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/NCT06017856</url>
    </required_header>
    <id_info>
      <org_study_id>MMC-22-0199</org_study_id>
      <nct_id>NCT06017856</nct_id>
    </id_info>
    <brief_title>Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children</brief_title>
    <official_title>The Impact of Physical Exercise and Nutrition on Functional Gastrointestinal Disorders in Obese Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Meir Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Meir Medical Center</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>
        A prospective observational case-control study evaluating the effect of a weight loss&#xD;
        intervention program on functional gastrointestinal disorders among overweight and obese&#xD;
        children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We intend to conduct a prospective observational case-control study of overweight and obese&#xD;
        children, aged 6-18 years, followed in the child health and sport center at Meir medical&#xD;
        center, Kfar-Saba, Israel.&#xD;
  &#xD;
        Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be&#xD;
        offered to participate. Healthy subjects with normal BMI percentile from other pediatric&#xD;
        outpatient clinics as well as relatives and friends of physicians from the pediatric division&#xD;
        will be enrolled and serve as the control group.&#xD;
  &#xD;
        Study visits will be at enrollment and after 3 and 6 months of participation in the&#xD;
        intervention program. During the visits we will collect anthropometric measurements (height,&#xD;
        weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y)&#xD;
        will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. We will&#xD;
        also collect data from exercise capability testing and quality of life questionnaires&#xD;
        performed regularly (and irrespective of this study) during the intervention program.&#xD;
  &#xD;
        We will then compare between subjects who succeeded to those who failed in losing at least 5%&#xD;
        of their initial body weight as well as to healthy controls with normal BMI percentile.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnosis of functional gastrointestinal disorder</measure>
      <time_frame>6 months</time_frame>
      <description>Diagnosis of functional gastrointestinal disorder according to the Rome IV criteria</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Functional Gastrointestinal Disorders</condition>
    <condition>Obesity, Childhood</condition>
    <arm_group>
      <arm_group_label>obese and overweight</arm_group_label>
      <description>Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, participating the in life-style intervention program in the child sport center at Meir medical center</description>
    </arm_group>
    <arm_group>
      <arm_group_label>normal weight</arm_group_label>
      <description>normal weight subjects defined as body mass index (BMI) percentile &lt;85%, with no other chronic conditions</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Life style intervention program</intervention_name>
      <description>Life style intervention program for the obese/overweight subjects conducted regardless of this study at the child sport and health center at Meir medical center</description>
      <arm_group_label>obese and overweight</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          obese and overweight subjects patricipating in the life style modification program as well&#xD;
          as healhy controls of normal weight&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  obese / overweight children participating in the life style modification program at&#xD;
               the child sport and health center&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease,&#xD;
               inflammatory bowel disease)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eyal Zifman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Meir Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eyal Zifman, MD</last_name>
      <phone>+97297471596</phone>
      <email>eyalzi@clalit.org.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Meir Medical Center</name>
        <address>
          <city>Kfar Saba</city>
          <zip>4464402</zip>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Meir Medical Center</investigator_affiliation>
      <investigator_full_name>eyal zifman</investigator_full_name>
      <investigator_title>Head of pediatric gastroeneterogy service</investigator_title>
    </responsible_party>
    <keyword>obese</keyword>
    <keyword>overweight</keyword>
    <keyword>abdominal pain</keyword>
    <keyword>diarrhea</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastrointestinal Diseases</mesh_term>
      <mesh_term>Digestive System Diseases</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06017856
  org study id: MMC-22-0199
  nct id: NCT06017856
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A prospective observational case-control study evaluating the effect of a weight loss
        intervention program on functional gastrointestinal disorders among overweight and obese
        children.
  We intend to conduct a prospective observational case-control study of overweight and obese
        children, aged 6-18 years, followed in the child health and sport center at Meir medical
        center, Kfar-Saba, Israel.
  
        Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be
        offered to participate. Healthy subjects with normal BMI percentile from other pediatric
        outpatient clinics as well as relatives and friends of physicians from the pediatric division
        will be enrolled and serve as the control group.
  
        Study visits will be at enrollment and after 3 and 6 months of participation in the
        intervention program. During the visits we will collect anthropometric measurements (height,
        weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y)
        will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. We will
        also collect data from exercise capability testing and quality of life questionnaires
        performed regularly (and irrespective of this study) during the intervention program.
  
        We will then compare between subjects who succeeded to those who failed in losing at least 5%
        of their initial body weight as well as to healthy controls with normal BMI percentile.
  observational model: Cohort
  time perspective: Prospective
  measure: Diagnosis of functional gastrointestinal disorder
  time frame: 6 months
  description: Diagnosis of functional gastrointestinal disorder according to the Rome IV criteria
  arm group label: obese and overweight
  description: Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, participating the in life-style intervention program in the child sport center at Meir medical center
  arm group label: normal weight
  description: normal weight subjects defined as body mass index (BMI) percentile <85%, with no other chronic conditions
  intervention type: Other
  intervention name: Life style intervention program
  description: Life style intervention program for the obese/overweight subjects conducted regardless of this study at the child sport and health center at Meir medical center
  arm group label: obese and overweight
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eyal Zifman, MD
  role: Principal Investigator
  affiliation: Meir Medical Center
  last name: Eyal Zifman, MD
  phone: +97297471596
  email: eyalzi@clalit.org.il
  facility: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Meir Medical Center
  investigator full name: eyal zifman
  investigator title: Head of pediatric gastroeneterogy service
  mesh term: Gastrointestinal Diseases
  mesh term: Digestive System Diseases
  mesh term: Pediatric Obesity
  sharing ipd: No