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/NCT06018636</url>
    </required_header>
    <id_info>
      <org_study_id>Nutrition &amp; Child Development</org_study_id>
      <nct_id>NCT06018636</nct_id>
    </id_info>
    <brief_title>Impact of Diet and Nutrition on Growth and Development in Young Children</brief_title>
    <acronym>DIGEST</acronym>
    <official_title>Dietary Intake/Patterns, Nutritional Status and Their Association With Growth and Development of Children From Remote, Agropastoral Communities of District Swat, Pakistan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Khyber Medical University Peshawar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Chester</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Khyber Medical University Peshawar</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>
        The association between nutrition in early life and its long-term health consequences has&#xD;
        long been known. However, there is a scarcity of scientific evidence on how nutritional&#xD;
        status affects child growth and development in remote, rural agro-pastoral communities with&#xD;
        distinct dietary intake habits, geographical location, socio-economic status, and cultures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Childhood malnutrition is endemic in Pakistan. However, the agro-pastoral communities of&#xD;
        Pakistan are at particularly high risk of childhood malnutrition due to low socioeconomic&#xD;
        status, hard-to-reach geographic locations, harsh weather, and frequent natural disasters due&#xD;
        to rapid climate change. Furthermore, distinct dietary habits and cultures may also influence&#xD;
        child nutritional status and health and development in these communities. The present study&#xD;
        aims to assess the dietary intake/patterns, nutritional status, and their association with&#xD;
        the growth and development of children from remote, agro-pastoral communities of District&#xD;
        Swat, Pakistan.&#xD;
  &#xD;
        In this prospective cohort study from Pakistan, infants and young children (n=416) aged ≤ 2&#xD;
        years and residing in agro-pastoral communities of District Swat will be recruited and&#xD;
        followed every 12 months for 5 years. An age and gender-matched comparison group of children&#xD;
        (n=416) will also be recruited from the more urban areas of District Swat. Data on household&#xD;
        socio-economic status, Household Food Insecurity Access Scale (HFIAS), Minimum Dietary&#xD;
        Diversity (MDD) of Mothers, Infant and young child feeding practices (IYCF), Complimentary&#xD;
        Feeding and Eating practices, and growth and development of the children will be assessed&#xD;
        from baseline and every 12 months till the child is 5 years old. Anthropometric assessment&#xD;
        including height, weight, mid-upper arm circumference (MUAC), and BMI will also be performed&#xD;
        at each time point.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 28, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Impact of dietary intake/patterns on Child growth as assessed by body mass index (BMI)</measure>
      <time_frame>5 years</time_frame>
      <description>Child growth will be assessed through changes in Body Mass Index (BMI) from baseline and each year till the child is 5 years of age. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. These data will be categorised further on the basis of the dietary intake patterns of the children as assessed by Infant and Young child feeding practices (IYCF) questionnaire.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of dietary intake/patterns on Child development</measure>
      <time_frame>5 years</time_frame>
      <description>Assessment of child development from baseline and each year till the child is 5 years of age. Child development will be assessed by changes in Head circumference and a validated questionnaire (Extended Ages and Stages Questionnaire-3). The EASQ-3 contains 21 questions, targeting child's Communication, Gross motor, Fine motor, Problem solving and Personal-Social skills, each having a total score of 0-60 and cut-off value at 22.77, 41.84, 30.16, 24.62 and 33.71, respectively. Score below the cut-off value indicates possible developmental delays while score slightly above the cut-off value indicates further learning activities and monitoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Factors associated with child growth as assessed by changes in BMI</measure>
      <time_frame>5 years</time_frame>
      <description>The relationship between child growth and socio-demographic characteristics of the parents, household food insecurity, mother dietary intake (minimum dietary diversity score), and childhood trauma (assessed through Childhood Trauma Scale). CTS is a validated questionnaire containing 16 questions on 04 different aspects trauma i.e., Physical Neglect, Physical Abuse, Emotional Neglect and Emotional Abuse. Total score ranges from 0-80 while 0-20 for each section. Each section has four different cut-off values indicating None, Low, Moderate or Severe neglect/abuse.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Factors associated with child development (based on Head circumference and EASQ-3)</measure>
      <time_frame>5 years</time_frame>
      <description>The relationship between child development and socio-demographic characteristics of the parents, household food insecurity, mother dietary intake (minimum dietary diversity score), and childhood trauma (assessed through Childhood Trauma Scale).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">832</enrollment>
    <condition>Nutrition</condition>
    <condition>Growth</condition>
    <condition>Development</condition>
    <condition>Stunting</condition>
    <condition>Wasting</condition>
    <condition>Obesity</condition>
    <condition>Child Development</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Infants and young children residing in agropastoral communities of District Swat, Pakistan</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Infant and young children residing in urban areas of district Swat, Pakistan</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The target population (infants and young children) residing either in rural, agro-pastoral&#xD;
          communities or urban clusters will be recruited from the respective communities. A list of&#xD;
          potential participants will be obtained from Extended Program on Immunization (EPI) data of&#xD;
          available with local health facilities (Basic Health Unit).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Households living in the area from the last two 2 years.&#xD;
  &#xD;
            -  Households having infants or young children ≤ years.&#xD;
  &#xD;
            -  Households planning to reside in the same area for the next 1 year.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with any co-existent systemic diseases, confirmed from medical records.&#xD;
  &#xD;
            -  Children on continuous medications for any medical issue.&#xD;
  &#xD;
            -  Physically or mentally handicapped children&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>24 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Muhammad Shahzad, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Khyber Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Muhammad Shahzad, PhD</last_name>
      <phone>00923459048796</phone>
      <email>shahzad.ibms@kmu.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahsan Saidal, MHR</last_name>
      <phone>00923348294105</phone>
      <email>ahsan.ipms@kmu.edu.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dr. Muhammad Shahzad</name>
        <address>
          <city>Swat</city>
          <state>Khyber Pakhtunkhwa</state>
          <zip>19040</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Muhammad Shahzad, PhD</last_name>
        <phone>00923459048796</phone>
        <email>shahzad.ibms@kmu.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Ahsan Saidal, MHR</last_name>
        <phone>00923348294105</phone>
        <email>ahsan.ipms@kmu.edu.pk</email>
      </contact_backup>
      <investigator>
        <last_name>Ahsan Saidal, MHR</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.</citation>
      <PMID>12035858</PMID>
    </reference>
    <reference>
      <citation>Roth DE, Krishna A, Leung M, Shi J, Bassani DG, Barros AJD. Early childhood linear growth faltering in low-income and middle-income countries as a whole-population condition: analysis of 179 Demographic and Health Surveys from 64 countries (1993-2015). Lancet Glob Health. 2017 Dec;5(12):e1249-e1257. doi: 10.1016/S2214-109X(17)30418-7.</citation>
      <PMID>29132614</PMID>
    </reference>
    <reference>
      <citation>Lee A, Cheung CK, Lo K, Keung VM, Mui LW, Tam WWS. Studying Impact of Nutrition on Growth (SING): a prospective cohort for comparing the health outcomes of young children with the dietary quality score. BMJ Open. 2017 Nov 8;7(11):e018380. doi: 10.1136/bmjopen-2017-018380.</citation>
      <PMID>29122800</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nutritional status</keyword>
    <keyword>Malnutrition</keyword>
    <keyword>Growth</keyword>
    <keyword>Cognitive Development</keyword>
    <keyword>Anthropometry</keyword>
    <keyword>Agropastoral</keyword>
    <keyword>remote</keyword>
    <keyword>rural</keyword>
    <keyword>Urban</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Growth Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06018636
  org study id: Nutrition & Child Development
  nct id: NCT06018636
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The association between nutrition in early life and its long-term health consequences has
        long been known. However, there is a scarcity of scientific evidence on how nutritional
        status affects child growth and development in remote, rural agro-pastoral communities with
        distinct dietary intake habits, geographical location, socio-economic status, and cultures.
  Childhood malnutrition is endemic in Pakistan. However, the agro-pastoral communities of
        Pakistan are at particularly high risk of childhood malnutrition due to low socioeconomic
        status, hard-to-reach geographic locations, harsh weather, and frequent natural disasters due
        to rapid climate change. Furthermore, distinct dietary habits and cultures may also influence
        child nutritional status and health and development in these communities. The present study
        aims to assess the dietary intake/patterns, nutritional status, and their association with
        the growth and development of children from remote, agro-pastoral communities of District
        Swat, Pakistan.
  
        In this prospective cohort study from Pakistan, infants and young children (n=416) aged ≤ 2
        years and residing in agro-pastoral communities of District Swat will be recruited and
        followed every 12 months for 5 years. An age and gender-matched comparison group of children
        (n=416) will also be recruited from the more urban areas of District Swat. Data on household
        socio-economic status, Household Food Insecurity Access Scale (HFIAS), Minimum Dietary
        Diversity (MDD) of Mothers, Infant and young child feeding practices (IYCF), Complimentary
        Feeding and Eating practices, and growth and development of the children will be assessed
        from baseline and every 12 months till the child is 5 years old. Anthropometric assessment
        including height, weight, mid-upper arm circumference (MUAC), and BMI will also be performed
        at each time point.
  observational model: Cohort
  time perspective: Prospective
  measure: Impact of dietary intake/patterns on Child growth as assessed by body mass index (BMI)
  time frame: 5 years
  description: Child growth will be assessed through changes in Body Mass Index (BMI) from baseline and each year till the child is 5 years of age. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. These data will be categorised further on the basis of the dietary intake patterns of the children as assessed by Infant and Young child feeding practices (IYCF) questionnaire.
  measure: Impact of dietary intake/patterns on Child development
  time frame: 5 years
  description: Assessment of child development from baseline and each year till the child is 5 years of age. Child development will be assessed by changes in Head circumference and a validated questionnaire (Extended Ages and Stages Questionnaire-3). The EASQ-3 contains 21 questions, targeting child's Communication, Gross motor, Fine motor, Problem solving and Personal-Social skills, each having a total score of 0-60 and cut-off value at 22.77, 41.84, 30.16, 24.62 and 33.71, respectively. Score below the cut-off value indicates possible developmental delays while score slightly above the cut-off value indicates further learning activities and monitoring.
  measure: Factors associated with child growth as assessed by changes in BMI
  time frame: 5 years
  description: The relationship between child growth and socio-demographic characteristics of the parents, household food insecurity, mother dietary intake (minimum dietary diversity score), and childhood trauma (assessed through Childhood Trauma Scale). CTS is a validated questionnaire containing 16 questions on 04 different aspects trauma i.e., Physical Neglect, Physical Abuse, Emotional Neglect and Emotional Abuse. Total score ranges from 0-80 while 0-20 for each section. Each section has four different cut-off values indicating None, Low, Moderate or Severe neglect/abuse.
  measure: Factors associated with child development (based on Head circumference and EASQ-3)
  time frame: 5 years
  description: The relationship between child development and socio-demographic characteristics of the parents, household food insecurity, mother dietary intake (minimum dietary diversity score), and childhood trauma (assessed through Childhood Trauma Scale).
  arm group label: Group 1
  description: Infants and young children residing in agropastoral communities of District Swat, Pakistan
  arm group label: Group 2
  description: Infant and young children residing in urban areas of district Swat, Pakistan
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 24 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Muhammad Shahzad, PhD
  role: Principal Investigator
  affiliation: Khyber Medical University
  last name: Muhammad Shahzad, PhD
  phone: 00923459048796
  email: shahzad.ibms@kmu.edu.pk
  last name: Ahsan Saidal, MHR
  phone: 00923348294105
  email: ahsan.ipms@kmu.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  citation: Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.
  PMID: 12035858
  citation: Roth DE, Krishna A, Leung M, Shi J, Bassani DG, Barros AJD. Early childhood linear growth faltering in low-income and middle-income countries as a whole-population condition: analysis of 179 Demographic and Health Surveys from 64 countries (1993-2015). Lancet Glob Health. 2017 Dec;5(12):e1249-e1257. doi: 10.1016/S2214-109X(17)30418-7.
  PMID: 29132614
  citation: Lee A, Cheung CK, Lo K, Keung VM, Mui LW, Tam WWS. Studying Impact of Nutrition on Growth (SING): a prospective cohort for comparing the health outcomes of young children with the dietary quality score. BMJ Open. 2017 Nov 8;7(11):e018380. doi: 10.1136/bmjopen-2017-018380.
  PMID: 29122800
  responsible party type: Sponsor
  mesh term: Growth Disorders
  sharing ipd: No