<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/NCT04463069</url>
  </required_header>
  <id_info>
    <org_study_id>30160054</org_study_id>
    <nct_id>NCT04463069</nct_id>
  </id_info>
  <brief_title>School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong</brief_title>
  <official_title>School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Baptist University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hong Kong Baptist University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Considering that children with intellectual disability (ID) might be more vulnerable to&#xD;
      obesity than their counterparts in the general population. This study aimed to develop and&#xD;
      evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight&#xD;
      among adolescents with ID. The hypothesis of the study was the APA program would be able to&#xD;
      decrease obesity among adolescents with ID.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Children with intellectual disability (ID) might be more vulnerable to obesity&#xD;
      than their counterparts in the general population. This study aimed to evaluate the&#xD;
      effectiveness of an adapted physical activity (APA) program in reducing weight among&#xD;
      adolescents with ID.&#xD;
&#xD;
      Methods: A 9-month randomized controlled trial of a school-based APA program was conducted in&#xD;
      adolescents with ID and overweight/obesity in Hong Kong. The intervention group received the&#xD;
      APA program which consisted of endurance and strength-building exercises at a frequency of&#xD;
      two sessions per week, while the control group received routine PE classes as usual. Data on&#xD;
      obesity-related variables were collected before the intervention, at the midpoint of the&#xD;
      intervention and after the intervention. Linear mixed-effect models were used to examine the&#xD;
      intervention effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMIz Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Body Fat Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-to-height Ratio Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>Waist-to-height ratio was calculated by dividing the waist circumference by the height.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory Fitness Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>Cardiorespiratory fitness was assessed using the 9-minute run/walk test. The test measured how far a person can cover a flat surface 25 meters in length over a 9-minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular Strength and Endurance Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>The muscular strength and endurance were measured by handgrip strength and sit-ups. The handgrip strength was measured using a dynamometer (Takei, TKK5001, GRIP-A digital dynamometer). The sit-ups measured the total number of correctly completed sit-ups performed in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility Change</measure>
    <time_frame>Change from baseline at 4 months and 9 months</time_frame>
    <description>Flexibility was measured by the sit-and-reach test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group received no intervention in the study time period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adapted physical activity</intervention_name>
    <description>This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 12 and 18 years&#xD;
&#xD;
          -  overweight and obesity&#xD;
&#xD;
          -  mild or moderate intellectual disability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical disability&#xD;
&#xD;
          -  medical predispositions towards obesity (genetic syndrome or drug treatment)&#xD;
&#xD;
          -  contraindications (e.g. asthma, heart disease)&#xD;
&#xD;
          -  having participated in other exercise programs in the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Gao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Baptist University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong Kong Bapist University</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <results_first_submitted>November 10, 2020</results_first_submitted>
  <results_first_submitted_qc>July 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2021</results_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Baptist University</investigator_affiliation>
    <investigator_full_name>Gao Yang</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>adolescents</keyword>
  <keyword>intellectual disability</keyword>
  <keyword>overweight</keyword>
  <keyword>obesity</keyword>
  <keyword>physical activity</keyword>
  <keyword>intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04463069/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04463069/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Initially, 81 eligible students with parental informed consent were recruited (41 in intervention and 40 in control). 13 in control withdrew after learning the assignment results. 5 more were then recruited into the control to fulfill sample size (32). After commencement of study, 2 and 10 withdrew from intervention and control respectively. Finally, 61 (39 in intervention and 22 in control) completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Participants in the control group received no intervention in the study time period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participants' parents refused to participate after learning the assignment results</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis was performed on subjects who completed the entire study.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Participants in the control group received no intervention in the study time period.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>BMI Change</title>
        <description>The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants in the control group received no intervention in the study time period.</description>
          </group>
        </group_list>
        <measure>
          <title>BMI Change</title>
          <description>The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.</description>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean change from baseline to 4 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" lower_limit="-0.44" upper_limit="0.16"/>
                    <measurement group_id="O2" value="0.42" lower_limit="0.12" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean change from baseline to 9 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" lower_limit="-1.06" upper_limit="-0.25"/>
                    <measurement group_id="O2" value="0.68" lower_limit="0.16" upper_limit="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMIz Change</title>
        <description>The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants in the control group received no intervention in the study time period.</description>
          </group>
        </group_list>
        <measure>
          <title>BMIz Change</title>
          <description>The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.</description>
          <units>z-score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean change from baseline to 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" lower_limit="-0.12" upper_limit="-0.00"/>
                    <measurement group_id="O2" value="0.07" lower_limit="-0.00" upper_limit="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean change from baseline to 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" lower_limit="-0.32" upper_limit="-0.14"/>
                    <measurement group_id="O2" value="0.10" lower_limit="-0.03" upper_limit="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Change</title>
        <description>Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants in the control group received no intervention in the study time period.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change</title>
          <description>Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean change from baseline to 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" lower_limit="-0.28" upper_limit="1.12"/>
                    <measurement group_id="O2" value="1.79" lower_limit="0.90" upper_limit="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean change from baseline to 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" lower_limit="-1.06" upper_limit="0.75"/>
                    <measurement group_id="O2" value="2.76" lower_limit="1.45" upper_limit="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Body Fat Change</title>
        <description>Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants in the control group received no intervention in the study time period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Body Fat Change</title>
          <description>Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean change from baseline to 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" lower_limit="-1.18" upper_limit="0.80"/>
                    <measurement group_id="O2" value="0.80" lower_limit="-0.24" upper_limit="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean change from baseline to 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.46" lower_limit="-2.41" upper_limit="-0.52"/>
                    <measurement group_id="O2" value="0.24" lower_limit="-0.60" upper_limit="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Waist Circumference Change</title>
        <description>Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants in the control group received no intervention in the study time period.</description>
          </group>
        </group_list>
        <measure>
          <title>Waist Circumference Change</title>
          <description>Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean change from baseline to 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.66" lower_limit="-3.02" upper_limit="-0.29"/>
                    <measurement group_id="O2" value="1.50" lower_limit="-0.01" upper_limit="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean change from baseline to 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" lower_limit="-3.80" upper_limit="-0.23"/>
                    <measurement group_id="O2" value="1.76" lower_limit="-0.25" upper_limit="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Waist-to-height Ratio Change</title>
        <description>Waist-to-height ratio was calculated by dividing the waist circumference by the height.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants in the control group received no intervention in the study time period.</description>
          </group>
        </group_list>
        <measure>
          <title>Waist-to-height Ratio Change</title>
          <description>Waist-to-height ratio was calculated by dividing the waist circumference by the height.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean change from baseline to 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" lower_limit="-0.02" upper_limit="-0.00"/>
                    <measurement group_id="O2" value="0.01" lower_limit="-0.00" upper_limit="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean change from baseline to 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" lower_limit="-0.03" upper_limit="-0.01"/>
                    <measurement group_id="O2" value="0.01" lower_limit="-0.01" upper_limit="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiorespiratory Fitness Change</title>
        <description>Cardiorespiratory fitness was assessed using the 9-minute run/walk test. The test measured how far a person can cover a flat surface 25 meters in length over a 9-minute period.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Muscular Strength and Endurance Change</title>
        <description>The muscular strength and endurance were measured by handgrip strength and sit-ups. The handgrip strength was measured using a dynamometer (Takei, TKK5001, GRIP-A digital dynamometer). The sit-ups measured the total number of correctly completed sit-ups performed in 30 seconds.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Flexibility Change</title>
        <description>Flexibility was measured by the sit-and-reach test.</description>
        <time_frame>Change from baseline at 4 months and 9 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months</time_frame>
      <desc>Possible adverse effects (e.g., sports injury, underweight, binge eating) suggested by previous studies will be prevented via diverse means (e.g., to inform children and parents of the possible adverse consequences in advance and provide feasible and practical preventive strategies to them). They can reach the research team via a hotline on an ad hoc basis. The adverse events will be monitored among participants who completed the baseline assessments.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.&#xD;
Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Participants in the control group received no intervention in the study time period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Yang Gao</name_or_title>
      <organization>Hong Kong Baptist University</organization>
      <phone>+852 3411 3082</phone>
      <email>gaoyang@hkbu.edu.hk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04463069
org study id: 30160054
nct id: NCT04463069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Considering that children with intellectual disability (ID) might be more vulnerable to
      obesity than their counterparts in the general population. This study aimed to develop and
      evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight
      among adolescents with ID. The hypothesis of the study was the APA program would be able to
      decrease obesity among adolescents with ID.
Background: Children with intellectual disability (ID) might be more vulnerable to obesity
      than their counterparts in the general population. This study aimed to evaluate the
      effectiveness of an adapted physical activity (APA) program in reducing weight among
      adolescents with ID.

      Methods: A 9-month randomized controlled trial of a school-based APA program was conducted in
      adolescents with ID and overweight/obesity in Hong Kong. The intervention group received the
      APA program which consisted of endurance and strength-building exercises at a frequency of
      two sessions per week, while the control group received routine PE classes as usual. Data on
      obesity-related variables were collected before the intervention, at the midpoint of the
      intervention and after the intervention. Linear mixed-effect models were used to examine the
      intervention effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: BMI Change
time frame: Change from baseline at 4 months and 9 months
description: The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.
measure: BMIz Change
time frame: Change from baseline at 4 months and 9 months
description: The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.
measure: Weight Change
time frame: Change from baseline at 4 months and 9 months
description: Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.
measure: Percent Body Fat Change
time frame: Change from baseline at 4 months and 9 months
description: Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.
measure: Waist Circumference Change
time frame: Change from baseline at 4 months and 9 months
description: Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration
measure: Waist-to-height Ratio Change
time frame: Change from baseline at 4 months and 9 months
description: Waist-to-height ratio was calculated by dividing the waist circumference by the height.
measure: Cardiorespiratory Fitness Change
time frame: Change from baseline at 4 months and 9 months
description: Cardiorespiratory fitness was assessed using the 9-minute run/walk test. The test measured how far a person can cover a flat surface 25 meters in length over a 9-minute period.
measure: Muscular Strength and Endurance Change
time frame: Change from baseline at 4 months and 9 months
description: The muscular strength and endurance were measured by handgrip strength and sit-ups. The handgrip strength was measured using a dynamometer (Takei, TKK5001, GRIP-A digital dynamometer). The sit-ups measured the total number of correctly completed sit-ups performed in 30 seconds.
measure: Flexibility Change
time frame: Change from baseline at 4 months and 9 months
description: Flexibility was measured by the sit-and-reach test.
arm group label: intervention group
arm group type: Experimental
description: Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.
arm group label: control group
arm group type: No Intervention
description: Participants in the control group received no intervention in the study time period.
intervention type: Other
intervention name: Adapted physical activity
description: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.
arm group label: intervention group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yang Gao, PhD
role: Principal Investigator
affiliation: Hong Kong Baptist University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Baptist University
investigator full name: Gao Yang
investigator title: Assistant Professor
mesh term: Intellectual Disability
mesh term: Obesity
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 