<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/NCT02212873</url>
  </required_header>
  <id_info>
    <org_study_id>NMRR1343916563</org_study_id>
    <nct_id>NCT02212873</nct_id>
  </id_info>
  <brief_title>My Body is Fit and Fabulous at School</brief_title>
  <acronym>MyBFF@school</acronym>
  <official_title>School-based Intervention Program - My Body is Fit and Fabulous</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Health, Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to address and curb the high prevalence of childhood obesity in Malaysia, a&#xD;
      school-based intervention program, MyBFF@school is developed for implementation in all&#xD;
      schools in the country. The program is specific for overweight and obese students and it is&#xD;
      hypothesized that by participating in this program, students will be able to control their&#xD;
      body mass index.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A nationwide Nutrition Survey of Malaysian Children carried out between 2008-2009 among 3542&#xD;
      children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8%&#xD;
      obesity while in a more recent 2011 Global School-based Student Heath Survey showed that the&#xD;
      percentage of overweight and obese Malaysian school children age 13-15 years old was 25.4%&#xD;
      and 10.9% respectively . If left unchecked, these children will grow up to be obese adults,&#xD;
      developed various obesity-related complications such as cardiovascular diseases, diabetes&#xD;
      etc. Realising the urgent needs to address the problems, the Ministry of Health Malaysia with&#xD;
      the cooperation of the Ministry of Education, proposed to implement MyBFF@school in all&#xD;
      schools in Malaysia. Students participating in MyBFF@school will take part in a structured&#xD;
      physical activity in the form of small sided football game (SSG), and are to attend&#xD;
      intensified and interactive nutrition and psychology classes aimed at improving their&#xD;
      knowledge, self-esteem and self-empowerment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI z-score</measure>
    <time_frame>32 weeks of intervention</time_frame>
    <description>The primary outcome is reduction in the BMI z-score of participating students.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage body fat</measure>
    <time_frame>32 weeks of intervention</time_frame>
    <description>Body fat of all participating students will be measured at baseline, week-16 and week-32 following intervention using Inbody 720 body composition analyzer (GE Healthcare).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">332</enrollment>
  <condition>Overweight</condition>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Equal number of age-matched overweight and obese students will be selected from a control school. There will be no intervention, and students will participate in their usual health and physical education classes plus any other curriculum activities provided by the school.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MyBFF@school program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students will participate in all 3 components of MyFF@school for a total of 32 weeks; 1-hour of SSG thrice weekly plus 30 to 45 minutes of either nutrition or psychology classes once a week. All students including those in the control arm will be assessed at baseline, week-16 and at end of the study. They will undergo anthropometric measurements, body fat assessment, clinical examination and fitness test by modified Harvard step-test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MyBFF@school program</intervention_name>
    <description>Students will be required to participate in all 3 components of MyBFF@school (SSG, nutrition and psychology sessions) for 16 weeks under the supervision of trained researchers, then for another 16 weeks supervised by their respective teachers-in-charge of physical education and/or co-curriculum activity. Each SSG session will be for an hour, thrice weekly while the nutrition or psychology session will be for 30-45 minutes once a week.</description>
    <arm_group_label>MyBFF@school program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Classified as overweight and obese based on BMI of 85th percentile and above, according to&#xD;
        WHO growth chart.&#xD;
&#xD;
        No medical conditions that could endanger their health when participating in MyBFF@school.&#xD;
&#xD;
        Obtained parental and assent consents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        With either physical or mental disability. With medical condition that prevents him/her to&#xD;
        participate in moderate-to-vigorous intensity physical activity.&#xD;
&#xD;
        With comorbidities that may interfere with the study such as diagnosed type 2 diabetes&#xD;
        mellitus, hypertension, nephritic syndrome, epilepsy, congenital heart disease and skeletal&#xD;
        anomalies.&#xD;
&#xD;
        On steroids, on anti-epileptics and on methylphenidate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wan Nazaimoon Wan Mohamud, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Medical Research, Ministry of Health Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)</name>
      <address>
        <city>Putrajaya</city>
        <state>Wilayah Persekutuan</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health, Malaysia</investigator_affiliation>
    <investigator_full_name>Wan Nazaimoon WM</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>school based intervention</keyword>
  <keyword>overweight</keyword>
  <keyword>obese</keyword>
  <keyword>BMI z score</keyword>
  <keyword>fat mass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02212873
org study id: NMRR1343916563
nct id: NCT02212873
lead sponsor: 
has dmc: Yes
In order to address and curb the high prevalence of childhood obesity in Malaysia, a
      school-based intervention program, MyBFF@school is developed for implementation in all
      schools in the country. The program is specific for overweight and obese students and it is
      hypothesized that by participating in this program, students will be able to control their
      body mass index.
A nationwide Nutrition Survey of Malaysian Children carried out between 2008-2009 among 3542
      children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8%
      obesity while in a more recent 2011 Global School-based Student Heath Survey showed that the
      percentage of overweight and obese Malaysian school children age 13-15 years old was 25.4%
      and 10.9% respectively . If left unchecked, these children will grow up to be obese adults,
      developed various obesity-related complications such as cardiovascular diseases, diabetes
      etc. Realising the urgent needs to address the problems, the Ministry of Health Malaysia with
      the cooperation of the Ministry of Education, proposed to implement MyBFF@school in all
      schools in Malaysia. Students participating in MyBFF@school will take part in a structured
      physical activity in the form of small sided football game (SSG), and are to attend
      intensified and interactive nutrition and psychology classes aimed at improving their
      knowledge, self-esteem and self-empowerment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMI z-score
time frame: 32 weeks of intervention
description: The primary outcome is reduction in the BMI z-score of participating students.
measure: Percentage body fat
time frame: 32 weeks of intervention
description: Body fat of all participating students will be measured at baseline, week-16 and week-32 following intervention using Inbody 720 body composition analyzer (GE Healthcare).
arm group label: Control
arm group type: No Intervention
description: Equal number of age-matched overweight and obese students will be selected from a control school. There will be no intervention, and students will participate in their usual health and physical education classes plus any other curriculum activities provided by the school.
arm group label: MyBFF@school program
arm group type: Experimental
description: Students will participate in all 3 components of MyFF@school for a total of 32 weeks; 1-hour of SSG thrice weekly plus 30 to 45 minutes of either nutrition or psychology classes once a week. All students including those in the control arm will be assessed at baseline, week-16 and at end of the study. They will undergo anthropometric measurements, body fat assessment, clinical examination and fitness test by modified Harvard step-test.
intervention type: Other
intervention name: MyBFF@school program
description: Students will be required to participate in all 3 components of MyBFF@school (SSG, nutrition and psychology sessions) for 16 weeks under the supervision of trained researchers, then for another 16 weeks supervised by their respective teachers-in-charge of physical education and/or co-curriculum activity. Each SSG session will be for an hour, thrice weekly while the nutrition or psychology session will be for 30-45 minutes once a week.
arm group label: MyBFF@school program
criteria: 
gender: All
minimum age: 7 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wan Nazaimoon Wan Mohamud, PhD
role: Principal Investigator
affiliation: Institute for Medical Research, Ministry of Health Malaysia
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health, Malaysia
investigator full name: Wan Nazaimoon WM
investigator title: Dr
mesh term: Overweight