<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/NCT03819673</url>
  </required_header>
  <id_info>
    <org_study_id>e-tool for childhood obesity</org_study_id>
    <nct_id>NCT03819673</nct_id>
  </id_info>
  <brief_title>Computerised Decision-Support Tool for Childhood Obesity Management</brief_title>
  <official_title>A Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harokopio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study was to examine the effectiveness of a computerised&#xD;
      decision-support tool, developed to assist paediatric clinicians in delivering personalised&#xD;
      nutrition and lifestyle optimization advice to children and their families, as a means of&#xD;
      childhood obesity management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the present study was to examine the effectiveness of a computerised&#xD;
      decision-support tool, developed to assist paediatric clinicians in delivering personalised&#xD;
      nutrition and lifestyle optimization advice to children and their families, as a means of&#xD;
      childhood obesity management.&#xD;
&#xD;
      The effectiveness of the decision support tool was assessed through a pilot randomized&#xD;
      controlled intervention trial (RCT). The RCT was initiated on May 2018 and was conducted in&#xD;
      the Endocrinology Department of the &quot;P. A. Kyriakou&quot; Children's Hospital and in the Division&#xD;
      of Endocrinology, Metabolism, and Diabetes of the &quot;Aghia Sophia&quot; Children's Hospital in&#xD;
      Athens, Greece.&#xD;
&#xD;
      Sixty-five overweight or obese children that were eligible to participate in the RCT, were&#xD;
      randomly and equally allocated to two study groups. Those children that were randomly&#xD;
      allocated to the intervention group (IG), were examined by health professionals (i.e.&#xD;
      paediatricians, paediatric endocrinologists and a dietitian) who were trained in the use of&#xD;
      the decision support tool. The latter assisted the medical professionals to assess children's&#xD;
      weight status, to set appropriate weight management goals and provide personalised meal plans&#xD;
      and/or recommendations to children and their families. On the contrary, those children that&#xD;
      were randomly allocated to the control group (CG) received the usual care advice that is&#xD;
      routinely provided to children in the two hospitals and includes child visits and follow-up&#xD;
      appointments for weight checks with their primary care provider or dietitian.&#xD;
&#xD;
      The effectiveness of the intervention was evaluated through the collection of data at&#xD;
      baseline and at a follow-up examination after 3 months.&#xD;
&#xD;
      All data were uploaded to the decision-support tool, which analysed them and extracted a&#xD;
      report with the child's assessment, as well as with personalised diet and lifestyle&#xD;
      optimization recommendations. More specifically, the decision support tool proposed&#xD;
      personalised weekly meal plans adjusted to the estimated energy requirements calculated for&#xD;
      each child, as well as personalised diet and lifestyle optimization advice recommendations&#xD;
      for the child and/or the entire family. Lastly, the decision support tool suggested a&#xD;
      periodic re-evaluation every 3 or 6 months depending on the child's current weight status,&#xD;
      the presence of obesity-related comorbidity in children and the presence of obesity in at&#xD;
      least one or both parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Body Mass Index (BMI)</measure>
    <time_frame>3-6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention Group (IG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Care based on the computerised decision-support tool</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care advice by primary care provider or dietitian of participating hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Group Care</intervention_name>
    <description>children's assessment, setting weight management goals, provision of personalised meal plans, personalised diet and lifestyle optimization advice recommendations to children and their families, periodic re-evaluation every 3 or 6 months</description>
    <arm_group_label>Intervention Group (IG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6-12 years old&#xD;
&#xD;
          -  Overweight status or obesity (i.e. BMI-for-age &gt; 85th percentile)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age range not within the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yannis Manios, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harokopio University, Athens, Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George Moschonis, Associate Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>La Trobe University, Bundoora, VIC 3086, Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harokopio University of Athens</name>
      <address>
        <city>Kallithea</city>
        <state>Attica</state>
        <zip>17671</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harokopio University</investigator_affiliation>
    <investigator_full_name>Yannis Manios</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Personalised</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Intervention</keyword>
  <keyword>Children</keyword>
  <keyword>Obesity</keyword>
  <keyword>Health professionals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT03819673
org study id: e-tool for childhood obesity
nct id: NCT03819673
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the present study was to examine the effectiveness of a computerised
      decision-support tool, developed to assist paediatric clinicians in delivering personalised
      nutrition and lifestyle optimization advice to children and their families, as a means of
      childhood obesity management.
The objective of the present study was to examine the effectiveness of a computerised
      decision-support tool, developed to assist paediatric clinicians in delivering personalised
      nutrition and lifestyle optimization advice to children and their families, as a means of
      childhood obesity management.

      The effectiveness of the decision support tool was assessed through a pilot randomized
      controlled intervention trial (RCT). The RCT was initiated on May 2018 and was conducted in
      the Endocrinology Department of the "P. A. Kyriakou" Children's Hospital and in the Division
      of Endocrinology, Metabolism, and Diabetes of the "Aghia Sophia" Children's Hospital in
      Athens, Greece.

      Sixty-five overweight or obese children that were eligible to participate in the RCT, were
      randomly and equally allocated to two study groups. Those children that were randomly
      allocated to the intervention group (IG), were examined by health professionals (i.e.
      paediatricians, paediatric endocrinologists and a dietitian) who were trained in the use of
      the decision support tool. The latter assisted the medical professionals to assess children's
      weight status, to set appropriate weight management goals and provide personalised meal plans
      and/or recommendations to children and their families. On the contrary, those children that
      were randomly allocated to the control group (CG) received the usual care advice that is
      routinely provided to children in the two hospitals and includes child visits and follow-up
      appointments for weight checks with their primary care provider or dietitian.

      The effectiveness of the intervention was evaluated through the collection of data at
      baseline and at a follow-up examination after 3 months.

      All data were uploaded to the decision-support tool, which analysed them and extracted a
      report with the child's assessment, as well as with personalised diet and lifestyle
      optimization recommendations. More specifically, the decision support tool proposed
      personalised weekly meal plans adjusted to the estimated energy requirements calculated for
      each child, as well as personalised diet and lifestyle optimization advice recommendations
      for the child and/or the entire family. Lastly, the decision support tool suggested a
      periodic re-evaluation every 3 or 6 months depending on the child's current weight status,
      the presence of obesity-related comorbidity in children and the presence of obesity in at
      least one or both parents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body Mass Index (BMI)
time frame: 3-6 months
arm group label: Intervention Group (IG)
arm group type: Experimental
description: Care based on the computerised decision-support tool
arm group label: Control Group (CG)
arm group type: No Intervention
description: Usual care advice by primary care provider or dietitian of participating hospital
intervention type: Behavioral
intervention name: Intervention Group Care
description: children's assessment, setting weight management goals, provision of personalised meal plans, personalised diet and lifestyle optimization advice recommendations to children and their families, periodic re-evaluation every 3 or 6 months
arm group label: Intervention Group (IG)
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yannis Manios, Professor
role: Principal Investigator
affiliation: Harokopio University, Athens, Greece
last name: George Moschonis, Associate Professor
role: Principal Investigator
affiliation: La Trobe University, Bundoora, VIC 3086, Australia
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Harokopio University
investigator full name: Yannis Manios
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Pediatric Obesity