<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/NCT03022474</url>
  </required_header>
  <id_info>
    <org_study_id>20121A011070</org_study_id>
    <nct_id>NCT03022474</nct_id>
  </id_info>
  <brief_title>Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG)</brief_title>
  <acronym>KICOG</acronym>
  <official_title>Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early life interventions for childhood obesity may provide substantial benefits. Most&#xD;
      existing studies aimed at school children have reported limited effectiveness, however few&#xD;
      have targeted preschool children. This study aimed to pilot procedures for a multifaceted,&#xD;
      culturally appropriate intervention for preschool children and to provide a preliminary&#xD;
      assessment of effectiveness of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention protocol was developed by an expert group from the National Children Obesity&#xD;
      Intervention Team, comprising pediatricians, children healthcare doctors, preschool teachers,&#xD;
      and nutritionists, and included three integrated components:&#xD;
&#xD;
      Component 1 - training of kindergarten staff: Before the start of the program, two members of&#xD;
      the intervention team (a dietitian and a physician) delivered eight 40-min sessions (twice a&#xD;
      week for a month) on dietary management in children and daily food purchasing for school&#xD;
      doctors and kitchen staff. During the trial, two health education doctors gave lectures every&#xD;
      two months on general knowledge in nutrition to all preschool staff, focusing on the&#xD;
      promotion of healthy food and restriction of unhealthy food. To assess the effectiveness of&#xD;
      these lectures, we administered a questionnaire on the material covered. We also trained the&#xD;
      kitchen staff to use the dietary software to plan menu with balanced nutrition for preschool&#xD;
      children.&#xD;
&#xD;
      Component 2 - a curriculum promoting healthy diet and lifestyle: We designed a health&#xD;
      education curriculum and associated picture books for the children. Children in the&#xD;
      intervention group received a 20-minute health education lesson every week, where they had&#xD;
      learning activities and games covering healthy food choice, appropriate portion sizes and&#xD;
      eating pace, and reduction of sedentary behaviours. Learning aids such as colourful picture&#xD;
      books or cards, food models, nursery rhymes and stories were used. Two elements were&#xD;
      introduce to increase children's activity such as lunchtime activity and daily dance at less&#xD;
      than 10 minutes during break.&#xD;
&#xD;
      Component 3 - collaboration between families and kindergartens: We organized lectures&#xD;
      designed for parents every two months during the intervention period. Topics covered included&#xD;
      the cause and harms of childhood obesity, advice on healthy diet (increasing consumption of&#xD;
      vegetables and fruits, reducing consumption of meat, snacks, fast foods, and eating out, and&#xD;
      avoiding sugary drinks), body mass index (BMI) reference for preschool-age children, and how&#xD;
      to use growth curves. We produced a handbook for communication between families and schools,&#xD;
      to be handed out to every family weekly, in which children's health behaviours were&#xD;
      documented and reviewed by teachers and parents. Finally, parents were notified of their&#xD;
      children's anthropometric measurements every three months, so that they could plot and&#xD;
      interpret their children's growth curves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index (BMI) change</measure>
    <time_frame>BMI was measured at baseline and one year after intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI Z-score change</measure>
    <time_frame>BMI Z-score was measured and calculated at baseline and one year after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility and acceptability of the intervention</measure>
    <time_frame>During intervention</time_frame>
    <description>Qualitatively describe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">984</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Lifestyles Intervention</intervention_name>
    <description>The program included three major components. The first component consists of live lectures to kindergarten staff about basic nutrition and food concepts that attempted to correct false beliefs. The second component was a health curriculum for children that focused on promoting healthy nutrition habits and a healthy living style. Preschools were required to ensure that children received a health education lesson every two weeks. The third component was aimed at educating parents and consisted of lectures every two months, preschool-home communication every week and child growth monitoring every three months.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (i) run by the government (public kindergarten); (ii) located in the central area of the&#xD;
        district; (iii) had no less than 100 students; (iv)had no less than two school doctors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiu Qiu, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Guangzhou Women and Children's Medical Center, China</affiliation>
  </overall_official>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>March 24, 2017</last_update_submitted>
  <last_update_submitted_qc>March 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Xiu Qiu</investigator_full_name>
    <investigator_title>Healthcare Department Director</investigator_title>
  </responsible_party>
  <keyword>Childhood obesity</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>
  <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/NCT03022474
org study id: 20121A011070
nct id: NCT03022474
lead sponsor: 
has dmc: Yes
Early life interventions for childhood obesity may provide substantial benefits. Most
      existing studies aimed at school children have reported limited effectiveness, however few
      have targeted preschool children. This study aimed to pilot procedures for a multifaceted,
      culturally appropriate intervention for preschool children and to provide a preliminary
      assessment of effectiveness of the intervention.
The intervention protocol was developed by an expert group from the National Children Obesity
      Intervention Team, comprising pediatricians, children healthcare doctors, preschool teachers,
      and nutritionists, and included three integrated components:

      Component 1 - training of kindergarten staff: Before the start of the program, two members of
      the intervention team (a dietitian and a physician) delivered eight 40-min sessions (twice a
      week for a month) on dietary management in children and daily food purchasing for school
      doctors and kitchen staff. During the trial, two health education doctors gave lectures every
      two months on general knowledge in nutrition to all preschool staff, focusing on the
      promotion of healthy food and restriction of unhealthy food. To assess the effectiveness of
      these lectures, we administered a questionnaire on the material covered. We also trained the
      kitchen staff to use the dietary software to plan menu with balanced nutrition for preschool
      children.

      Component 2 - a curriculum promoting healthy diet and lifestyle: We designed a health
      education curriculum and associated picture books for the children. Children in the
      intervention group received a 20-minute health education lesson every week, where they had
      learning activities and games covering healthy food choice, appropriate portion sizes and
      eating pace, and reduction of sedentary behaviours. Learning aids such as colourful picture
      books or cards, food models, nursery rhymes and stories were used. Two elements were
      introduce to increase children's activity such as lunchtime activity and daily dance at less
      than 10 minutes during break.

      Component 3 - collaboration between families and kindergartens: We organized lectures
      designed for parents every two months during the intervention period. Topics covered included
      the cause and harms of childhood obesity, advice on healthy diet (increasing consumption of
      vegetables and fruits, reducing consumption of meat, snacks, fast foods, and eating out, and
      avoiding sugary drinks), body mass index (BMI) reference for preschool-age children, and how
      to use growth curves. We produced a handbook for communication between families and schools,
      to be handed out to every family weekly, in which children's health behaviours were
      documented and reviewed by teachers and parents. Finally, parents were notified of their
      children's anthropometric measurements every three months, so that they could plot and
      interpret their children's growth curves.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Body mass index (BMI) change
time frame: BMI was measured at baseline and one year after intervention
measure: BMI Z-score change
time frame: BMI Z-score was measured and calculated at baseline and one year after intervention
measure: Feasibility and acceptability of the intervention
time frame: During intervention
description: Qualitatively describe
arm group label: Intervention group
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Healthy Lifestyles Intervention
description: The program included three major components. The first component consists of live lectures to kindergarten staff about basic nutrition and food concepts that attempted to correct false beliefs. The second component was a health curriculum for children that focused on promoting healthy nutrition habits and a healthy living style. Preschools were required to ensure that children received a health education lesson every two weeks. The third component was aimed at educating parents and consisted of lectures every two months, preschool-home communication every week and child growth monitoring every three months.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: No
last name: Xiu Qiu, Doctor
role: Study Director
affiliation: Guangzhou Women and Children's Medical Center, China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Xiu Qiu
investigator title: Healthcare Department Director
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No