<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/NCT03303287</url>
  </required_header>
  <id_info>
    <org_study_id>HEC_4553</org_study_id>
    <nct_id>NCT03303287</nct_id>
  </id_info>
  <brief_title>School Health Education Program in Pakistan(SHEPP)</brief_title>
  <acronym>SHEPP</acronym>
  <official_title>School Health Education Program in Pakistan(SHEPP) ; Impact on Lifestyle and Cardio-</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan 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>
      Pakistan is a developing country and there have been a considerable rise in obesity and&#xD;
      hypertension in children in recent years. In this setting a focus on primary prevention of&#xD;
      cardiovascular diseases is more cost effective than spending resources on secondary or&#xD;
      tertiary prevention,. Primary prevention includes interventions to promote physical activity&#xD;
      (&gt; 30 minutes/day in school), healthy dietary habits (decreased consumption of sweetened&#xD;
      beverages and snacks, and increased consumption of fruit and vegetables) and health education&#xD;
      focusing on cardiovascular risk factors in school children. This would translate into&#xD;
      healthier cardiovascular outcomes (eg. less hypertension, dyslipidemia and diabetes) in adult&#xD;
      life. The investigators propose a school health education program for Pakistan (SHEPP) for&#xD;
      children aged 9-11 years in 3 schools in Karachi for a period of one year. This program will&#xD;
      comprise of 140 minutes physical activity/week (including aerobics):30 minutes aerobic&#xD;
      PA(30*2=60) + 10 minutes (10*5=50)physical activity in assembly daily+ 1 minute between&#xD;
      periods(1*6*5=30) and healthy diet and healthy heart teaching. Additionally teaching will&#xD;
      also be given to teachers and parents, who will further reinforce these habits in children.&#xD;
      We hypothesise that SHEPP will improve physical activity levels, dietary habits and knowledge&#xD;
      about healthy heart in children, will decrease blood pressure, body mass index, waist&#xD;
      circumference, at the end of the year. If this healthy behavior is carried on to adult life&#xD;
      it will serve as an excellent primary prevention measure. The investigators , later on plan&#xD;
      to study long term outcomes after implementation of this intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1.1.Interventions to reduce childhood obesity School based programs have also been introduced&#xD;
      as interventions to assess the impact on blood pressure ant weight. In effectiveness trial&#xD;
      done by Yin et al on the impact of 8 months after school physical activity programme&#xD;
      demonstrated a reduction in percentage body fat, but no effect on blood pressure.(52) Schools&#xD;
      have been unable to provide sufficient time and resources for students to meet all the&#xD;
      objectives of standard physical education, the concept of &quot;health-related&#xD;
      PE&quot;.(13)Traditionally, the role of schools in providing and promoting physical activity has&#xD;
      been during the school day (eg, PE, recess) and/or on the school campus immediately after&#xD;
      school. Trial of Activity for Adolescent Girls (TAAG) is a large-scale randomized trial&#xD;
      involving 36 schools at 6 study sites across the United States and sponsored by the National&#xD;
      Heart, Lung, and Blood Institute. This large-scale study is examining the effects of a&#xD;
      school-community linked intervention on overall physical activity in middle school girls.(53)&#xD;
&#xD;
      Physical activity and behavior of change theory The effectiveness of physical activity&#xD;
      interventions would benefit from a better understanding of this behavior. (54) Theory of&#xD;
      planned behavior has demonstrated usefulness in studies of health-related behavior.(55) Only&#xD;
      children's intention and self-identity as a result of their cognition is related to&#xD;
      participation in physical activity to some extent(56). This suggests that educational&#xD;
      strategies aimed at increasing children's motivation remainan important strategy to promote&#xD;
      physical activity. Physical activity interventions have been done focusing on designing&#xD;
      interventions to overcome cultural, socioeconomic barriers in performing physical activity&#xD;
      based on psychosocial cognitive theory.(57)&#xD;
&#xD;
      A number of carefully designed studies incorporating health-related PE concepts and physical&#xD;
      activity in PE classes have been conducted. Dietary or physical activity behavior produce a&#xD;
      significant and clinically meaningful reduction in body mass index status of children and&#xD;
      adolescents in preventing obesity (58, 59) Alternatively behavioral prevention and&#xD;
      situational prevention elements have been combined to increase physical activity, decrease&#xD;
      the consumption of sugar-sweetened beverages, and decrease time spent with screen media(60).&#xD;
&#xD;
      Studies reporting positive outcomes implemented physical activity sessions that lasted at&#xD;
      least 30 min d(-1)?. Several studies showed that children are most active in the first 10-15&#xD;
      min. The existence or installation of playground markings or fixed play equipment had no&#xD;
      effect, whereas the presence or addition of portable play equipment was positively correlated&#xD;
      with moderate-to-vigorous physical activity.&#xD;
&#xD;
      Role of Parents and Teachers One of the interventions in promoting healthy lifestyle in&#xD;
      children is focusing on children, parents and teachers simultaneously by introducing learning&#xD;
      sessions and materials for healthy lifestyle.(32, 61)Teacher training may be a key element&#xD;
      for successful interventions. To overcome time constraints, a suggested solution is to&#xD;
      integrate physical activity into daily routines and other areas of the preschool&#xD;
      curriculum.(62)Additionally parental barriers are associated with the time that children&#xD;
      spend in both active and sedentary pursuits.(63) Knowledge about risk factors for obesity and&#xD;
      myocardial infarction is suboptimal in Pakistani adults(64).Only 42% adult students had a&#xD;
      good level of knowledge of modifiable risk factors of heart disease among patients with acute&#xD;
      myocardial infarction in Karachi.(65)Health education on physical activity and healthy diet&#xD;
      using multiple level intervention is essential to be given at schools.&#xD;
&#xD;
      1.2 Rationale Dietary behaviors, physical activity and sedentary lifestyle are independent&#xD;
      predictors of overweight and higher BMI among Pakistani primary school children.(66) Your&#xD;
      study does not focus on preschool children so it is better to write about school children.&#xD;
      Children skipping breakfast (8%), eating fast food and snacks ≥once a week (43%) and being&#xD;
      involved in sedentary lifestyle&gt;one hour a day (49%) were significantly more likely to be&#xD;
      overweight and obese while those participating in physical activity&gt;twice a week (53%) were&#xD;
      significantly less likely to be overweight and obese.(67) Approximately 85% of the students&#xD;
      had a predominantly sedentary life style, due to tuitions, television viewing or internet&#xD;
      surfing or indoor games like play stations in affluent schools of Karachi.(68)Most public&#xD;
      sector schools do not have designated physical trainers to encourage physical activity in&#xD;
      school children. Additionally unhealthy food including fast food, sugar sweetened beverages&#xD;
      are commonly available in the school canteens. Furthermore the television watching and&#xD;
      computers have added to physical inactivity making the children more sedentary. Most schools&#xD;
      do not have any health education curriculum which could be taught to children and no such&#xD;
      trial has been conducted in Pakistan A feasibility study using a similar design was done&#xD;
      including 276 children, in which 60 % spent &gt; 3 hours daily in watching TV or working on&#xD;
      computer. It was conducted in four public sector schools in Karachi. However due to limited&#xD;
      length of intervention of 20 weeks, clear benefits on cardiovascular outcomes like blood&#xD;
      pressure could not be observed (unpublished data).Additionally incorporating 30 min physical&#xD;
      activity was a challenging task and was not sustainable. Maybe this is something for the&#xD;
      summary since you already have said it :Schools are probably the most pragmatic place where&#xD;
      such shifts in lifestyle can be incorporated in adolescents.( figure 1) Strategies for&#xD;
      promoting physical activity at school level have been tested worldwide , however not at large&#xD;
      in Pakistan. Strategies need to be built in on large scale in adolescents, which can be&#xD;
      incorporated within their school boundry and time limitations. A multipronged approach&#xD;
      involving children, parents and teachers simultaneously is needed in school setup to make it&#xD;
      more successful. Using a multilevel approach to childhood obesity prevention including staff,&#xD;
      parents, and community partners is beneficial.(69) )&#xD;
&#xD;
      1.3.Main aim The main aim of the study is to incorporate a healthy lifestyle in children in&#xD;
      terms of increased physical activity, healthier dietary habits, and basic health education.&#xD;
      The hypothesis is that the programme will increase the level of physical activity not only at&#xD;
      school time but also at leisure time, increase the healthy dietary habits and have an effect&#xD;
      on cardiovascular outcomes.&#xD;
&#xD;
      1.4 Research Questions 1.4a. Research question I&#xD;
&#xD;
        -  What is the effect of a 10 months school health education program in Pakistan(SHEPP): vs&#xD;
           routine physical activity levels (in school, out of school, moderate to vigorous&#xD;
           physical activity and sedentary time) in school children ? 1.4b. Research questions II&#xD;
&#xD;
        -  What is the effect of a 10 months school health education program in Pakistan(SHEPP): vs&#xD;
           routine on intake of fruits and vegetable, sugar sweetened beverages and snacks&#xD;
           taken/day in school children ? 1.4c.Research question III&#xD;
&#xD;
        -  What is the effect of a 10 months school health education program in Pakistan(SHEPP)vs&#xD;
           routine on cardio metabolic risk factors; systolic blood pressure, diastolic blood&#xD;
           pressure, body mass index and waist circumference and body fat percentage in school&#xD;
           children?&#xD;
&#xD;
      1.5. Objectives 1.5a. Objective I&#xD;
&#xD;
        -  To compare the effect of a 10 months school health education program in Pakistan(SHEPP):&#xD;
           vs routine on physical activity levels (in school, out of school, moderate to vigorous&#xD;
           physical activity and sedentary time) in school children 1.5b. Objective II&#xD;
&#xD;
        -  To compare the effect of a 10 months school health education program in Pakistan(SHEPP):&#xD;
           vs routine on intake of fruits and vegetable, sugar sweetened beverage and snacks&#xD;
           taken/day in school children 1.5c.Objective III&#xD;
&#xD;
        -  To compare the effect of a 10 months school health education program in&#xD;
           Pakistan(SHEPP)vs routine on cardio metabolic risk factors; systolic blood pressure,&#xD;
           diastolic blood pressure, body mass index and waist circumference and body fat&#xD;
           percentage in school children&#xD;
&#xD;
           2. Methods 2.1 Study Design Study design and participants: Three schools under the Aga&#xD;
           Khan Education Service in Karachi will be included in a two-arm parallel cluster&#xD;
           intervention trial. All schools belong to lower to middle income class, at different&#xD;
           locations, all having the same school curriculum. Baseline data will be collected from&#xD;
           all three schools during a three month period by trained research staff. This would&#xD;
           comprise of data on sociodemographic factors, FFQ for diet, youth physical activity&#xD;
           questionnaire for physical activity, blood pressure ,weight, height and waist&#xD;
           circumference, body fat percentage measurements using validated instruments. Each school&#xD;
           will then be assigned to intervention or control (intervention in one school , and&#xD;
           control in 2 schools). All children aged 8-11 years enrolled in these schools will be&#xD;
           included. The rationale for this is that it is the period 8-11 years age where physical&#xD;
           activity starts to decline mainly in girls.(70) Follow up will be done after 10 months&#xD;
           of intervention. Ten months cutoff has been chosen as benefits on cardiovascular risk&#xD;
           factors are more pronounced at 10 month follow-up.(39)&#xD;
&#xD;
      2.2 Study Setting&#xD;
&#xD;
      Schools under the Aga Khan Education Service will be selected since they are all part of Aga&#xD;
      Khan Development network. These are:&#xD;
&#xD;
        1. Aga Khan School, Kharadhar&#xD;
&#xD;
        2. Aga Khan School, Garden&#xD;
&#xD;
        3. Sultan Mohamed Shah Aga Khan School, Karachi The reason for selection of these school is&#xD;
           that they follow a uniform curriculum across the school system. Additionally since they&#xD;
           are apart of the Aga Khan Development network, it would be more practical to work with&#xD;
           them. All schools are located in urban Karachi and Hyderabad. They have ample space to&#xD;
           conduct physical activity sessions, auditoriums and discussion room. Each school has&#xD;
           approximately 2000 students, both boys and girls. Each school comprises of 10 levels of&#xD;
           classes with 3-4 sections. The study is expected to be completed in 18 months to 20&#xD;
           months.&#xD;
&#xD;
      Intervention School health education program in Pakistan(SHEPP): The health education program&#xD;
      will be directed towards children, parents and teachers. The basis of designing such&#xD;
      intervention is to overcome cultural, socioeconomic barriers in performing physical activity&#xD;
      and is based on psychosocial cognitive theory.(57)The primary focus will be the&#xD;
      children.(figure II) Children 4. Programmed physical activity 140 minutes / week will be&#xD;
      targeted. i. 30 minutes twice a week will be delivered by teachers trained by expert physical&#xD;
      trainers. It would comprise of warm up, moderate to vigorous physical activity and cool&#xD;
      down(71).(30*2=60 min/week). These sessions will be lead by the school physical trainer under&#xD;
      supervision of an expert physical trainer (trained in aerobics) Different exercises is&#xD;
      introduced every month and discussions with students will be done by the research team as&#xD;
      well. A manual will be built to keep uniformity in the interventions. This has been&#xD;
      previously tested(71) ii. 10 minutes physical activity daily during assembly(10*5=50&#xD;
      minutes/week) iii. 1 minute between class warm up. (1*6*5=30 minutes/week) Children will be&#xD;
      encouraged to perform brake time physical activity by selecting leaders within a class&#xD;
      group(who will facilitate such PA in brake time)&#xD;
&#xD;
        -  Perform such PA in leisure time 4 times a week(atleast half an hour)&#xD;
&#xD;
        -  Before class exercises(2 minutes between periods)&#xD;
&#xD;
        -  Decrease levels of sedentary behavior(not more than hour) 5. Healthy diet teaching will&#xD;
           be given to children by a trained nutritionist. Healthy diet is based on food&#xD;
           pyramid.(72)There would be three sessions in all of one hour duration i. Encouragement&#xD;
           to increase fruits and vegetables intake serving in a day ii. Encouragement to avoid&#xD;
           sugar sweetened beverages iii. Encouragement to avoid fast food items 6. Healthy heart&#xD;
           teaching will be given by a trained physician. This would comprise of total 7 sessions&#xD;
           (one hour each). The study material for the children will be adapted from &quot;my heart&quot;&#xD;
           (www.bookgroup.org.pk, Children health fund). This material has been pilot tested&#xD;
           earlier in schools. It has basic information about heart. (AppendixA)&#xD;
&#xD;
        -  Heart&#xD;
&#xD;
        -  Blockage of arteries&#xD;
&#xD;
        -  Riskfactors for blockage&#xD;
&#xD;
        -  Diet&#xD;
&#xD;
        -  Physical activity&#xD;
&#xD;
        -  Smoking and smokeless tobacco&#xD;
&#xD;
        -  Hand and dental Hygiene&#xD;
&#xD;
        -  Anger mangement Parents Group health education to parents-will be done by the team of&#xD;
           trained nutritionist, physician and teachers. Teachers will be trained to teach parents.&#xD;
           This will be done on weekends in large class format. It would comprise of one hour each.&#xD;
&#xD;
             1. Health problems in Pakistan&#xD;
&#xD;
             2. Physical activity as a preventive measure&#xD;
&#xD;
             3. Healthy diet as a preventive measure Parents will then reinforce these habits in&#xD;
                their children and will ask them atleast twice a week.(Did ypu do physical activity&#xD;
                at school and home?Did you have atleast one fruit or vegetable today?) Teachers The&#xD;
                teachers will be trained by a team of experts including a physician, a nutritionist&#xD;
                and a physical activity expert. A teachers guide will be developed.(Appendix B)This&#xD;
                comprises of&#xD;
&#xD;
        -  Heart&#xD;
&#xD;
        -  Blockage of arteries&#xD;
&#xD;
        -  Risk factors for blockage&#xD;
&#xD;
        -  Diet&#xD;
&#xD;
        -  Physical activity&#xD;
&#xD;
        -  Smoking and smokeless tobacco&#xD;
&#xD;
        -  Hand and dental Hygiene&#xD;
&#xD;
        -  Anger management The teachers will then reinforce about healthy physical activity and&#xD;
           diet in class once /week (did you do physical activity at home and school?How many times&#xD;
           did you take fruits and vegatables?).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>: Three schools under the Aga Khan Education Service in Karachi will be included in a two-arm parallel cluster intervention trial. All schools belong to lower to middle income class, at different locations, all having the same school curriculum. Baseline data will be collected from all three schools during a three month period by trained research staff</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>increase in Minutes spent in school, out of school in physical activity</measure>
    <time_frame>10 months</time_frame>
    <description>• Physical activity levels(in school, out of school, moderate to vigorous physical activity and sedentary time) assessed by number of minutes spent in physical activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>decrease in blood pressure in mm</measure>
    <time_frame>10 months</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decrease in BMI in kg/m2</measure>
    <time_frame>10 months</time_frame>
    <description>BMI= weight in kg/height in meter square</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>increase in Number of fruits and vegetable/ decrease in sweetened beverages in a day</measure>
    <time_frame>10 months</time_frame>
    <description>• Dietary patterns in terms of fruits and vegetable serving, sweetened beverages and snacks/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in waist circumference in cm</measure>
    <time_frame>10 months</time_frame>
    <description>Decrease in waist circumference in cm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Health Education</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School health education</intervention_name>
    <description>School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children aged 8-11 years enrolled in the schools.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any child or adolescent suffering from any physical disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aysha Almas, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aysha Almas, FCPS</last_name>
    <phone>9221-34930051</phone>
    <email>aysha.almas@aku.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aga Khan Schools</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anila Allana</last_name>
      <email>anila.allana@akesp.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Aysha Almas</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>health education</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03303287
org study id: HEC_4553
nct id: NCT03303287
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pakistan is a developing country and there have been a considerable rise in obesity and
      hypertension in children in recent years. In this setting a focus on primary prevention of
      cardiovascular diseases is more cost effective than spending resources on secondary or
      tertiary prevention,. Primary prevention includes interventions to promote physical activity
      (> 30 minutes/day in school), healthy dietary habits (decreased consumption of sweetened
      beverages and snacks, and increased consumption of fruit and vegetables) and health education
      focusing on cardiovascular risk factors in school children. This would translate into
      healthier cardiovascular outcomes (eg. less hypertension, dyslipidemia and diabetes) in adult
      life. The investigators propose a school health education program for Pakistan (SHEPP) for
      children aged 9-11 years in 3 schools in Karachi for a period of one year. This program will
      comprise of 140 minutes physical activity/week (including aerobics):30 minutes aerobic
      PA(30*2=60) + 10 minutes (10*5=50)physical activity in assembly daily+ 1 minute between
      periods(1*6*5=30) and healthy diet and healthy heart teaching. Additionally teaching will
      also be given to teachers and parents, who will further reinforce these habits in children.
      We hypothesise that SHEPP will improve physical activity levels, dietary habits and knowledge
      about healthy heart in children, will decrease blood pressure, body mass index, waist
      circumference, at the end of the year. If this healthy behavior is carried on to adult life
      it will serve as an excellent primary prevention measure. The investigators , later on plan
      to study long term outcomes after implementation of this intervention.
1.1.Interventions to reduce childhood obesity School based programs have also been introduced
      as interventions to assess the impact on blood pressure ant weight. In effectiveness trial
      done by Yin et al on the impact of 8 months after school physical activity programme
      demonstrated a reduction in percentage body fat, but no effect on blood pressure.(52) Schools
      have been unable to provide sufficient time and resources for students to meet all the
      objectives of standard physical education, the concept of "health-related
      PE".(13)Traditionally, the role of schools in providing and promoting physical activity has
      been during the school day (eg, PE, recess) and/or on the school campus immediately after
      school. Trial of Activity for Adolescent Girls (TAAG) is a large-scale randomized trial
      involving 36 schools at 6 study sites across the United States and sponsored by the National
      Heart, Lung, and Blood Institute. This large-scale study is examining the effects of a
      school-community linked intervention on overall physical activity in middle school girls.(53)

      Physical activity and behavior of change theory The effectiveness of physical activity
      interventions would benefit from a better understanding of this behavior. (54) Theory of
      planned behavior has demonstrated usefulness in studies of health-related behavior.(55) Only
      children's intention and self-identity as a result of their cognition is related to
      participation in physical activity to some extent(56). This suggests that educational
      strategies aimed at increasing children's motivation remainan important strategy to promote
      physical activity. Physical activity interventions have been done focusing on designing
      interventions to overcome cultural, socioeconomic barriers in performing physical activity
      based on psychosocial cognitive theory.(57)

      A number of carefully designed studies incorporating health-related PE concepts and physical
      activity in PE classes have been conducted. Dietary or physical activity behavior produce a
      significant and clinically meaningful reduction in body mass index status of children and
      adolescents in preventing obesity (58, 59) Alternatively behavioral prevention and
      situational prevention elements have been combined to increase physical activity, decrease
      the consumption of sugar-sweetened beverages, and decrease time spent with screen media(60).

      Studies reporting positive outcomes implemented physical activity sessions that lasted at
      least 30 min d(-1)?. Several studies showed that children are most active in the first 10-15
      min. The existence or installation of playground markings or fixed play equipment had no
      effect, whereas the presence or addition of portable play equipment was positively correlated
      with moderate-to-vigorous physical activity.

      Role of Parents and Teachers One of the interventions in promoting healthy lifestyle in
      children is focusing on children, parents and teachers simultaneously by introducing learning
      sessions and materials for healthy lifestyle.(32, 61)Teacher training may be a key element
      for successful interventions. To overcome time constraints, a suggested solution is to
      integrate physical activity into daily routines and other areas of the preschool
      curriculum.(62)Additionally parental barriers are associated with the time that children
      spend in both active and sedentary pursuits.(63) Knowledge about risk factors for obesity and
      myocardial infarction is suboptimal in Pakistani adults(64).Only 42% adult students had a
      good level of knowledge of modifiable risk factors of heart disease among patients with acute
      myocardial infarction in Karachi.(65)Health education on physical activity and healthy diet
      using multiple level intervention is essential to be given at schools.

      1.2 Rationale Dietary behaviors, physical activity and sedentary lifestyle are independent
      predictors of overweight and higher BMI among Pakistani primary school children.(66) Your
      study does not focus on preschool children so it is better to write about school children.
      Children skipping breakfast (8%), eating fast food and snacks ≥once a week (43%) and being
      involved in sedentary lifestyle>one hour a day (49%) were significantly more likely to be
      overweight and obese while those participating in physical activity>twice a week (53%) were
      significantly less likely to be overweight and obese.(67) Approximately 85% of the students
      had a predominantly sedentary life style, due to tuitions, television viewing or internet
      surfing or indoor games like play stations in affluent schools of Karachi.(68)Most public
      sector schools do not have designated physical trainers to encourage physical activity in
      school children. Additionally unhealthy food including fast food, sugar sweetened beverages
      are commonly available in the school canteens. Furthermore the television watching and
      computers have added to physical inactivity making the children more sedentary. Most schools
      do not have any health education curriculum which could be taught to children and no such
      trial has been conducted in Pakistan A feasibility study using a similar design was done
      including 276 children, in which 60 % spent > 3 hours daily in watching TV or working on
      computer. It was conducted in four public sector schools in Karachi. However due to limited
      length of intervention of 20 weeks, clear benefits on cardiovascular outcomes like blood
      pressure could not be observed (unpublished data).Additionally incorporating 30 min physical
      activity was a challenging task and was not sustainable. Maybe this is something for the
      summary since you already have said it :Schools are probably the most pragmatic place where
      such shifts in lifestyle can be incorporated in adolescents.( figure 1) Strategies for
      promoting physical activity at school level have been tested worldwide , however not at large
      in Pakistan. Strategies need to be built in on large scale in adolescents, which can be
      incorporated within their school boundry and time limitations. A multipronged approach
      involving children, parents and teachers simultaneously is needed in school setup to make it
      more successful. Using a multilevel approach to childhood obesity prevention including staff,
      parents, and community partners is beneficial.(69) )

      1.3.Main aim The main aim of the study is to incorporate a healthy lifestyle in children in
      terms of increased physical activity, healthier dietary habits, and basic health education.
      The hypothesis is that the programme will increase the level of physical activity not only at
      school time but also at leisure time, increase the healthy dietary habits and have an effect
      on cardiovascular outcomes.

      1.4 Research Questions 1.4a. Research question I

        -  What is the effect of a 10 months school health education program in Pakistan(SHEPP): vs
           routine physical activity levels (in school, out of school, moderate to vigorous
           physical activity and sedentary time) in school children ? 1.4b. Research questions II

        -  What is the effect of a 10 months school health education program in Pakistan(SHEPP): vs
           routine on intake of fruits and vegetable, sugar sweetened beverages and snacks
           taken/day in school children ? 1.4c.Research question III

        -  What is the effect of a 10 months school health education program in Pakistan(SHEPP)vs
           routine on cardio metabolic risk factors; systolic blood pressure, diastolic blood
           pressure, body mass index and waist circumference and body fat percentage in school
           children?

      1.5. Objectives 1.5a. Objective I

        -  To compare the effect of a 10 months school health education program in Pakistan(SHEPP):
           vs routine on physical activity levels (in school, out of school, moderate to vigorous
           physical activity and sedentary time) in school children 1.5b. Objective II

        -  To compare the effect of a 10 months school health education program in Pakistan(SHEPP):
           vs routine on intake of fruits and vegetable, sugar sweetened beverage and snacks
           taken/day in school children 1.5c.Objective III

        -  To compare the effect of a 10 months school health education program in
           Pakistan(SHEPP)vs routine on cardio metabolic risk factors; systolic blood pressure,
           diastolic blood pressure, body mass index and waist circumference and body fat
           percentage in school children

           2. Methods 2.1 Study Design Study design and participants: Three schools under the Aga
           Khan Education Service in Karachi will be included in a two-arm parallel cluster
           intervention trial. All schools belong to lower to middle income class, at different
           locations, all having the same school curriculum. Baseline data will be collected from
           all three schools during a three month period by trained research staff. This would
           comprise of data on sociodemographic factors, FFQ for diet, youth physical activity
           questionnaire for physical activity, blood pressure ,weight, height and waist
           circumference, body fat percentage measurements using validated instruments. Each school
           will then be assigned to intervention or control (intervention in one school , and
           control in 2 schools). All children aged 8-11 years enrolled in these schools will be
           included. The rationale for this is that it is the period 8-11 years age where physical
           activity starts to decline mainly in girls.(70) Follow up will be done after 10 months
           of intervention. Ten months cutoff has been chosen as benefits on cardiovascular risk
           factors are more pronounced at 10 month follow-up.(39)

      2.2 Study Setting

      Schools under the Aga Khan Education Service will be selected since they are all part of Aga
      Khan Development network. These are:

        1. Aga Khan School, Kharadhar

        2. Aga Khan School, Garden

        3. Sultan Mohamed Shah Aga Khan School, Karachi The reason for selection of these school is
           that they follow a uniform curriculum across the school system. Additionally since they
           are apart of the Aga Khan Development network, it would be more practical to work with
           them. All schools are located in urban Karachi and Hyderabad. They have ample space to
           conduct physical activity sessions, auditoriums and discussion room. Each school has
           approximately 2000 students, both boys and girls. Each school comprises of 10 levels of
           classes with 3-4 sections. The study is expected to be completed in 18 months to 20
           months.

      Intervention School health education program in Pakistan(SHEPP): The health education program
      will be directed towards children, parents and teachers. The basis of designing such
      intervention is to overcome cultural, socioeconomic barriers in performing physical activity
      and is based on psychosocial cognitive theory.(57)The primary focus will be the
      children.(figure II) Children 4. Programmed physical activity 140 minutes / week will be
      targeted. i. 30 minutes twice a week will be delivered by teachers trained by expert physical
      trainers. It would comprise of warm up, moderate to vigorous physical activity and cool
      down(71).(30*2=60 min/week). These sessions will be lead by the school physical trainer under
      supervision of an expert physical trainer (trained in aerobics) Different exercises is
      introduced every month and discussions with students will be done by the research team as
      well. A manual will be built to keep uniformity in the interventions. This has been
      previously tested(71) ii. 10 minutes physical activity daily during assembly(10*5=50
      minutes/week) iii. 1 minute between class warm up. (1*6*5=30 minutes/week) Children will be
      encouraged to perform brake time physical activity by selecting leaders within a class
      group(who will facilitate such PA in brake time)

        -  Perform such PA in leisure time 4 times a week(atleast half an hour)

        -  Before class exercises(2 minutes between periods)

        -  Decrease levels of sedentary behavior(not more than hour) 5. Healthy diet teaching will
           be given to children by a trained nutritionist. Healthy diet is based on food
           pyramid.(72)There would be three sessions in all of one hour duration i. Encouragement
           to increase fruits and vegetables intake serving in a day ii. Encouragement to avoid
           sugar sweetened beverages iii. Encouragement to avoid fast food items 6. Healthy heart
           teaching will be given by a trained physician. This would comprise of total 7 sessions
           (one hour each). The study material for the children will be adapted from "my heart"
           (www.bookgroup.org.pk, Children health fund). This material has been pilot tested
           earlier in schools. It has basic information about heart. (AppendixA)

        -  Heart

        -  Blockage of arteries

        -  Riskfactors for blockage

        -  Diet

        -  Physical activity

        -  Smoking and smokeless tobacco

        -  Hand and dental Hygiene

        -  Anger mangement Parents Group health education to parents-will be done by the team of
           trained nutritionist, physician and teachers. Teachers will be trained to teach parents.
           This will be done on weekends in large class format. It would comprise of one hour each.

             1. Health problems in Pakistan

             2. Physical activity as a preventive measure

             3. Healthy diet as a preventive measure Parents will then reinforce these habits in
                their children and will ask them atleast twice a week.(Did ypu do physical activity
                at school and home?Did you have atleast one fruit or vegetable today?) Teachers The
                teachers will be trained by a team of experts including a physician, a nutritionist
                and a physical activity expert. A teachers guide will be developed.(Appendix B)This
                comprises of

        -  Heart

        -  Blockage of arteries

        -  Risk factors for blockage

        -  Diet

        -  Physical activity

        -  Smoking and smokeless tobacco

        -  Hand and dental Hygiene

        -  Anger management The teachers will then reinforce about healthy physical activity and
           diet in class once /week (did you do physical activity at home and school?How many times
           did you take fruits and vegatables?).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: : Three schools under the Aga Khan Education Service in Karachi will be included in a two-arm parallel cluster intervention trial. All schools belong to lower to middle income class, at different locations, all having the same school curriculum. Baseline data will be collected from all three schools during a three month period by trained research staff
primary purpose: Prevention
masking: None (Open Label)
measure: increase in Minutes spent in school, out of school in physical activity
time frame: 10 months
description: • Physical activity levels(in school, out of school, moderate to vigorous physical activity and sedentary time) assessed by number of minutes spent in physical activity
measure: decrease in blood pressure in mm
time frame: 10 months
description: blood pressure
measure: decrease in BMI in kg/m2
time frame: 10 months
description: BMI= weight in kg/height in meter square
measure: increase in Number of fruits and vegetable/ decrease in sweetened beverages in a day
time frame: 10 months
description: • Dietary patterns in terms of fruits and vegetable serving, sweetened beverages and snacks/day
measure: Decrease in waist circumference in cm
time frame: 10 months
description: Decrease in waist circumference in cm
arm group label: intervention
arm group type: Experimental
description: School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers
arm group label: control
arm group type: No Intervention
description: usual
intervention type: Behavioral
intervention name: School health education
description: School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers
arm group label: intervention
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aysha Almas, FCPS
role: Principal Investigator
affiliation: Aga Khan University
last name: Aysha Almas, FCPS
phone: 9221-34930051
email: aysha.almas@aku.edu
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Aysha Almas
investigator title: Associate professor
sharing ipd: Undecided