<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/NCT04431115</url>
  </required_header>
  <id_info>
    <org_study_id>OjedoyinO</org_study_id>
    <nct_id>NCT04431115</nct_id>
  </id_info>
  <brief_title>Physical Activity, Sedentary Behaviour and Physical Fitness Profile of Primary School Children in Lagos, Nigeria.</brief_title>
  <official_title>Levels, Patterns and Correlates of Physical Activity, Sedentary Behaviour and Physical Fitness Profile of Primary School Children in Lagos, Nigeria; Development of a Physical Activity Guideline.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of KwaZulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of KwaZulu</source>
  <brief_summary>
    <textblock>
      This research study intends to use a mixed method approach(both qualitative and quantitative)&#xD;
      to describe and analyse the levels, patterns, and correlates of physical activity((PA),&#xD;
      sedentary behaviour(SB), and physical fitness(PF) profiles of primary school children in&#xD;
      Lagos state, Nigeria. The study is in four phases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase1 is a scoping review of literature of the level of compliance of all the countries in&#xD;
      sub-saharan Africa to the Global observatory on physical activity(GOPA) recommendation on the&#xD;
      minimum level of daily physical activity to reduce incidence of non communicable chronic&#xD;
      diseases e.g. hypertension, diabetes, obesity etc.&#xD;
&#xD;
      Phase2 is a concurrent mixed method which will explore parents and other stakeholders&#xD;
      awareness, understanding and perspectives on PA,SB, and PF among primary school children in&#xD;
      Lagos, Nigeria.&#xD;
&#xD;
      Phase 3 is a cross sectional study which will investigate levels, patterns and correlates&#xD;
      among physical activity, sedentary behaviour and physical fitness profile of primary school&#xD;
      children in Lagos, Nigeria.&#xD;
&#xD;
      Phase 4 is development of physical activity guideline for primary school children in Lagos,&#xD;
      Nigeria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Youth activity profile(YAP)</measure>
    <time_frame>About 5 days</time_frame>
    <description>It is a self reported questionnaire. It is a physical activity assessment tool designed to assess children and adolescents' physical activity. it is for children between 10-12 years. Three indices are being measured from YAP. These are physical activity at school index(PASI), Physical activity at home index(PAHI) and Sedentary behaviour index(SBI).It consists of 15 total items each scored on a 5- point scale. A higher overall activity score is reflective of a higher level of physical activity(or a greater amount of sedentary behaviour in the case of the SBI. It is on a 5 point scale with 1 being the minimum and 5 maximum to assess physical activity at school.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children physical activity questionnaire(CPAQ)</measure>
    <time_frame>for activities over the past seven days.</time_frame>
    <description>It assess mode, frequency and duration of physical activity and sedentary activities. The no of activities run from 1 to 5. 1 being the minimum while 5 is maximum no of days. throughout all domains over the past 7 days. The more the activities participated in each domain the higher the level of physical activity and the lower the sedentary behaviour.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1038</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Stakeholders</arm_group_label>
    <description>Academic experts, Politicians and officials of state ministries of health and education and teachers.&#xD;
Interviews will be conducted for academic experts, politicians and officials of state ministries of health and education.&#xD;
Headteachers and physical education teachers will be administered questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents</arm_group_label>
    <description>Parents of the primary school children to be recruited for the study. Focus group discussion in a group of 3 of ten in each group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary school children aged 6-12 yrs.</arm_group_label>
    <description>A cross sectional survey of the biographical data, socio economic status, physical activity level through appropriate questionnaires will be done.&#xD;
A pedometer will be attached to the waist of each of the participants for a consecutive 7 days to objectively determine the level of their physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews</intervention_name>
    <description>Interviews for stakeholders</description>
    <arm_group_label>Parents</arm_group_label>
    <arm_group_label>Primary school children aged 6-12 yrs.</arm_group_label>
    <arm_group_label>Stakeholders</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population are primary school children(6-12 yrs) in public and private schools in&#xD;
        Lagos state, Nigeria..&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: 1.Must be Primary school children between ages 6 and 12 years in Lagos,&#xD;
        Nigeria.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Obvious lower limb musculoskeletal diseases.&#xD;
&#xD;
          2. Normal gait impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olusegun O Ojedoyin</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKZN</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pragashnie Govender</last_name>
    <role>Study Chair</role>
    <affiliation>UKZN</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thayananthee Nadasan</last_name>
    <role>Study Director</role>
    <affiliation>UKZN</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael O Olagbegi</last_name>
    <role>Study Director</role>
    <affiliation>UKZN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lagos state primary schools</name>
      <address>
        <city>Lagos</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of KwaZulu</investigator_affiliation>
    <investigator_full_name>Olusegun O. Ojedoyin</investigator_full_name>
    <investigator_title>PhD candidate, School of health sciences, University of Kwazulu-Natal</investigator_title>
  </responsible_party>
  <!-- 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/NCT04431115
org study id: OjedoyinO
nct id: NCT04431115
lead sponsor: 
This research study intends to use a mixed method approach(both qualitative and quantitative)
      to describe and analyse the levels, patterns, and correlates of physical activity((PA),
      sedentary behaviour(SB), and physical fitness(PF) profiles of primary school children in
      Lagos state, Nigeria. The study is in four phases.
Phase1 is a scoping review of literature of the level of compliance of all the countries in
      sub-saharan Africa to the Global observatory on physical activity(GOPA) recommendation on the
      minimum level of daily physical activity to reduce incidence of non communicable chronic
      diseases e.g. hypertension, diabetes, obesity etc.

      Phase2 is a concurrent mixed method which will explore parents and other stakeholders
      awareness, understanding and perspectives on PA,SB, and PF among primary school children in
      Lagos, Nigeria.

      Phase 3 is a cross sectional study which will investigate levels, patterns and correlates
      among physical activity, sedentary behaviour and physical fitness profile of primary school
      children in Lagos, Nigeria.

      Phase 4 is development of physical activity guideline for primary school children in Lagos,
      Nigeria.
observational model: Other
time perspective: Cross-Sectional
measure: Youth activity profile(YAP)
time frame: About 5 days
description: It is a self reported questionnaire. It is a physical activity assessment tool designed to assess children and adolescents' physical activity. it is for children between 10-12 years. Three indices are being measured from YAP. These are physical activity at school index(PASI), Physical activity at home index(PAHI) and Sedentary behaviour index(SBI).It consists of 15 total items each scored on a 5- point scale. A higher overall activity score is reflective of a higher level of physical activity(or a greater amount of sedentary behaviour in the case of the SBI. It is on a 5 point scale with 1 being the minimum and 5 maximum to assess physical activity at school.
measure: Children physical activity questionnaire(CPAQ)
time frame: for activities over the past seven days.
description: It assess mode, frequency and duration of physical activity and sedentary activities. The no of activities run from 1 to 5. 1 being the minimum while 5 is maximum no of days. throughout all domains over the past 7 days. The more the activities participated in each domain the higher the level of physical activity and the lower the sedentary behaviour.
arm group label: Stakeholders
description: Academic experts, Politicians and officials of state ministries of health and education and teachers.
Interviews will be conducted for academic experts, politicians and officials of state ministries of health and education.
Headteachers and physical education teachers will be administered questionnaires.
arm group label: Parents
description: Parents of the primary school children to be recruited for the study. Focus group discussion in a group of 3 of ten in each group.
arm group label: Primary school children aged 6-12 yrs.
description: A cross sectional survey of the biographical data, socio economic status, physical activity level through appropriate questionnaires will be done.
A pedometer will be attached to the waist of each of the participants for a consecutive 7 days to objectively determine the level of their physical activity.
intervention type: Other
intervention name: Interviews
description: Interviews for stakeholders
arm group label: Parents
arm group label: Primary school children aged 6-12 yrs.
arm group label: Stakeholders
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olusegun O Ojedoyin
role: Principal Investigator
affiliation: UKZN
last name: Pragashnie Govender
role: Study Chair
affiliation: UKZN
last name: Thayananthee Nadasan
role: Study Director
affiliation: UKZN
last name: Michael O Olagbegi
role: Study Director
affiliation: UKZN
facility: 
country: Nigeria
responsible party type: Principal Investigator
investigator affiliation: University of KwaZulu
investigator full name: Olusegun O. Ojedoyin
investigator title: PhD candidate, School of health sciences, University of Kwazulu-Natal