<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/NCT02228434</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00001052-10081</org_study_id>
    <nct_id>NCT02228434</nct_id>
  </id_info>
  <brief_title>Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors</brief_title>
  <official_title>Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wang Jingjing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <brief_summary>
    <textblock>
      The project aims at developing the tailored intervention strategy of childhood obesity based&#xD;
      on monitoring physical activities with accelerometer and dietary behaviors using diary. It&#xD;
      probably raise the passion of obese children to control weight, form healthy life style, be&#xD;
      effective in sustaining weight loss and early prevent adulthood diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overweight and obese primary school students from 1-5 grades will be recruited according&#xD;
      to &quot;Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age&#xD;
      Children&quot;. The participants with will be allocated with schools as the unit to four groups:&#xD;
      tailored intervention based on monitoring physical activity and dietary behaviors, exercise&#xD;
      intervention group based on the Happy 10 program, nutrition education intervention group. The&#xD;
      three intervention groups received the designed interventions for the duration of 1 year.&#xD;
      Before and after the intervention, we will carry out a questionnaire survey, a physical&#xD;
      measurement, a fitness test, and a metabolic markers detection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <primary_completion_date type="Actual">December 2011</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>Baseline, 1-year post-intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in obesity-related anthropometric measurements</measure>
    <time_frame>Baseline, 1-year post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of blood pressure</measure>
    <time_frame>Baseline, 1-year post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of biomarkers for disease risk</measure>
    <time_frame>Baseline, 1-year post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of attitude, knowledge, and behaviors on dietary and physical activity</measure>
    <time_frame>Baseline, 1-year post-intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Tailored intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription.&#xD;
Then, next monitoring circle was followed. In total, 7 monitoring round were completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Happy 10 exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition education group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receive no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monitoring and Tailored prescription</intervention_name>
    <arm_group_label>Tailored intervention group</arm_group_label>
    <other_name>ZhiJi accelerometer UX-02 as physical activity monitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Happy 10 program</intervention_name>
    <arm_group_label>Happy 10 exercise group</arm_group_label>
    <other_name>happy 10 program developed by Center for Disease Control and Prevention, China</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Specified nutrition education</intervention_name>
    <arm_group_label>Nutrition education group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General Health Education</intervention_name>
    <arm_group_label>Happy 10 exercise group</arm_group_label>
    <arm_group_label>Nutrition education group</arm_group_label>
    <arm_group_label>Tailored intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight and obese children from grade 1-5 primary schools&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students with any contraindication or physical diseases (heart, Lung, liver, kidney,&#xD;
             other vital organs, endocrine diseases and drug side effects et al.) and psychological&#xD;
             illnesses that may prevent them from participating in physical activity and eating a&#xD;
             normal diet were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Insitute of Child and Adolescent Health, Peking University</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 27, 2014</last_update_submitted>
  <last_update_submitted_qc>August 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Wang Jingjing</investigator_full_name>
    <investigator_title>Institute of Child and Adolescent Health</investigator_title>
  </responsible_party>
  <keyword>Childhood obesity, intervention, effectiveness, comparison</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/NCT02228434
org study id: IRB00001052-10081
nct id: NCT02228434
lead sponsor: 
The project aims at developing the tailored intervention strategy of childhood obesity based
      on monitoring physical activities with accelerometer and dietary behaviors using diary. It
      probably raise the passion of obese children to control weight, form healthy life style, be
      effective in sustaining weight loss and early prevent adulthood diseases.
The overweight and obese primary school students from 1-5 grades will be recruited according
      to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age
      Children". The participants with will be allocated with schools as the unit to four groups:
      tailored intervention based on monitoring physical activity and dietary behaviors, exercise
      intervention group based on the Happy 10 program, nutrition education intervention group. The
      three intervention groups received the designed interventions for the duration of 1 year.
      Before and after the intervention, we will carry out a questionnaire survey, a physical
      measurement, a fitness test, and a metabolic markers detection
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Change in body mass index
time frame: Baseline, 1-year post-intervention
measure: Change in obesity-related anthropometric measurements
time frame: Baseline, 1-year post-intervention
measure: Change of blood pressure
time frame: Baseline, 1-year post-intervention
measure: Change of biomarkers for disease risk
time frame: Baseline, 1-year post-intervention
measure: Change of attitude, knowledge, and behaviors on dietary and physical activity
time frame: Baseline, 1-year post-intervention
arm group label: Tailored intervention group
arm group type: Experimental
description: For the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription.
Then, next monitoring circle was followed. In total, 7 monitoring round were completed.
arm group label: Happy 10 exercise group
arm group type: Experimental
description: All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.
arm group label: Nutrition education group
arm group type: Experimental
description: The nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min.
arm group label: Control group
arm group type: No Intervention
description: Receive no intervention
intervention type: Behavioral
intervention name: Monitoring and Tailored prescription
arm group label: Tailored intervention group
other name: ZhiJi accelerometer UX-02 as physical activity monitor
intervention type: Behavioral
intervention name: Happy 10 program
arm group label: Happy 10 exercise group
other name: happy 10 program developed by Center for Disease Control and Prevention, China
intervention type: Behavioral
intervention name: Specified nutrition education
arm group label: Nutrition education group
intervention type: Behavioral
intervention name: General Health Education
arm group label: Happy 10 exercise group
arm group label: Nutrition education group
arm group label: Tailored intervention group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University
investigator full name: Wang Jingjing
investigator title: Institute of Child and Adolescent Health
mesh term: Obesity
mesh term: Pediatric Obesity