will be selected from internal medicine or dietitian clinics in&#xD;
          Istanbul/Turkey.&#xD;
  &#xD;
          Healthy subjects will be age and sex-matched to serve as the control group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults with obesity ((BMI) ≥ 30 kg/m2) aged 18-65 years, who did not receive&#xD;
               obesity-related treatment 6 months before the study&#xD;
  &#xD;
            -  Healthy adults with normal weight (BMI: 18.5-24.9 kg/m2).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Musculoskeletal, neurological, and rheumatological disorders (fractures, sprains or&#xD;
               strains, spine surgery, advanced respiratory or orthopaedic problems),&#xD;
  &#xD;
            -  Malignancy and pregnancy within the last 12 months, which might interfere with&#xD;
               evaluations&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Ezgi Gul, MSc, PT, R.A</last_name>
      <phone>905071180878</phone>
      <email>fzt.ezgigul@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Karaca S, Bayar B. Turkish version of body awareness questionnaire: validity and reliability study. Türk Fizyoterapi ve Rehabilitasyon Dergisi. 2021;32(1):44-50.</citation>
    </reference>
    <reference>
      <citation>Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.</citation>
      <PMID>21058606</PMID>
    </reference>
    <reference>
      <citation>Healey EL, Allen KD, Bennell K, Bowden JL, Quicke JG, Smith R. Self-Report Measures of Physical Activity. Arthritis Care Res (Hoboken). 2020 Oct;72 Suppl 10(Suppl 10):717-730. doi: 10.1002/acr.24211. No abstract available.</citation>
      <PMID>33091242</PMID>
    </reference>
    <reference>
      <citation>Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.</citation>
      <PMID>2229941</PMID>
    </reference>
    <reference>
      <citation>Romero-Franco N, Montano-Munuera JA, Fernandez-Dominguez JC, Jimenez-Reyes P. Validity and Reliability of a Digital Inclinometer to Assess Knee Joint Position Sense in an Open Kinetic Chain. J Sport Rehabil. 2019 May 1;28(4):332-338. doi: 10.1123/jsr.2017-0221. Epub 2018 Dec 12.</citation>
      <PMID>29252090</PMID>
    </reference>
    <reference>
      <citation>Baert IAC, Lluch E, Struyf T, Peeters G, Van Oosterwijck S, Tuynman J, Rufai S, Struyf F. Inter- and intrarater reliability of two proprioception tests using clinical applicable measurement tools in subjects with and without knee osteoarthritis. Musculoskelet Sci Pract. 2018 Jun;35:105-109. doi: 10.1016/j.msksp.2017.11.011. Epub 2017 Nov 21. Erratum In: Musculoskelet Sci Pract. 2023 Feb;63:102683.</citation>
      <PMID>29174222</PMID>
    </reference>
    <reference>
      <citation>Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195.</citation>
      <PMID>24646921</PMID>
    </reference>
    <reference>
      <citation>Tamer K. Sporda fizyolojik fiziksel performansın ölçülmesi ve değerlendirilmesi. Ankara: Bağırgan Yayımevi; 2000</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fenerbahce University</investigator_affiliation>
      <investigator_full_name>Çağdaş IŞIKLAR</investigator_full_name>
      <investigator_title>Lecturer, MSc Physiotherapist (PT)</investigator_title>
    </responsible_party>
    <keyword>Obesity</keyword>
    <keyword>Body awareness</keyword>
    <keyword>Physical activity</keyword>
    <keyword>Balance</keyword>
    <keyword>Proprioception</keyword>
    <keyword>Reaction time</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974514
  org study id: 29.12.2022/141
  nct id: NCT05974514
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to examine the level of body awareness in individuals
        with obesity and investigate the parameters associated with body awareness. In addition,
        compare these parameters with healthy subjects with normal weight. The main questions it aims
        to answer are:
  
          -  How is body awareness affected compared to healthy individuals?
  
          -  Is physical activity level, dynamic balance, proprioception, and reaction time related
             to body awareness in individuals with obesity?
  
          -  Is there any difference between obese and normal-weight individuals in terms of physical
             activity level, dynamic balance, proprioception, and reaction time?
  observational model: Other
  time perspective: Cross-Sectional
  measure: Body Awareness
  time frame: Baseline (Only 1 time)
  description: The Body Awareness Questionnaire will be used to assess body awareness. This questionnaire includes physical, emotional, and social aspects of a person's susceptibility to normal or abnormal bodily conditions and processes, questioning susceptibility to physical reactions. There are 18 statements in the questionnaire, each scored between 1 and 7 points (1=Not at all suitable for me, 7=Completely suitable for me). The total score is 126 and higher indicates a better body awareness level.
  measure: Physical activity level
  time frame: Baseline (Only 1 time)
  description: To evaluate self-reported physical activity level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used. The IPAQ-SF (7 questions) provides information about time spent on walking, moderate-intensity, and vigorous-intensity activities, as well as time spent sitting. The energy MET-minute score for these activities is calculated using standard MET values, which are as follows: Sitting: 1.5 MET, walking: 3.3 MET, moderate-intensity physical activity: 4.0 MET, vigorous-intensity physical activity: 8.0 MET.
  The total MET minutes per week are determined by taking the provided MET value and multiplying it by the total minutes spent engaging in the activity each day. Then, the MET minutes for all the days that the particular activity was performed are added up. Finally, the MET minutes from different activities are added up to get the total MET minutes per week. Physical activity level is categorized as low, moderate, and high.
  measure: Dynamic balance
  time frame: Baseline (Only 1 time)
  description: Dynamic balance will be evaluated with the functional reach test. In this test, when standing upright, the distance covered by an extended arm during a complete forward reach, while ensuring a fixed supporting stance is measured.
  measure: Proprioception
  time frame: Baseline (Only 1 time)
  description: The joint position sense assessment will be conducted using a Baseline bubble inclinometer to evaluate proprioception.
  measure: Reaction time
  time frame: Baseline (Only 1 time)
  description: The Nelson Foot Reaction Test will be used to evaluate individuals' reaction speed.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Ezgi Gul, MSc, PT, R.A
  phone: 905071180878
  email: fzt.ezgigul@gmail.com
  citation: Karaca S, Bayar B. Turkish version of body awareness questionnaire: validity and reliability study. Türk Fizyoterapi ve Rehabilitasyon Dergisi. 2021;32(1):44-50.
  citation: Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
  PMID: 21058606
  citation: Healey EL, Allen KD, Bennell K, Bowden JL, Quicke JG, Smith R. Self-Report Measures of Physical Activity. Arthritis Care Res (Hoboken). 2020 Oct;72 Suppl 10(Suppl 10):717-730. doi: 10.1002/acr.24211. No abstract available.
  PMID: 33091242
  citation: Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.
  PMID: 2229941
  citation: Romero-Franco N, Montano-Munuera JA, Fernandez-Dominguez JC, Jimenez-Reyes P. Validity and Reliability of a Digital Inclinometer to Assess Knee Joint Position Sense in an Open Kinetic Chain. J Sport Rehabil. 2019 May 1;28(4):332-338. doi: 10.1123/jsr.2017-0221. Epub 2018 Dec 12.
  PMID: 29252090
  citation: Baert IAC, Lluch E, Struyf T, Peeters G, Van Oosterwijck S, Tuynman J, Rufai S, Struyf F. Inter- and intrarater reliability of two proprioception tests using clinical applicable measurement tools in subjects with and without knee osteoarthritis. Musculoskelet Sci Pract. 2018 Jun;35:105-109. doi: 10.1016/j.msksp.2017.11.011. Epub 2017 Nov 21. Erratum In: Musculoskelet Sci Pract. 2023 Feb;63:102683.
  PMID: 29174222
  citation: Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195.
  PMID: 24646921
  citation: Tamer K. Sporda fizyolojik fiziksel performansın ölçülmesi ve değerlendirilmesi. Ankara: Bağırgan Yayımevi; 2000
  responsible party type: Principal Investigator
  investigator affiliation: Fenerbahce University
  investigator full name: Çağdaş IŞIKLAR
  investigator title: Lecturer, MSc Physiotherapist (PT)
  mesh term: Obesity