<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/NCT03764579</url>
  </required_header>
  <id_info>
    <org_study_id>University of Valencia-POG</org_study_id>
    <nct_id>NCT03764579</nct_id>
  </id_info>
  <brief_title>Dietary Habits and Sleep in Childhood Obesity</brief_title>
  <acronym>INFOB</acronym>
  <official_title>Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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>
      Recruitment of obese children, classification according to sleep questionnaire and&#xD;
      randomization in two groups to perform nutritional and sleep intervention. .&#xD;
&#xD;
      One group receives dietary intervention through recommendations. A group receives dietary and&#xD;
      sleep intervention through recommendations. An analysis of the melatonin profile and&#xD;
      metabolic and inflammatory status is performed by biochemistry at the beginning and end of&#xD;
      the intervention. Determine if the intervention has improved the health of obese children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is carried out in children aged 7 to 14 years who are overweight or obese, in&#xD;
      which their state and circadian rhythm variation are related by means of melatonin,&#xD;
      biochemistry and dietary and sleep questionnaires.&#xD;
&#xD;
      An intervention is performed in which patients are classified in evening and morning. After&#xD;
      the classification, a randomized randomization is carried out in which one group receives&#xD;
      dietary recommendations and another group receives dietary and sleep recommendations. After 6&#xD;
      months of follow-up the analyzes are performed again to observe possible differences with the&#xD;
      initial values and compare it between both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Anticipated">November 29, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 29, 2019</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index measurement, percentile for age and sex</measure>
    <time_frame>6 months</time_frame>
    <description>comparative measurements prior after intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>melatonin concentration profile in saliva</measure>
    <time_frame>6 months</time_frame>
    <description>comparative measurements prior after intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Life Style</condition>
  <condition>Circadian Rhythms</condition>
  <arm_group>
    <arm_group_label>sleep and diet intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>diet intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>sleep and diet intervention vs diet intervention</intervention_name>
    <description>lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.</description>
    <arm_group_label>diet intervention</arm_group_label>
    <arm_group_label>sleep and diet intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children between 7 and 14 years old&#xD;
&#xD;
          -  overweight or obese (Body Mass Index superior to 97th percentile for age and sex).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medicine intake,&#xD;
&#xD;
          -  hyperactivity,&#xD;
&#xD;
          -  infectious inflammatory processes,&#xD;
&#xD;
          -  elite athletes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pilar Codoñer Franch</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PILAR CODOÑER</last_name>
      <phone>+34 670320624</phone>
      <email>pilar.codoner@uv.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Pilar Codoñer-Franch</investigator_full_name>
    <investigator_title>Head of Pediatrics, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT03764579
org study id: University of Valencia-POG
nct id: NCT03764579
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Recruitment of obese children, classification according to sleep questionnaire and
      randomization in two groups to perform nutritional and sleep intervention. .

      One group receives dietary intervention through recommendations. A group receives dietary and
      sleep intervention through recommendations. An analysis of the melatonin profile and
      metabolic and inflammatory status is performed by biochemistry at the beginning and end of
      the intervention. Determine if the intervention has improved the health of obese children.
This study is carried out in children aged 7 to 14 years who are overweight or obese, in
      which their state and circadian rhythm variation are related by means of melatonin,
      biochemistry and dietary and sleep questionnaires.

      An intervention is performed in which patients are classified in evening and morning. After
      the classification, a randomized randomization is carried out in which one group receives
      dietary recommendations and another group receives dietary and sleep recommendations. After 6
      months of follow-up the analyzes are performed again to observe possible differences with the
      initial values and compare it between both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Body mass index measurement, percentile for age and sex
time frame: 6 months
description: comparative measurements prior after intervention
measure: melatonin concentration profile in saliva
time frame: 6 months
description: comparative measurements prior after intervention
arm group label: sleep and diet intervention
arm group type: Active Comparator
arm group label: diet intervention
arm group type: Active Comparator
intervention type: Behavioral
intervention name: sleep and diet intervention vs diet intervention
description: lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
arm group label: diet intervention
arm group label: sleep and diet intervention
criteria: 
gender: All
gender based: Yes
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Pilar Codoñer-Franch
investigator title: Head of Pediatrics, Principal Investigator, Clinical Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No