xml: <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/NCT06009198</url>
    </required_header>
    <id_info>
      <org_study_id>: 2021-3572-19378</org_study_id>
      <nct_id>NCT06009198</nct_id>
    </id_info>
    <brief_title>Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan</brief_title>
    <official_title>Nutritional, Water, Sanitation and Hygiene Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan: A School Based Study: Protocol</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>
        Globally, one of the major risk factor for adolescent's morbidity is considered Malnutrition.&#xD;
        Worldwide adolescent age group 10-19 is increasing and they are at increased risk of&#xD;
        malnutrition related diseases resulting in high morbidity and mortality. Asian countries are&#xD;
        suffering with the double burden of malnutrition including Pakistan. The risk factors that&#xD;
        contribute to malnutrition in the population includes unsafe drinking water, poor sanitary&#xD;
        conditions, lack of proper waste disposal facilities, poor health awareness, poor nutrition&#xD;
        and hygiene. However, studies have shown that nutrition education, and water, sanitation,&#xD;
        hygiene (WASH) programmes in the schools are effective strategies to promote the health&#xD;
        status of the adolescents (girls and boys). The primary objective of this study is to&#xD;
        determine a school based nutrition and WASH education intervention to improve nutritional&#xD;
        status among early adolescents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a Cluster Randomized Control Trial. Two stage sampling technique will be done.&#xD;
        The sample size was calculated by using PASS software. Sample sizes was estimated to change&#xD;
        in nutritional status of the early adolescent boys and girls. Sample size of 360 adolescents&#xD;
        (180 in each intervention and control group) will achieve 80% power assuming 42% malnutrition&#xD;
        among students in control arm and at least 6% reduction in the intervention arm having 90&#xD;
        students from each school at a two-sided 5% level of significance.&#xD;
  &#xD;
        To assess the micronutrient levels (Iron, Zinc, Calcium, Complete Blood Count ) through blood&#xD;
        sample, a subset of 108 adolescents 6-8 grade school going adolescents (54 intervention&#xD;
        group,54 control group) from this total sample size (360) will be selected through random&#xD;
        selection.&#xD;
  &#xD;
        Data will be collected through adopted and adapted self-administered, structured&#xD;
        questionnaire from 6,7, and 8 grade school going adolescents at base line and at end line.&#xD;
  &#xD;
        To approach to 6, 7, and 8 grade adolescents, informed consent will be first taken from their&#xD;
        mothers/immediate caretaker and school management. Before collecting the data, a written&#xD;
        informed assent will also be taken from the participants available in Urdu and . Study&#xD;
        participants will be briefed about purpose of the study and assured about anonymity and&#xD;
        confidentiality of information shared. Finally, the survey questionnaire will be completed .&#xD;
        In case, participants have any queries related to the questionnaire, explanation will be&#xD;
        provided to them. Physical assessment will be done by the principal investigator which will&#xD;
        take almost 10 minutes/ individual. For the biochemical markers assistance from local Aga&#xD;
        Khan Laboratory will be sought. Phlebotomist /lab assistance from Aga Khan laboratory will go&#xD;
        to the concerned educational institute and draw blood samples from the participants who have&#xD;
        given their consent for the test.&#xD;
  &#xD;
        Data analysis plan Quantitative variables will be described by means and standard deviations&#xD;
        whereas median with interquartile range will be mentioned for qualitative variables.&#xD;
        Frequencies and percentages will be calculated for knowledge, attitude and practices of&#xD;
        adolescents regarding nutrition and WASH. The comparison between intervention and control at&#xD;
        base line and end line will be performed by using paired t-test and Chi-square. For the&#xD;
        variables that are not normally distributed, nonparametric test McNamara will be used. Binary&#xD;
        logistic regression and multiple linear regression will be used to assess the effect of&#xD;
        intervention. All the statistical analysis will be conducted using SPSS version 23. P value&#xD;
        less than 0.05 will be considered statistically significant.&#xD;
  &#xD;
        Intervention will be planned on the basis of socio ecological model and health promoting&#xD;
        school framework. School health environment, health education, health services and nutrition&#xD;
        programs will be focused in the intervention stage of the study .&#xD;
  &#xD;
        Sixteen sessions (one session per week) will be arranged on nutrition education and water,&#xD;
        sanitation, and hygiene for adolescents. Micronutrient tablets will be administered to the&#xD;
        adolescents for three months on daily basis through school teachers. In addition, Cooking&#xD;
        recipe in local language will be shared with adolescent's mother/immediate care takers&#xD;
        through adolescents.&#xD;
  &#xD;
        During the intervention phase, there is no such risks involve to the study participants&#xD;
        except their valuable time. Due to micronutrient supplementation there may be temporary&#xD;
        dizziness,nausea,headache, constipation, and dark color stool along with discomfort from&#xD;
        prick for blood drawing from adolescents. To reduce the temporary side effects of&#xD;
        administration of micronutrients , researcher will advise them to keep adequately hydrated&#xD;
        themselves and take the micronutrients supplementation tablet during meal. Reassurance&#xD;
        regarding drawing the blood samples will be done. Existing referral system will be identified&#xD;
        and utilized if needed Study Approval will be obtained from the Aga khan University Ethical&#xD;
        Review Committee (ERC). Approval will also be sort from the participating school management&#xD;
        in Gojra. Any identification information like name and personnel information will be replaced&#xD;
        by codes to address anonymity issue. Confidentiality of the data will be ensured by keeping&#xD;
        the data under safe custody, electronic files will also be password protected. Only the&#xD;
        primary investigator will access the raw data and the research team members involved in data&#xD;
        analysis. Respect for human dignity will be safeguarded by completely informing the&#xD;
        participants about all aspects of the study including purpose, their rights including right&#xD;
        to withdraw from the study at any point, and all possible risks and benefits. This&#xD;
        information will be communicated verbally as well as in writing in the form of consent&#xD;
        /assent. For the adolescent's participation, assent will be obtained after taking permission&#xD;
        from their parents / immediate caretaker.&#xD;
  &#xD;
        Trial will be conducted in compliance with the protocol, Good Clinical Practice and the&#xD;
        applicable regulatory requirement(s).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 30, 2021</start_date>
    <completion_date type="Actual">May 30, 2022</completion_date>
    <primary_completion_date type="Actual">March 15, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Knowledge regarding nutrition and WASH</measure>
      <time_frame>16 weeks</time_frame>
      <description>knowledge of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. It is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm&#xD;
  The knowledge part comprises 16 questions, each question with multiple options to assess the knowledge regarding food items, their consumption, and their effect on the health of adolescents. The knowledge will be assessed before and after intervention for comparison.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attitude regarding nutrition and WASH</measure>
      <time_frame>16 weeks</time_frame>
      <description>Attitude of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related knowledge, attitudes and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The attitude part covers 5 questions to know the perceived benefits and perceived barriers regarding food consumption before and after the intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Practices regarding nutrition and WASH</measure>
      <time_frame>16 weeks</time_frame>
      <description>Practices of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and Practices (2014), also called the KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The practices part contains 11 questions that address the practices regarding the consumption of food and behaviors. Pre and Post-intervention assessment of practices will evaluate the efficacy of the education sessions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>16 weeks</time_frame>
      <description>According to the Centre for Disease Control, guidelines will be followed to calculate Body Mass Index. Initially, the height and weight of all participants will be measured. the BMI will be calculated on the age parameter. This will help in determining a person's health on the basis of being Underweight, normal, Overweight, and obese. The criteria are as follow:&#xD;
  BMI Categories:&#xD;
  Underweight = &lt;18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Changes in Symptoms of malnutrition and micronutrient status</measure>
      <time_frame>16 weeks</time_frame>
      <description>A complete blood picture and blood level of calcium and Zinc will be measured prior to the intervention to gather baseline data. the blood test will be repeated 04 weeks after the intervention implementation. The changes in level will be compared and analyzed.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">635</enrollment>
    <condition>Malnutrition</condition>
    <arm_group>
      <arm_group_label>Advance Education with Iron Folate Supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nutrition education&#xD;
  WASH education&#xD;
  Micronutrient supplementation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine Education</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine school education</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Iron folate tablets</intervention_name>
      <description>Iron folate tablets will be administered to the underweight school going adolescents girls and boys to see the affect on BMI and micronutrients</description>
      <arm_group_label>Advance Education with Iron Folate Supplement</arm_group_label>
      <other_name>Nutrition and WASH education</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All students studying in 6, 7, and 8 grade&#xD;
  &#xD;
            -  Informed consent given by adolescent's mothers/immediate care takers&#xD;
  &#xD;
            -  Assent given by the adolescent at baseline&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Students leave the school during study • Consent not given by the mother/immediate&#xD;
               care taker will be excluded from the analysis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rozina Karmaliani, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aga Khan University school of Nursing and Midwifery karachi,pakistan</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Aga Khan University karachi,pakistan</name>
        <address>
          <city>Karachi</city>
          <state>Sind</state>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 16, 2022</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aga Khan University</investigator_affiliation>
      <investigator_full_name>Dr Rozina Karmaliani</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <keyword>Adolescents</keyword>
    <keyword>Nutrition</keyword>
    <keyword>School</keyword>
    <keyword>Body Mass Index</keyword>
    <keyword>WASH</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>
      <ipd_description>The data is shared on the whole through publication. The individual data will not be shared with any researcher The study findings will also shared with stake holders</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT06009198/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009198
  org study id: : 2021-3572-19378
  nct id: NCT06009198
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Globally, one of the major risk factor for adolescent's morbidity is considered Malnutrition.
        Worldwide adolescent age group 10-19 is increasing and they are at increased risk of
        malnutrition related diseases resulting in high morbidity and mortality. Asian countries are
        suffering with the double burden of malnutrition including Pakistan. The risk factors that
        contribute to malnutrition in the population includes unsafe drinking water, poor sanitary
        conditions, lack of proper waste disposal facilities, poor health awareness, poor nutrition
        and hygiene. However, studies have shown that nutrition education, and water, sanitation,
        hygiene (WASH) programmes in the schools are effective strategies to promote the health
        status of the adolescents (girls and boys). The primary objective of this study is to
        determine a school based nutrition and WASH education intervention to improve nutritional
        status among early adolescents.
  This study is a Cluster Randomized Control Trial. Two stage sampling technique will be done.
        The sample size was calculated by using PASS software. Sample sizes was estimated to change
        in nutritional status of the early adolescent boys and girls. Sample size of 360 adolescents
        (180 in each intervention and control group) will achieve 80% power assuming 42% malnutrition
        among students in control arm and at least 6% reduction in the intervention arm having 90
        students from each school at a two-sided 5% level of significance.
  
        To assess the micronutrient levels (Iron, Zinc, Calcium, Complete Blood Count ) through blood
        sample, a subset of 108 adolescents 6-8 grade school going adolescents (54 intervention
        group,54 control group) from this total sample size (360) will be selected through random
        selection.
  
        Data will be collected through adopted and adapted self-administered, structured
        questionnaire from 6,7, and 8 grade school going adolescents at base line and at end line.
  
        To approach to 6, 7, and 8 grade adolescents, informed consent will be first taken from their
        mothers/immediate caretaker and school management. Before collecting the data, a written
        informed assent will also be taken from the participants available in Urdu and . Study
        participants will be briefed about purpose of the study and assured about anonymity and
        confidentiality of information shared. Finally, the survey questionnaire will be completed .
        In case, participants have any queries related to the questionnaire, explanation will be
        provided to them. Physical assessment will be done by the principal investigator which will
        take almost 10 minutes/ individual. For the biochemical markers assistance from local Aga
        Khan Laboratory will be sought. Phlebotomist /lab assistance from Aga Khan laboratory will go
        to the concerned educational institute and draw blood samples from the participants who have
        given their consent for the test.
  
        Data analysis plan Quantitative variables will be described by means and standard deviations
        whereas median with interquartile range will be mentioned for qualitative variables.
        Frequencies and percentages will be calculated for knowledge, attitude and practices of
        adolescents regarding nutrition and WASH. The comparison between intervention and control at
        base line and end line will be performed by using paired t-test and Chi-square. For the
        variables that are not normally distributed, nonparametric test McNamara will be used. Binary
        logistic regression and multiple linear regression will be used to assess the effect of
        intervention. All the statistical analysis will be conducted using SPSS version 23. P value
        less than 0.05 will be considered statistically significant.
  
        Intervention will be planned on the basis of socio ecological model and health promoting
        school framework. School health environment, health education, health services and nutrition
        programs will be focused in the intervention stage of the study .
  
        Sixteen sessions (one session per week) will be arranged on nutrition education and water,
        sanitation, and hygiene for adolescents. Micronutrient tablets will be administered to the
        adolescents for three months on daily basis through school teachers. In addition, Cooking
        recipe in local language will be shared with adolescent's mother/immediate care takers
        through adolescents.
  
        During the intervention phase, there is no such risks involve to the study participants
        except their valuable time. Due to micronutrient supplementation there may be temporary
        dizziness,nausea,headache, constipation, and dark color stool along with discomfort from
        prick for blood drawing from adolescents. To reduce the temporary side effects of
        administration of micronutrients , researcher will advise them to keep adequately hydrated
        themselves and take the micronutrients supplementation tablet during meal. Reassurance
        regarding drawing the blood samples will be done. Existing referral system will be identified
        and utilized if needed Study Approval will be obtained from the Aga khan University Ethical
        Review Committee (ERC). Approval will also be sort from the participating school management
        in Gojra. Any identification information like name and personnel information will be replaced
        by codes to address anonymity issue. Confidentiality of the data will be ensured by keeping
        the data under safe custody, electronic files will also be password protected. Only the
        primary investigator will access the raw data and the research team members involved in data
        analysis. Respect for human dignity will be safeguarded by completely informing the
        participants about all aspects of the study including purpose, their rights including right
        to withdraw from the study at any point, and all possible risks and benefits. This
        information will be communicated verbally as well as in writing in the form of consent
        /assent. For the adolescent's participation, assent will be obtained after taking permission
        from their parents / immediate caretaker.
  
        Trial will be conducted in compliance with the protocol, Good Clinical Practice and the
        applicable regulatory requirement(s).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Knowledge regarding nutrition and WASH
  time frame: 16 weeks
  description: knowledge of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. It is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm
  The knowledge part comprises 16 questions, each question with multiple options to assess the knowledge regarding food items, their consumption, and their effect on the health of adolescents. The knowledge will be assessed before and after intervention for comparison.
  measure: Attitude regarding nutrition and WASH
  time frame: 16 weeks
  description: Attitude of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related knowledge, attitudes and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The attitude part covers 5 questions to know the perceived benefits and perceived barriers regarding food consumption before and after the intervention
  measure: Practices regarding nutrition and WASH
  time frame: 16 weeks
  description: Practices of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and Practices (2014), also called the KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The practices part contains 11 questions that address the practices regarding the consumption of food and behaviors. Pre and Post-intervention assessment of practices will evaluate the efficacy of the education sessions.
  measure: Body Mass Index
  time frame: 16 weeks
  description: According to the Centre for Disease Control, guidelines will be followed to calculate Body Mass Index. Initially, the height and weight of all participants will be measured. the BMI will be calculated on the age parameter. This will help in determining a person's health on the basis of being Underweight, normal, Overweight, and obese. The criteria are as follow:
  BMI Categories:
  Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater
  measure: Changes in Symptoms of malnutrition and micronutrient status
  time frame: 16 weeks
  description: A complete blood picture and blood level of calcium and Zinc will be measured prior to the intervention to gather baseline data. the blood test will be repeated 04 weeks after the intervention implementation. The changes in level will be compared and analyzed.
  arm group label: Advance Education with Iron Folate Supplement
  arm group type: Experimental
  description: Nutrition education
  WASH education
  Micronutrient supplementation
  arm group label: Routine Education
  arm group type: No Intervention
  description: Routine school education
  intervention type: Drug
  intervention name: Iron folate tablets
  description: Iron folate tablets will be administered to the underweight school going adolescents girls and boys to see the affect on BMI and micronutrients
  arm group label: Advance Education with Iron Folate Supplement
  other name: Nutrition and WASH education
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Rozina Karmaliani, Dr
  role: Principal Investigator
  affiliation: Aga Khan University school of Nursing and Midwifery karachi,pakistan
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Aga Khan University
  investigator full name: Dr Rozina Karmaliani
  investigator title: Dr
  mesh term: Malnutrition
  sharing ipd: No
  ipd description: The data is shared on the whole through publication. The individual data will not be shared with any researcher The study findings will also shared with stake holders
  provided document: 