<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/NCT03773250</url>
  </required_header>
  <id_info>
    <org_study_id>201603121RIND</org_study_id>
    <nct_id>NCT03773250</nct_id>
  </id_info>
  <brief_title>A FAMILY Program for Childhood Overweight and Obesity</brief_title>
  <official_title>A FAMILY Program for Childhood Overweight and Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Childhood overweight and obesity is a health problem with lifelong implications related to&#xD;
      diabetes, hypertension, cardiovascular disease, psychological disorders as well as other&#xD;
      chronic conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Taiwan, the nationwide prevalence of overweight and obesity among school-age children aged&#xD;
      7 to 11 years has also increased over the past years. Sleep and weight are intricately&#xD;
      related. School-age children requires at least 10 hours of sleep per night but children in&#xD;
      Asian countries are on average obtaining shorter sleep than children in Caucasian countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child BMI-for-age z-score</measure>
    <time_frame>Change from baseline to 12 months post intervention</time_frame>
    <description>Child BMI-for-age z-score will be computed based on the World Health Organization growth reference data for 5-19 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child BMI</measure>
    <time_frame>Change from baseline to 12 months post intervention</time_frame>
    <description>Child BMI will be calculated based on child weight and height.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child percent body fat</measure>
    <time_frame>Change from baseline to 12 months post intervention</time_frame>
    <description>Percent body fat will be estimated according to the skinfold thickness equations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child sleep duration and sleep efficiency</measure>
    <time_frame>Change from baseline to 12 months post intervention</time_frame>
    <description>Actigraphy-derived daily sleep duration and nocturnal sleep efficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental sleep quality</measure>
    <time_frame>Change from baseline to 12 months post intervention</time_frame>
    <description>Pittsburgh Sleep Quality Index total scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Behavioral Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children and families in the intervention group will received the FAMILY program developed according to evidence-based guidelines.The intervention content regarding healthy sleep will emphasize the importance of having a consistent sleep schedule, establishing a regular bedtime routine, and creating an environment only for sleeping. The physical activity content will emphasize at least 60 minutes/day of moderate-to-vigorous intensity physical activity, reduction of sedentary behavior, and screen time limited to 2 hours/day. The nutrition content will emphasis the replacement of sugar-sweetened beverages, increased fruit and vegetable as well as water intake, consumption of regular meals, and reduction of discretionary food groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral intervention</intervention_name>
    <description>The intervention has an intensive phase and a maintenance phase.</description>
    <arm_group_label>Behavioral Intervention</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with overweight and obesity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with any other chronic or acute medical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shao-Yu Tsai, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT03773250
org study id: 201603121RIND
nct id: NCT03773250
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Childhood overweight and obesity is a health problem with lifelong implications related to
      diabetes, hypertension, cardiovascular disease, psychological disorders as well as other
      chronic conditions.
In Taiwan, the nationwide prevalence of overweight and obesity among school-age children aged
      7 to 11 years has also increased over the past years. Sleep and weight are intricately
      related. School-age children requires at least 10 hours of sleep per night but children in
      Asian countries are on average obtaining shorter sleep than children in Caucasian countries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Child BMI-for-age z-score
time frame: Change from baseline to 12 months post intervention
description: Child BMI-for-age z-score will be computed based on the World Health Organization growth reference data for 5-19 years.
measure: Child BMI
time frame: Change from baseline to 12 months post intervention
description: Child BMI will be calculated based on child weight and height.
measure: Child percent body fat
time frame: Change from baseline to 12 months post intervention
description: Percent body fat will be estimated according to the skinfold thickness equations.
measure: child sleep duration and sleep efficiency
time frame: Change from baseline to 12 months post intervention
description: Actigraphy-derived daily sleep duration and nocturnal sleep efficiency
measure: Parental sleep quality
time frame: Change from baseline to 12 months post intervention
description: Pittsburgh Sleep Quality Index total scores
arm group label: Behavioral Intervention
arm group type: Experimental
description: Children and families in the intervention group will received the FAMILY program developed according to evidence-based guidelines.The intervention content regarding healthy sleep will emphasize the importance of having a consistent sleep schedule, establishing a regular bedtime routine, and creating an environment only for sleeping. The physical activity content will emphasize at least 60 minutes/day of moderate-to-vigorous intensity physical activity, reduction of sedentary behavior, and screen time limited to 2 hours/day. The nutrition content will emphasis the replacement of sugar-sweetened beverages, increased fruit and vegetable as well as water intake, consumption of regular meals, and reduction of discretionary food groups.
arm group label: Control
arm group type: Other
description: An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education.
intervention type: Behavioral
intervention name: Behavioral intervention
description: The intervention has an intensive phase and a maintenance phase.
arm group label: Behavioral Intervention
arm group label: Control
criteria: 
gender: All
minimum age: 6 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shao-Yu Tsai, PhD
role: Principal Investigator
affiliation: National Taiwan University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity
sharing ipd: No