<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/NCT04461106</url>
  </required_header>
  <id_info>
    <org_study_id>202007077</org_study_id>
    <nct_id>NCT04461106</nct_id>
  </id_info>
  <brief_title>A New Measure of Egg Consumption and the Effect of Social Marketing Eggs</brief_title>
  <official_title>A Two-Phase Study to Investigate Novel Biomarkers of Egg Consumption and Social Marketing Effectiveness of Egg Hubs for Malawian Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Project Peanut Butter, Malawi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kamuzu University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>
      About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be&#xD;
      receive social marketing campaign to raise awareness about the benefits of eggs while the&#xD;
      other 4 will not receive social marketing campaign. Children will provide a urine sample for&#xD;
      analysis of metabolites to correlate with egg consumption.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2021</start_date>
  <completion_date type="Actual">September 10, 2022</completion_date>
  <primary_completion_date type="Actual">September 10, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of egg consumed daily</measure>
    <time_frame>12 Months</time_frame>
    <description>As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">815</enrollment>
  <condition>Nutritional Stunting</condition>
  <arm_group>
    <arm_group_label>Social Marketing Campaign</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Select egg hubs will receive social marketing campaign which aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (&lt;5yrs) and pregnant/lactating women.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Social Marketing Campaign</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Other egg hugs will not receive social marketing campaign.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Social Marketing Campaign</intervention_name>
    <description>aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (&lt;5yrs) and pregnant/lactating women</description>
    <arm_group_label>Social Marketing Campaign</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health children between 6 and 24 months of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute malnutrition&#xD;
&#xD;
          -  congenital abnormalities&#xD;
&#xD;
          -  chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Manary, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine in St. Louis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Project Peanut Butter</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <reference>
    <citation>Garcia-Perez I, Posma JM, Gibson R, Chambers ES, Hansen TH, Vestergaard H, Hansen T, Beckmann M, Pedersen O, Elliott P, Stamler J, Nicholson JK, Draper J, Mathers JC, Holmes E, Frost G. Objective assessment of dietary patterns by use of metabolic phenotyping: a randomised, controlled, crossover trial. Lancet Diabetes Endocrinol. 2017 Mar;5(3):184-195. doi: 10.1016/S2213-8587(16)30419-3. Epub 2017 Jan 13.</citation>
    <PMID>28089709</PMID>
  </reference>
  <reference>
    <citation>S C Sri Harsha P, Abdul Wahab R, Cuparencu C, Dragsted LO, Brennan L. A Metabolomics Approach to the Identification of Urinary Biomarkers of Pea Intake. Nutrients. 2018 Dec 4;10(12):1911. doi: 10.3390/nu10121911.</citation>
    <PMID>30518059</PMID>
  </reference>
  <reference>
    <citation>Koppmair S, Kassie M, Qaim M. Farm production, market access and dietary diversity in Malawi. Public Health Nutr. 2017 Feb;20(2):325-335. doi: 10.1017/S1368980016002135. Epub 2016 Sep 9.</citation>
    <PMID>27609557</PMID>
  </reference>
  <reference>
    <citation>Eaton JC, Rothpletz-Puglia P, Dreker MR, Iannotti L, Lutter C, Kaganda J, Rayco-Solon P. Effectiveness of provision of animal-source foods for supporting optimal growth and development in children 6 to 59 months of age. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD012818. doi: 10.1002/14651858.CD012818.pub2.</citation>
    <PMID>30779870</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Growth Disorders</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 10, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04461106/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04461106
org study id: 202007077
nct id: NCT04461106
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be
      receive social marketing campaign to raise awareness about the benefits of eggs while the
      other 4 will not receive social marketing campaign. Children will provide a urine sample for
      analysis of metabolites to correlate with egg consumption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Amount of egg consumed daily
time frame: 12 Months
description: As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study.
arm group label: Social Marketing Campaign
arm group type: Active Comparator
description: Select egg hubs will receive social marketing campaign which aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women.
arm group label: No Social Marketing Campaign
arm group type: No Intervention
description: Other egg hugs will not receive social marketing campaign.
intervention type: Other
intervention name: Social Marketing Campaign
description: aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women
arm group label: Social Marketing Campaign
criteria: 
gender: All
minimum age: 6 Months
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Manary, MD
role: Principal Investigator
affiliation: Washington University School of Medicine in St. Louis
facility: 
country: Malawi
citation: Garcia-Perez I, Posma JM, Gibson R, Chambers ES, Hansen TH, Vestergaard H, Hansen T, Beckmann M, Pedersen O, Elliott P, Stamler J, Nicholson JK, Draper J, Mathers JC, Holmes E, Frost G. Objective assessment of dietary patterns by use of metabolic phenotyping: a randomised, controlled, crossover trial. Lancet Diabetes Endocrinol. 2017 Mar;5(3):184-195. doi: 10.1016/S2213-8587(16)30419-3. Epub 2017 Jan 13.
PMID: 28089709
citation: S C Sri Harsha P, Abdul Wahab R, Cuparencu C, Dragsted LO, Brennan L. A Metabolomics Approach to the Identification of Urinary Biomarkers of Pea Intake. Nutrients. 2018 Dec 4;10(12):1911. doi: 10.3390/nu10121911.
PMID: 30518059
citation: Koppmair S, Kassie M, Qaim M. Farm production, market access and dietary diversity in Malawi. Public Health Nutr. 2017 Feb;20(2):325-335. doi: 10.1017/S1368980016002135. Epub 2016 Sep 9.
PMID: 27609557
citation: Eaton JC, Rothpletz-Puglia P, Dreker MR, Iannotti L, Lutter C, Kaganda J, Rayco-Solon P. Effectiveness of provision of animal-source foods for supporting optimal growth and development in children 6 to 59 months of age. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD012818. doi: 10.1002/14651858.CD012818.pub2.
PMID: 30779870
responsible party type: Sponsor
mesh term: Growth Disorders
provided document: 