<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/NCT04447209</url>
  </required_header>
  <id_info>
    <org_study_id>2020410-8500</org_study_id>
    <nct_id>NCT04447209</nct_id>
  </id_info>
  <brief_title>Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study</brief_title>
  <acronym>CoDDYC</acronym>
  <official_title>Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</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 2019-2020 coronavirus pandemic has had far-reaching consequences beyond the spread of the&#xD;
      disease. Quarantine measures during a public health pandemic can be particularly detrimental&#xD;
      to urban poor families and affect the dietary diversity and food security. This can&#xD;
      disproportionately affect young children aged 6 and below, and severely impact those &lt;2&#xD;
      years. Sudden unemployment may result in an unexpected reduction in income that will place&#xD;
      pressure on daily budgets for food. Children of families may not have access to foods of&#xD;
      adequate diversity that will enable them to meet their macro and micronutrient requirements&#xD;
      for growth and development, especially during the Movement Control Order (MCO). The study&#xD;
      plans to monitor and evaluate dietary diversity in young children's food intake after the MCO&#xD;
      and use the collected information to direct targeted food aid to address observed macro- and&#xD;
      micronutrient deficiencies among the urban vulnerable group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children are the future to our society. The first thousand days of life, starting from&#xD;
      conception till one's second birthday is a critical period of cognitive and physical&#xD;
      development. It is the most sensitive period where brain development is most receptive to&#xD;
      positive nutrition. Any form of malnutrition, especially during this golden time frame, can&#xD;
      lead to irreversible effects to growth, health, education and future career attainment to our&#xD;
      potential leaders, which in turn can be a barrier to human development.&#xD;
&#xD;
      The CoVID outbreak is a unique period in recent human history where drastic public health&#xD;
      measures such as MCO for an extended period of time has to be implemented nation-wide. These&#xD;
      measures have untold severe consequences on the food security of the vulnerable urban group,&#xD;
      in particular the young children whose brains require diverse micronutrients to support the&#xD;
      rapid growth. These micronutrients can only be obtained from a daily diet that is equally&#xD;
      diverse, especially from fresh vegetables and fruits which will be short in supplies. These&#xD;
      perishable food items are not usually included in food aids, thus the child may have to&#xD;
      subsist on staple-rich diet which are energy-dense but nutrient-poor. These dietary practices&#xD;
      are associated with negative health outcomes. Thus by monitoring dietary diversity of the&#xD;
      children, we hope to better inform food aid organisations to consider the inclusion of&#xD;
      healthier food options to prevent micronutrient deficiencies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of food groups in 24 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>4 months</time_frame>
    <description>Height increase in centimetres</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>4 months</time_frame>
    <description>Weight increase in kilogram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Meal frequencies in past 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of meal frequencies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood hemoglobin in children at the start of study and 4 months later</measure>
    <time_frame>4 months</time_frame>
    <description>Change in gram/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum ferritin in children at the start of study and 4 months later</measure>
    <time_frame>4 months</time_frame>
    <description>Change in microgram/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of sugar and processed foods</measure>
    <time_frame>1 month</time_frame>
    <description>Number of types</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Aids received</measure>
    <time_frame>1 month</time_frame>
    <description>Types of food groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">469</enrollment>
  <condition>Dietary Diversity</condition>
  <arm_group>
    <arm_group_label>Child Health Clinic (CHC)</arm_group_label>
    <description>Children attending CHC for routine vaccinations and follow-up in a tertiary center Parents will be counselled on food groups based on Infant and Young Children feeding practices.&#xD;
Monthly telephone calls to collect data on dietary diversity - 4 telephone calls in total.&#xD;
Anthropometric measurements and Blood investigations for hemoglobin and iron status at the start and end of study - optional</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Children</arm_group_label>
    <description>Children of urban poor families living in low-cost flats around Kuala Lumpur. Parents will be counselled on food groups based on Infant and Young Children feeding practices.&#xD;
Monthly telephone calls to collect data on dietary diversity - 4 telephone calls in total.&#xD;
Anthropometric measurements and Blood investigations for hemoglobin and iron status at the start and end of study - optional</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary counselling on Food Groups according to IYC Feeding practices, WHO</intervention_name>
    <description>Monitoring of Dietary diversity and growth</description>
    <arm_group_label>Child Health Clinic (CHC)</arm_group_label>
    <arm_group_label>Community Children</arm_group_label>
    <other_name>Monthly telephone calls to collect data on dietary diversity - 4 telephone calls in total.</other_name>
    <other_name>Anthropometric measurements and Blood investigations for hemoglobin and iron status (optional)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children who participated in the Children of Urban Poverty Iron Project (CUPIP), PPR Lembah&#xD;
        Subang 1, Selangor&#xD;
&#xD;
        Children in PPR Kota Damansara, Selangor&#xD;
&#xD;
        Children who attend the Child Health Clinic, UMMC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All well-children aged between 6 months and 6 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with chronic illnesses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Y Jalaludin, MBBS MPaeds</last_name>
    <role>Study Director</role>
    <affiliation>University of Malaya Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Malaya Medical Center</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan Kuala Lumpur</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008</citation>
  </reference>
  <reference>
    <citation>Working Group on Infant and Young Child Feeding Indicators. Developing and validating simple indicators of dietary quality of infants and young children in developing countries: Additional analysis of 10 data sets. Report submitted to: the Food and Nutrition Technical Assistance (FANTA) Project/Academy for Educational Development (AED), July 2007</citation>
  </reference>
  <reference>
    <citation>Kennedy GL, Pedro MR, Seghieri C, Nantel G, Brouwer I. Dietary diversity score is a useful indicator of micronutrient intake in non-breast-feeding Filipino children. J Nutr. 2007 Feb;137(2):472-7. doi: 10.1093/jn/137.2.472.</citation>
    <PMID>17237329</PMID>
  </reference>
  <reference>
    <citation>Cusick SE, Georgieff MK. The Role of Nutrition in Brain Development: The Golden Opportunity of the &quot;First 1000 Days&quot;. J Pediatr. 2016 Aug;175:16-21. doi: 10.1016/j.jpeds.2016.05.013. Epub 2016 Jun 3. No abstract available.</citation>
    <PMID>27266965</PMID>
  </reference>
  <reference>
    <citation>Steyn NP, Nel JH, Nantel G, Kennedy G, Labadarios D. Food variety and dietary diversity scores in children: are they good indicators of dietary adequacy? Public Health Nutr. 2006 Aug;9(5):644-50. doi: 10.1079/phn2005912.</citation>
    <PMID>16923296</PMID>
  </reference>
  <reference>
    <citation>World Health Organization, Geneva. 2017; Global Nutritional Monitoring Framework: Operational guidance for tracking progress in meeting targets for 2025</citation>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Lucy Lum Chai See</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dietary diversity</keyword>
  <keyword>micro-nutrient adequacy</keyword>
  <keyword>young children</keyword>
  <keyword>urban settings</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chrysarobin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will share demographic data of subject and family, baseline anthropometric measurements as well as dietary diversity of children in various locales</ipd_description>
  </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/NCT04447209
org study id: 2020410-8500
nct id: NCT04447209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The 2019-2020 coronavirus pandemic has had far-reaching consequences beyond the spread of the
      disease. Quarantine measures during a public health pandemic can be particularly detrimental
      to urban poor families and affect the dietary diversity and food security. This can
      disproportionately affect young children aged 6 and below, and severely impact those <2
      years. Sudden unemployment may result in an unexpected reduction in income that will place
      pressure on daily budgets for food. Children of families may not have access to foods of
      adequate diversity that will enable them to meet their macro and micronutrient requirements
      for growth and development, especially during the Movement Control Order (MCO). The study
      plans to monitor and evaluate dietary diversity in young children's food intake after the MCO
      and use the collected information to direct targeted food aid to address observed macro- and
      micronutrient deficiencies among the urban vulnerable group.
Children are the future to our society. The first thousand days of life, starting from
      conception till one's second birthday is a critical period of cognitive and physical
      development. It is the most sensitive period where brain development is most receptive to
      positive nutrition. Any form of malnutrition, especially during this golden time frame, can
      lead to irreversible effects to growth, health, education and future career attainment to our
      potential leaders, which in turn can be a barrier to human development.

      The CoVID outbreak is a unique period in recent human history where drastic public health
      measures such as MCO for an extended period of time has to be implemented nation-wide. These
      measures have untold severe consequences on the food security of the vulnerable urban group,
      in particular the young children whose brains require diverse micronutrients to support the
      rapid growth. These micronutrients can only be obtained from a daily diet that is equally
      diverse, especially from fresh vegetables and fruits which will be short in supplies. These
      perishable food items are not usually included in food aids, thus the child may have to
      subsist on staple-rich diet which are energy-dense but nutrient-poor. These dietary practices
      are associated with negative health outcomes. Thus by monitoring dietary diversity of the
      children, we hope to better inform food aid organisations to consider the inclusion of
      healthier food options to prevent micronutrient deficiencies.
observational model: Cohort
time perspective: Prospective
measure: Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours
time frame: 24 hours
description: Number of food groups in 24 hours
measure: Height
time frame: 4 months
description: Height increase in centimetres
measure: Weight
time frame: 4 months
description: Weight increase in kilogram
measure: Meal frequencies in past 24 hours
time frame: 24 hours
description: Number of meal frequencies
measure: Blood hemoglobin in children at the start of study and 4 months later
time frame: 4 months
description: Change in gram/L
measure: Serum ferritin in children at the start of study and 4 months later
time frame: 4 months
description: Change in microgram/L
measure: Consumption of sugar and processed foods
time frame: 1 month
description: Number of types
measure: Food Aids received
time frame: 1 month
description: Types of food groups
arm group label: Child Health Clinic (CHC)
description: Children attending CHC for routine vaccinations and follow-up in a tertiary center Parents will be counselled on food groups based on Infant and Young Children feeding practices.
Monthly telephone calls to collect data on dietary diversity - 4 telephone calls in total.
Anthropometric measurements and Blood investigations for hemoglobin and iron status at the start and end of study - optional
arm group label: Community Children
description: Children of urban poor families living in low-cost flats around Kuala Lumpur. Parents will be counselled on food groups based on Infant and Young Children feeding practices.
Monthly telephone calls to collect data on dietary diversity - 4 telephone calls in total.
Anthropometric measurements and Blood investigations for hemoglobin and iron status at the start and end of study - optional
intervention type: Other
intervention name: Dietary counselling on Food Groups according to IYC Feeding practices, WHO
description: Monitoring of Dietary diversity and growth
arm group label: Child Health Clinic (CHC)
arm group label: Community Children
other name: Monthly telephone calls to collect data on dietary diversity - 4 telephone calls in total.
other name: Anthropometric measurements and Blood investigations for hemoglobin and iron status (optional)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohammad Y Jalaludin, MBBS MPaeds
role: Study Director
affiliation: University of Malaya Medical Center
facility: 
country: Malaysia
citation: World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008
citation: Working Group on Infant and Young Child Feeding Indicators. Developing and validating simple indicators of dietary quality of infants and young children in developing countries: Additional analysis of 10 data sets. Report submitted to: the Food and Nutrition Technical Assistance (FANTA) Project/Academy for Educational Development (AED), July 2007
citation: Kennedy GL, Pedro MR, Seghieri C, Nantel G, Brouwer I. Dietary diversity score is a useful indicator of micronutrient intake in non-breast-feeding Filipino children. J Nutr. 2007 Feb;137(2):472-7. doi: 10.1093/jn/137.2.472.
PMID: 17237329
citation: Cusick SE, Georgieff MK. The Role of Nutrition in Brain Development: The Golden Opportunity of the "First 1000 Days". J Pediatr. 2016 Aug;175:16-21. doi: 10.1016/j.jpeds.2016.05.013. Epub 2016 Jun 3. No abstract available.
PMID: 27266965
citation: Steyn NP, Nel JH, Nantel G, Kennedy G, Labadarios D. Food variety and dietary diversity scores in children: are they good indicators of dietary adequacy? Public Health Nutr. 2006 Aug;9(5):644-50. doi: 10.1079/phn2005912.
PMID: 16923296
citation: World Health Organization, Geneva. 2017; Global Nutritional Monitoring Framework: Operational guidance for tracking progress in meeting targets for 2025
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Lucy Lum Chai See
investigator title: Professor
mesh term: Chrysarobin
sharing ipd: No
ipd description: We will share demographic data of subject and family, baseline anthropometric measurements as well as dietary diversity of children in various locales