<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/NCT01679535</url>
  </required_header>
  <id_info>
    <org_study_id>TOMEDI-12-049</org_study_id>
    <nct_id>NCT01679535</nct_id>
  </id_info>
  <brief_title>A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya</brief_title>
  <official_title>A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nairobi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine if an education program about hygiene and child feeding practices,&#xD;
      taught by local village community health workers, will improve child growth and decrease the&#xD;
      prevalence of childhood malnutrition in a rural region of Kenya.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>malnutrition prevalence</measure>
    <time_frame>Measured when children are 24 months of age</time_frame>
    <description>Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child growth</measure>
    <time_frame>Measured when children are 24 months of age</time_frame>
    <description>Child growth as measured by change in z score of the children in each group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Prevalence of diarrhea</measure>
    <time_frame>Prevalence assessed when children reach 24 months of age</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Child Nutrition Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nutrition and hygiene education by community health workers</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>nutrition and hygiene education</intervention_name>
    <description>Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child of a mother living in the catchment area of the study who delivered during the&#xD;
             enrollment period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angelo J Tomedi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.</citation>
    <PMID>18207566</PMID>
  </results_reference>
  <results_reference>
    <citation>Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.</citation>
    <PMID>18206226</PMID>
  </results_reference>
  <results_reference>
    <citation>Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.</citation>
    <PMID>18289157</PMID>
  </results_reference>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>February 4, 2015</last_update_submitted>
  <last_update_submitted_qc>February 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Angelo Tomedi</investigator_full_name>
    <investigator_title>Visiting Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Infant nutrition disorder</keyword>
  <keyword>Child nutrition disorders</keyword>
  <keyword>Malnutrition</keyword>
  <keyword>Protein-energy malnutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01679535
org study id: TOMEDI-12-049
nct id: NCT01679535
lead sponsor: 
collaborator: 
has dmc: No
This study will determine if an education program about hygiene and child feeding practices,
      taught by local village community health workers, will improve child growth and decrease the
      prevalence of childhood malnutrition in a rural region of Kenya.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: malnutrition prevalence
time frame: Measured when children are 24 months of age
description: Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group
measure: Child growth
time frame: Measured when children are 24 months of age
description: Child growth as measured by change in z score of the children in each group
measure: Prevalence of diarrhea
time frame: Prevalence assessed when children reach 24 months of age
arm group label: Intervention
arm group type: Experimental
description: nutrition and hygiene education by community health workers
intervention type: Behavioral
intervention name: nutrition and hygiene education
description: Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers
arm group label: Intervention
criteria: 
gender: All
minimum age: 1 Month
maximum age: 6 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Angelo J Tomedi, MD
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
citation: Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
PMID: 18207566
citation: Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.
PMID: 18206226
citation: Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.
PMID: 18289157
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Angelo Tomedi
investigator title: Visiting Associate Professor
mesh term: Malnutrition
mesh term: Nutrition Disorders
mesh term: Child Nutrition Disorders