<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/NCT03263377</url>
  </required_header>
  <id_info>
    <org_study_id>PR-11052</org_study_id>
    <nct_id>NCT03263377</nct_id>
  </id_info>
  <brief_title>The Impact on School Feeding on Children's Growth and Development</brief_title>
  <acronym>schoolfeed</acronym>
  <official_title>The Impact on School Feeding on Children's Growth and Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Union</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to improve child nutrition, the Poverty Reduction Strategy adopted by the Government&#xD;
      of Bangladesh (GoB) has called for the initiation of a school feeding programme for primary&#xD;
      school children living in poor and disadvantaged families and communities where the&#xD;
      prevalence of child malnutrition is high. Accordingly, a pilot feeding programme is planned&#xD;
      for implementation in Government and NGO schools in 10 Upazilas in rural Bangladesh with the&#xD;
      aim of: 1) enhancing the nutritional status and growth of younger school-going children by&#xD;
      reducing micronutrient deficiencies and providing a protein/calorie supplement; 2) improving&#xD;
      learning capacity and attentiveness in the classroom; 3) increasing enrollment, attendance&#xD;
      and completion rates and 4) supporting the goals of achieving universal primary education and&#xD;
      reducing gender disparity.&#xD;
&#xD;
      The objectives of the proposed baseline survey respond to GoB's aims:&#xD;
&#xD;
        1. To assess the nutrition status of younger school-going children prior to the initiation&#xD;
           of a school feeding programme, thus enabling the later assessment of programme impact on&#xD;
           micronutrient deficiencies and anthropometric indicators.&#xD;
&#xD;
        2. To assess the cognitive performance and school attendance of children prior to the&#xD;
           initiation of a school feeding programme thus enabling the later assessment of programme&#xD;
           impact on school enrollment and attendance, and learning capacity.&#xD;
&#xD;
      The baseline study will be conducted using a cluster randomized study design in which schools&#xD;
      represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10&#xD;
      that have been selected for intervention. A control group will be included in study design&#xD;
      consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated&#xD;
      for inclusion in the feeding programme. Use of a control group will enable later evaluations&#xD;
      to attribute possible improvements in key impact/outcome variables to the intervention&#xD;
      itself. A mid term evaluation will be conducted 6 months after the baseline survey. Finally,&#xD;
      an impact evaluation will be conducted on the same children 10-14 months after the baseline&#xD;
      survey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To enable useful comparison, FSNSP will adapt the study design used by World Food Programme&#xD;
      to evaluate a similar school feeding intervention undertaken in chronically food insecure&#xD;
      areas in rural Bangladesh during the period 2002-04. The baseline study will be conducted&#xD;
      using a cluster randomized study design in which schools represent clusters. Seven schools&#xD;
      will be randomly selected from each of 7 Upazilas out of 10 that have been selected for&#xD;
      intervention. A control group will be included in study design consisting of 7 schools&#xD;
      selected randomly from 7 comparable yet adjacent Upazilas not slated for inclusion in the&#xD;
      feeding programme. Control groups will share the same socio-economic, geographic background&#xD;
      characteristics of adjacent intervention schools, but are located in Upazilas that have not&#xD;
      been selected by GoB to be part of the pilot School Feeding Programme. Use of a control group&#xD;
      will enable later evaluations to attribute possible improvements in key impact/outcome&#xD;
      variables to the intervention itself. A mid-term followup and endline study will be conducted&#xD;
      on the same children approximately 6 months and 10-12 months following baseline. The precise&#xD;
      timing of follow-up will be a function of when biscuit distribution is initiated, and&#xD;
      seasonal period. Care will be taken to capture the same season as the baseline (to control&#xD;
      for seasonal availability of fruits and vegetables), and to ensure that follow-up occurs&#xD;
      before the Ramadan period when normal food consumption patterns are disrupted.&#xD;
&#xD;
      The baseline study will consist of data collected at individual (child), household (mother)&#xD;
      and institutional (school) levels. Study methods will include: 1) a structured survey&#xD;
      questionnaire delivered to teachers, school children, and their mothers; 2) In-depth&#xD;
      interviews/focus groups with teachers, community members and NGO implementers; 3) data&#xD;
      abstraction from school records; 4) anthropometric and cognitive measures of all primary&#xD;
      school students, and 5) biological measures on a sub-sample of children. Programme staff will&#xD;
      be consulted in the design and piloting of study instruments, and in thinking about how to&#xD;
      best accommodate monitoring and evaluation activities into project design.&#xD;
&#xD;
      7. Structured Surveys The student survey questionnaire will comprise of a series of questions&#xD;
      that assess what they have eaten recently, as well perceptions of satiety, hunger, energy&#xD;
      levels, ability to concentrate, and whether there have been recent school absences.&#xD;
&#xD;
      The mother's questionnaire will cover background information concerning household food&#xD;
      security and socio-economic status, as well as information on the child's eating practices,&#xD;
      recent morbidity, and personal assessment of child's energy level, concentration and&#xD;
      irritability.&#xD;
&#xD;
      A teacher's questionnaire queries their perceptions and experience in the classroom regarding&#xD;
      the behavior of children in the classroom.&#xD;
&#xD;
      8. In-depth Interviews In-depth interviews with teachers, school officials and NGO&#xD;
      implementer will be undertaken to assess attitudes, expectations and plans regarding the&#xD;
      school feeding program (in intervention schools only), and whether any other school-based&#xD;
      nutrition or health programmes had ever been implemented in the area.&#xD;
&#xD;
      9. School Records Information on school infrastructure (toilet, water supply), schedules,&#xD;
      management structures (school committees) will be collected, and data on school attendance,&#xD;
      and enrollment (over the past 3 years), will be extracted from school records.&#xD;
&#xD;
      10. Anthropometry and Cognitive Measures Following the administration of the student survey,&#xD;
      measures of height and weight will be taken on each child interviewed, and a short cognitive&#xD;
      test &quot;Raven's Matrices&quot; will be administered.&#xD;
&#xD;
      Weight of the children will be measured to the nearest 100 g using a digital scale. Height of&#xD;
      the child will be determined with a locally constructed instrument in which a plastic tape&#xD;
      measure is extended between a footplate and head bar. Height will be measured within 0.1 cm.&#xD;
      The mean of three consecutive measurements (height and weight) will be considered as the&#xD;
      observed value. This will be done during data analysis. All measurements will subsequently be&#xD;
      compared to the standards according to the WHO 2006 growth standards and the nutritional&#xD;
      status will be assessed by z-score. All anthropometric measurements will be performed by&#xD;
      trained and experienced field workers following standard procedures.&#xD;
&#xD;
      Raven's Progressive Matrices (often referred to simply as Raven's Matrices) are non-verbal&#xD;
      multiple choice measures of the reasoning (or, better, &quot;meaning-making&quot;) component of&#xD;
      Spearman's g, which is often referred to as general intelligence. The tests were originally&#xD;
      developed by John C. Raven in 1936. In each test item, the subject is asked to identify the&#xD;
      missing element that completes a pattern. Many patterns are presented in the form of a 4x4,&#xD;
      3x3, or 2x2 matrix, giving the test its name.&#xD;
&#xD;
      It is developed based on simple measures of the two main components of Spearman's g viz. (1)&#xD;
      the ability to think clearly and make sense of complexity, which is known as eductive ability&#xD;
      (from the Latin root &quot;educere&quot;, meaning &quot;to draw out&quot;) and (2) the ability to store and&#xD;
      reproduce information, known as reproductive ability.&#xD;
&#xD;
      Raven's CPM is designed for young children ages 5:0-11:0 years and older adults. The test&#xD;
      consists of 36 items in 3 sets (A, Ab, B), with 12 items per set arranged to assess the chief&#xD;
      cognitive processes of which children under 11 years of age are usually capable. The CPM&#xD;
      items are arranged to assess cognitive development up to the stage when a person is&#xD;
      sufficiently able to reason by analogy and adopt this way of thinking as a consistent method&#xD;
      of inference.&#xD;
&#xD;
      The Raven's CPM produces a single raw score that can be converted to a percentile based on&#xD;
      normative data collected from various groups.&#xD;
&#xD;
      Although RAVEN was developed for research purposes, because of its independence of language&#xD;
      and reading and writing skills, and simplicity of use and interpretation, it has found&#xD;
      widespread application internationally (10,11). RAVEN has been deployed successfully among&#xD;
      young children in Bangladesh (personal communication with Jena Hamadani, Fahmida Tofail), and&#xD;
      Bengali training guides have been developed.&#xD;
&#xD;
      11. Biochemical Measures, Assessments of haemoglobin, Other biochemical tests will be&#xD;
      performed on a separate portion of blood (1.5 mL). These include: Assessments of C-reative&#xD;
      protein. Assessments of serum ferritin, Assessments of retinol Assessments of folic acid,&#xD;
      Assessments of Vitamin B12, We also use pool serum as internal quality control. We&#xD;
      participate CDC vital EQA program for serum vitamin B12&#xD;
&#xD;
      Assessments of Zinc, Assessments of 25-Hydroxy Vitamin, Assessments of urinary iodine&#xD;
&#xD;
      Sampling technique To enroll a sufficiently sized random sample of eligible school children,&#xD;
      we will obtain lists of children in Classes 1-3 from the school authority. Participating&#xD;
      school children will be selected randomly from these lists through computer-generated random&#xD;
      numbers. An equal number of boys and girls will be selected from each class to enable gender&#xD;
      analysis. Schoolteachers will assist in identifying and contacting all randomly-selected&#xD;
      children and their mothers at household level. In the case of a school child who is randomly&#xD;
      selected but is not present at the school due to illness, dropout etc., the subsequent child&#xD;
      on class list will be selected. Children whose cognitive abilities are are challenged by&#xD;
      autism, mental issues or iodine deficiency will be excluded from the study.&#xD;
&#xD;
      Assuming a mean weight of 22.4 kg (SD=3.0 kg); and SFP is expected to increase the mean&#xD;
      weight from 22.4 kg to 24.0 kg, thus to detect a difference of 1.6 kg with 90% power and type&#xD;
      I error=0.05, design effect=2.0 and 10% drop-outs, the necessary sample-size calculated to be&#xD;
      at least 164 school children in each group. This is less than the sample size required for&#xD;
      BMI.&#xD;
&#xD;
      For collection of blood and urine sample we will first randomly select a school from the&#xD;
      upazila school list. Than again randomization will be performed for selection of children for&#xD;
      specimen collection from the study participating children of that school.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Children's weight at 14 months</measure>
    <time_frame>Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)</time_frame>
    <description>Children's weight were measured by WHO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Children's Height at 14 months</measure>
    <time_frame>Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)</time_frame>
    <description>Children's Height were measured by WHO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Children's nutritional impact at 14 months</measure>
    <time_frame>Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)</time_frame>
    <description>Child anaemia and micronutrient deficiency: biochemical analyses of blood specimens</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Children's cognitive performance and school attendance at 14 months</measure>
    <time_frame>Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)</time_frame>
    <description>Subjective assessment of child sleepiness/attentiveness/concentration/irritability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3006</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The baseline study will be conducted using a cluster randomized study design in which schools represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10 that have been selected for intervention. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium. Children whose cognitive abilities are are challenged by autism, mental issues or iodine deficiency will be excluded from the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A control group will be included in study design consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated for inclusion in the feeding programme. Use of a control group will enable later evaluations to attribute possible improvements in key impact/outcome variables to the intervention itself. An equal number of boys and girls will be selected from each class to enable gender analysis. Children whose cognitive abilities are are challenged by autism, mental issues or iodine deficiency will be excluded from the study.No intervention had given in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>The school feeding intervention</intervention_name>
    <description>The baseline study will be conducted using a cluster randomized study design in which schools represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10 that have been selected for intervention. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium.</description>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>Non Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  5-11 years of school children&#xD;
&#xD;
          -  Giving Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 12 years of age&#xD;
&#xD;
          -  Refuse consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Powell CA, Walker SP, Chang SM, Grantham-McGregor SM. Nutrition and education: a randomized trial of the effects of breakfast in rural primary school children. Am J Clin Nutr. 1998 Oct;68(4):873-9. doi: 10.1093/ajcn/68.4.873.</citation>
    <PMID>9771865</PMID>
  </results_reference>
  <results_reference>
    <citation>Simeon DT. School feeding in Jamaica: a review of its evaluation. Am J Clin Nutr. 1998 Apr;67(4):790S-794S. doi: 10.1093/ajcn/67.4.790S.</citation>
    <PMID>9537630</PMID>
  </results_reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>June 5, 2016</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>School feeding</keyword>
  <keyword>Fortified Biscuits</keyword>
  <keyword>Bangladesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <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/NCT03263377
org study id: PR-11052
nct id: NCT03263377
lead sponsor: 
collaborator: 
has dmc: Yes
In order to improve child nutrition, the Poverty Reduction Strategy adopted by the Government
      of Bangladesh (GoB) has called for the initiation of a school feeding programme for primary
      school children living in poor and disadvantaged families and communities where the
      prevalence of child malnutrition is high. Accordingly, a pilot feeding programme is planned
      for implementation in Government and NGO schools in 10 Upazilas in rural Bangladesh with the
      aim of: 1) enhancing the nutritional status and growth of younger school-going children by
      reducing micronutrient deficiencies and providing a protein/calorie supplement; 2) improving
      learning capacity and attentiveness in the classroom; 3) increasing enrollment, attendance
      and completion rates and 4) supporting the goals of achieving universal primary education and
      reducing gender disparity.

      The objectives of the proposed baseline survey respond to GoB's aims:

        1. To assess the nutrition status of younger school-going children prior to the initiation
           of a school feeding programme, thus enabling the later assessment of programme impact on
           micronutrient deficiencies and anthropometric indicators.

        2. To assess the cognitive performance and school attendance of children prior to the
           initiation of a school feeding programme thus enabling the later assessment of programme
           impact on school enrollment and attendance, and learning capacity.

      The baseline study will be conducted using a cluster randomized study design in which schools
      represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10
      that have been selected for intervention. A control group will be included in study design
      consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated
      for inclusion in the feeding programme. Use of a control group will enable later evaluations
      to attribute possible improvements in key impact/outcome variables to the intervention
      itself. A mid term evaluation will be conducted 6 months after the baseline survey. Finally,
      an impact evaluation will be conducted on the same children 10-14 months after the baseline
      survey.
To enable useful comparison, FSNSP will adapt the study design used by World Food Programme
      to evaluate a similar school feeding intervention undertaken in chronically food insecure
      areas in rural Bangladesh during the period 2002-04. The baseline study will be conducted
      using a cluster randomized study design in which schools represent clusters. Seven schools
      will be randomly selected from each of 7 Upazilas out of 10 that have been selected for
      intervention. A control group will be included in study design consisting of 7 schools
      selected randomly from 7 comparable yet adjacent Upazilas not slated for inclusion in the
      feeding programme. Control groups will share the same socio-economic, geographic background
      characteristics of adjacent intervention schools, but are located in Upazilas that have not
      been selected by GoB to be part of the pilot School Feeding Programme. Use of a control group
      will enable later evaluations to attribute possible improvements in key impact/outcome
      variables to the intervention itself. A mid-term followup and endline study will be conducted
      on the same children approximately 6 months and 10-12 months following baseline. The precise
      timing of follow-up will be a function of when biscuit distribution is initiated, and
      seasonal period. Care will be taken to capture the same season as the baseline (to control
      for seasonal availability of fruits and vegetables), and to ensure that follow-up occurs
      before the Ramadan period when normal food consumption patterns are disrupted.

      The baseline study will consist of data collected at individual (child), household (mother)
      and institutional (school) levels. Study methods will include: 1) a structured survey
      questionnaire delivered to teachers, school children, and their mothers; 2) In-depth
      interviews/focus groups with teachers, community members and NGO implementers; 3) data
      abstraction from school records; 4) anthropometric and cognitive measures of all primary
      school students, and 5) biological measures on a sub-sample of children. Programme staff will
      be consulted in the design and piloting of study instruments, and in thinking about how to
      best accommodate monitoring and evaluation activities into project design.

      7. Structured Surveys The student survey questionnaire will comprise of a series of questions
      that assess what they have eaten recently, as well perceptions of satiety, hunger, energy
      levels, ability to concentrate, and whether there have been recent school absences.

      The mother's questionnaire will cover background information concerning household food
      security and socio-economic status, as well as information on the child's eating practices,
      recent morbidity, and personal assessment of child's energy level, concentration and
      irritability.

      A teacher's questionnaire queries their perceptions and experience in the classroom regarding
      the behavior of children in the classroom.

      8. In-depth Interviews In-depth interviews with teachers, school officials and NGO
      implementer will be undertaken to assess attitudes, expectations and plans regarding the
      school feeding program (in intervention schools only), and whether any other school-based
      nutrition or health programmes had ever been implemented in the area.

      9. School Records Information on school infrastructure (toilet, water supply), schedules,
      management structures (school committees) will be collected, and data on school attendance,
      and enrollment (over the past 3 years), will be extracted from school records.

      10. Anthropometry and Cognitive Measures Following the administration of the student survey,
      measures of height and weight will be taken on each child interviewed, and a short cognitive
      test "Raven's Matrices" will be administered.

      Weight of the children will be measured to the nearest 100 g using a digital scale. Height of
      the child will be determined with a locally constructed instrument in which a plastic tape
      measure is extended between a footplate and head bar. Height will be measured within 0.1 cm.
      The mean of three consecutive measurements (height and weight) will be considered as the
      observed value. This will be done during data analysis. All measurements will subsequently be
      compared to the standards according to the WHO 2006 growth standards and the nutritional
      status will be assessed by z-score. All anthropometric measurements will be performed by
      trained and experienced field workers following standard procedures.

      Raven's Progressive Matrices (often referred to simply as Raven's Matrices) are non-verbal
      multiple choice measures of the reasoning (or, better, "meaning-making") component of
      Spearman's g, which is often referred to as general intelligence. The tests were originally
      developed by John C. Raven in 1936. In each test item, the subject is asked to identify the
      missing element that completes a pattern. Many patterns are presented in the form of a 4x4,
      3x3, or 2x2 matrix, giving the test its name.

      It is developed based on simple measures of the two main components of Spearman's g viz. (1)
      the ability to think clearly and make sense of complexity, which is known as eductive ability
      (from the Latin root "educere", meaning "to draw out") and (2) the ability to store and
      reproduce information, known as reproductive ability.

      Raven's CPM is designed for young children ages 5:0-11:0 years and older adults. The test
      consists of 36 items in 3 sets (A, Ab, B), with 12 items per set arranged to assess the chief
      cognitive processes of which children under 11 years of age are usually capable. The CPM
      items are arranged to assess cognitive development up to the stage when a person is
      sufficiently able to reason by analogy and adopt this way of thinking as a consistent method
      of inference.

      The Raven's CPM produces a single raw score that can be converted to a percentile based on
      normative data collected from various groups.

      Although RAVEN was developed for research purposes, because of its independence of language
      and reading and writing skills, and simplicity of use and interpretation, it has found
      widespread application internationally (10,11). RAVEN has been deployed successfully among
      young children in Bangladesh (personal communication with Jena Hamadani, Fahmida Tofail), and
      Bengali training guides have been developed.

      11. Biochemical Measures, Assessments of haemoglobin, Other biochemical tests will be
      performed on a separate portion of blood (1.5 mL). These include: Assessments of C-reative
      protein. Assessments of serum ferritin, Assessments of retinol Assessments of folic acid,
      Assessments of Vitamin B12, We also use pool serum as internal quality control. We
      participate CDC vital EQA program for serum vitamin B12

      Assessments of Zinc, Assessments of 25-Hydroxy Vitamin, Assessments of urinary iodine

      Sampling technique To enroll a sufficiently sized random sample of eligible school children,
      we will obtain lists of children in Classes 1-3 from the school authority. Participating
      school children will be selected randomly from these lists through computer-generated random
      numbers. An equal number of boys and girls will be selected from each class to enable gender
      analysis. Schoolteachers will assist in identifying and contacting all randomly-selected
      children and their mothers at household level. In the case of a school child who is randomly
      selected but is not present at the school due to illness, dropout etc., the subsequent child
      on class list will be selected. Children whose cognitive abilities are are challenged by
      autism, mental issues or iodine deficiency will be excluded from the study.

      Assuming a mean weight of 22.4 kg (SD=3.0 kg); and SFP is expected to increase the mean
      weight from 22.4 kg to 24.0 kg, thus to detect a difference of 1.6 kg with 90% power and type
      I error=0.05, design effect=2.0 and 10% drop-outs, the necessary sample-size calculated to be
      at least 164 school children in each group. This is less than the sample size required for
      BMI.

      For collection of blood and urine sample we will first randomly select a school from the
      upazila school list. Than again randomization will be performed for selection of children for
      specimen collection from the study participating children of that school.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from Baseline Children's weight at 14 months
time frame: Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)
description: Children's weight were measured by WHO
measure: Change from Baseline Children's Height at 14 months
time frame: Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)
description: Children's Height were measured by WHO
measure: Change from Baseline Children's nutritional impact at 14 months
time frame: Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)
description: Child anaemia and micronutrient deficiency: biochemical analyses of blood specimens
measure: Change from Baseline Children's cognitive performance and school attendance at 14 months
time frame: Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)
description: Subjective assessment of child sleepiness/attentiveness/concentration/irritability
arm group label: 2
arm group type: Active Comparator
description: The baseline study will be conducted using a cluster randomized study design in which schools represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10 that have been selected for intervention. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium. Children whose cognitive abilities are are challenged by autism, mental issues or iodine deficiency will be excluded from the study.
arm group label: Non Intervention
arm group type: Other
description: A control group will be included in study design consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated for inclusion in the feeding programme. Use of a control group will enable later evaluations to attribute possible improvements in key impact/outcome variables to the intervention itself. An equal number of boys and girls will be selected from each class to enable gender analysis. Children whose cognitive abilities are are challenged by autism, mental issues or iodine deficiency will be excluded from the study.No intervention had given in this group.
intervention type: Dietary Supplement
intervention name: The school feeding intervention
description: The baseline study will be conducted using a cluster randomized study design in which schools represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10 that have been selected for intervention. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium.
arm group label: 2
arm group label: Non Intervention
criteria: 
gender: All
minimum age: 5 Years
maximum age: 11 Years
healthy volunteers: No
citation: Powell CA, Walker SP, Chang SM, Grantham-McGregor SM. Nutrition and education: a randomized trial of the effects of breakfast in rural primary school children. Am J Clin Nutr. 1998 Oct;68(4):873-9. doi: 10.1093/ajcn/68.4.873.
PMID: 9771865
citation: Simeon DT. School feeding in Jamaica: a review of its evaluation. Am J Clin Nutr. 1998 Apr;67(4):790S-794S. doi: 10.1093/ajcn/67.4.790S.
PMID: 9537630
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No