<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/NCT04487132</url>
  </required_header>
  <id_info>
    <org_study_id>FJWU/Reg/2020</org_study_id>
    <nct_id>NCT04487132</nct_id>
  </id_info>
  <brief_title>Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents</brief_title>
  <official_title>Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatima Jinnah Women University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fatima Jinnah Women 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>
      This study examines the effect of self designed school-based interventions on physical&#xD;
      activity and psychological outcomes (i.e., internalizing and externalizing behavioral&#xD;
      symptoms, self-concept, and academic achievement among a community sample of adolescents from&#xD;
      Taxila, Pakistan&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study is to assess the level of motivation towards physical&#xD;
      activity and psychosocial outcomes (i.e., internalizing and externalizing behavioral&#xD;
      symptoms, self-concept and academic achievement as assessed through recent grade) among young&#xD;
      adolescents and to develop intervention to enhance motivation towards physical activity among&#xD;
      young adolescents. Randomized Control Trial design will be used in this study to examine the&#xD;
      impact of school-based intervention on motivation towards physical activity and psychosocial&#xD;
      outcomes. After assessing their motivation toward physical activity and psychosocial outcomes&#xD;
      intervention will given for 10 weeks, in which participants will be asked to participate in&#xD;
      10 minutes exercise activity on regular basis from Monday to Friday during school timings.&#xD;
      Assessment will be done to find out that whether the school based intervention will be&#xD;
      effective for them in motivation towards physical activity and reduction psychosocial&#xD;
      outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and&#xD;
      academic achievement (as assessed through recent grade)) among adolescents or not. This&#xD;
      results of this study will be used in promoting active lifestyle may help the adolescent to&#xD;
      develop long-term positive healthy habits and targeting adolescents through encouraging&#xD;
      physical activity in school or educational setting and social surrounding. To make decision&#xD;
      about effective programs and policies to promote physical activity should be taken in&#xD;
      account, by providing empirical support for public health messages that encourage&#xD;
      participation in school spots as a mean to reduce the burden of poor mental health. Physical&#xD;
      activity programming must align with the predictable developmental changes in adolescent&#xD;
      exercise capacity and motor skills, which affect the activities in which they can&#xD;
      successfully engage. These programs specifically designed to improve psychosocial outcomes,&#xD;
      such as self-concept, social behavior and self-efficacy of adolescents as these are the most&#xD;
      important determinants of participation in physical activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2020</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>
    <intervention_model_description>Randomized control trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes among adolescents. In trials with randomized and controlled design the effects of the study (school based intervention and psychosocial outcomes) are compared with those of a control group and the participants are randomly assigned to the two groups. In this interventional model Active physical education lessons and physical education plan will be carried out which includes, Physical activities 10 -15 minutes daily or at least 5 days in a week during the school timings.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motivation towards Physical Activity</measure>
    <time_frame>1 month</time_frame>
    <description>the level of motivation towards physical activity will be assessed by the Participation Motivation Questionnaire.Participation Motivation Questionnaire is 3 point likert scale 1 for very important and 3 for not at all important.The Participation Motivation Questionnaire will revealed the factors of achievement/status, team atmosphere, fitness, energy release, skill development, friend- ship and fun as basic motives for involvement .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of Physical Activity</measure>
    <time_frame>1 month</time_frame>
    <description>The Level of Physical Activity will be assessed through through using the physical activity questionnaire- adolescents (PAQ-A) is a self-administered, 7-day recall instrument , each scored on a 5-point scale. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial Outcomes</measure>
    <time_frame>1 month</time_frame>
    <description>Psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms) will be assessed through Adolescents Behavioural Checklist is four point likert scale where o for Not at all and 3 for very much. Adolescents Behavioural Checklist consists of 48 items, 42 of which yield a total ABC score and six factor scores (Conduct Problems, Impulsivity/Hyperactivity, Poor Work Habits, Inattention, Emotional Liability, Social Problems).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self Concept</measure>
    <time_frame>1 month</time_frame>
    <description>Self-Concept will be assessed through using Self Concept Questionnaire .t consist of 48 items which provides 6 separate dimensions of self-concept (e.g physical, social, intellectual, moral, educational and temperamental) ,each item have 5 response.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Academic Achievement</measure>
    <time_frame>1 month</time_frame>
    <description>Academic Achievement will be assess through recent academic achievement or performance in exams</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>School Based Intervention</condition>
  <arm_group>
    <arm_group_label>Active physical education lessons and physical education plan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active physical education lessons and physical education plan provided to the controlled group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recess or lunch time activities</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preparing the playground by offering adequate spaces and games provided to the experimental group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active physical education lessons and physical education plan</intervention_name>
    <description>Active physical education lessons and physical education plan Including importance of physical activity and health, and physical education plan; through lecture in classroom will be provided to the contyrolled group.</description>
    <arm_group_label>Active physical education lessons and physical education plan</arm_group_label>
    <arm_group_label>Recess or lunch time activities</arm_group_label>
    <other_name>physical education plan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recess or lunch time activities</intervention_name>
    <description>group intervention will be provided ti the experimental group which includes Preparing the playground by offering adequate spaces and games.Developing games and teaching children to play in recess time at-least 10-15 minutes daily(i.e.sport games, traditional games) Placing a sheet in the classroom with some reminders about being active in recess time (i.e. using a poster board encouraging playing one of the selected games )</description>
    <arm_group_label>Recess or lunch time activities</arm_group_label>
    <other_name>physical activities group intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants from grade 6th to 8th with in age range of 10-15 years.&#xD;
&#xD;
          -  Participants who have lack of physical activity.&#xD;
&#xD;
          -  Participants who provide consent to take part in the intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those participants who do not provide consent to take part in intervention will not be&#xD;
             eligible take part in intervention.&#xD;
&#xD;
          -  Participants who are having any physical disability or medical condition that&#xD;
             compromises their mobility will not take part in intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fatima Jinnah Women University Ethics Review Board</name>
      <address>
        <city>Rawalpindi</city>
        <state>Punjab</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sajida Naz, Dr</last_name>
      <phone>0332-9370378</phone>
      <email>dr.sajida@fjwu.edu.pk</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fatima Jinnah Women University</investigator_affiliation>
    <investigator_full_name>Anmol Ayaz</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <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/NCT04487132
org study id: FJWU/Reg/2020
nct id: NCT04487132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the effect of self designed school-based interventions on physical
      activity and psychological outcomes (i.e., internalizing and externalizing behavioral
      symptoms, self-concept, and academic achievement among a community sample of adolescents from
      Taxila, Pakistan
The main objective of this study is to assess the level of motivation towards physical
      activity and psychosocial outcomes (i.e., internalizing and externalizing behavioral
      symptoms, self-concept and academic achievement as assessed through recent grade) among young
      adolescents and to develop intervention to enhance motivation towards physical activity among
      young adolescents. Randomized Control Trial design will be used in this study to examine the
      impact of school-based intervention on motivation towards physical activity and psychosocial
      outcomes. After assessing their motivation toward physical activity and psychosocial outcomes
      intervention will given for 10 weeks, in which participants will be asked to participate in
      10 minutes exercise activity on regular basis from Monday to Friday during school timings.
      Assessment will be done to find out that whether the school based intervention will be
      effective for them in motivation towards physical activity and reduction psychosocial
      outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and
      academic achievement (as assessed through recent grade)) among adolescents or not. This
      results of this study will be used in promoting active lifestyle may help the adolescent to
      develop long-term positive healthy habits and targeting adolescents through encouraging
      physical activity in school or educational setting and social surrounding. To make decision
      about effective programs and policies to promote physical activity should be taken in
      account, by providing empirical support for public health messages that encourage
      participation in school spots as a mean to reduce the burden of poor mental health. Physical
      activity programming must align with the predictable developmental changes in adolescent
      exercise capacity and motor skills, which affect the activities in which they can
      successfully engage. These programs specifically designed to improve psychosocial outcomes,
      such as self-concept, social behavior and self-efficacy of adolescents as these are the most
      important determinants of participation in physical activities.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes among adolescents. In trials with randomized and controlled design the effects of the study (school based intervention and psychosocial outcomes) are compared with those of a control group and the participants are randomly assigned to the two groups. In this interventional model Active physical education lessons and physical education plan will be carried out which includes, Physical activities 10 -15 minutes daily or at least 5 days in a week during the school timings.
primary purpose: Prevention
masking: None (Open Label)
measure: Motivation towards Physical Activity
time frame: 1 month
description: the level of motivation towards physical activity will be assessed by the Participation Motivation Questionnaire.Participation Motivation Questionnaire is 3 point likert scale 1 for very important and 3 for not at all important.The Participation Motivation Questionnaire will revealed the factors of achievement/status, team atmosphere, fitness, energy release, skill development, friend- ship and fun as basic motives for involvement .
measure: Level of Physical Activity
time frame: 1 month
description: The Level of Physical Activity will be assessed through through using the physical activity questionnaire- adolescents (PAQ-A) is a self-administered, 7-day recall instrument , each scored on a 5-point scale. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
measure: Psychosocial Outcomes
time frame: 1 month
description: Psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms) will be assessed through Adolescents Behavioural Checklist is four point likert scale where o for Not at all and 3 for very much. Adolescents Behavioural Checklist consists of 48 items, 42 of which yield a total ABC score and six factor scores (Conduct Problems, Impulsivity/Hyperactivity, Poor Work Habits, Inattention, Emotional Liability, Social Problems).
measure: Self Concept
time frame: 1 month
description: Self-Concept will be assessed through using Self Concept Questionnaire .t consist of 48 items which provides 6 separate dimensions of self-concept (e.g physical, social, intellectual, moral, educational and temperamental) ,each item have 5 response.
measure: Academic Achievement
time frame: 1 month
description: Academic Achievement will be assess through recent academic achievement or performance in exams
arm group label: Active physical education lessons and physical education plan
arm group type: Active Comparator
description: Active physical education lessons and physical education plan provided to the controlled group
arm group label: Recess or lunch time activities
arm group type: Active Comparator
description: Preparing the playground by offering adequate spaces and games provided to the experimental group
intervention type: Behavioral
intervention name: Active physical education lessons and physical education plan
description: Active physical education lessons and physical education plan Including importance of physical activity and health, and physical education plan; through lecture in classroom will be provided to the contyrolled group.
arm group label: Active physical education lessons and physical education plan
arm group label: Recess or lunch time activities
other name: physical education plan
intervention type: Behavioral
intervention name: Recess or lunch time activities
description: group intervention will be provided ti the experimental group which includes Preparing the playground by offering adequate spaces and games.Developing games and teaching children to play in recess time at-least 10-15 minutes daily(i.e.sport games, traditional games) Placing a sheet in the classroom with some reminders about being active in recess time (i.e. using a poster board encouraging playing one of the selected games )
arm group label: Recess or lunch time activities
other name: physical activities group intervention
criteria: 
gender: All
minimum age: 10 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Fatima Jinnah Women University
investigator full name: Anmol Ayaz
investigator title: principle investigator
sharing ipd: No