<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/NCT02242539</url>
  </required_header>
  <id_info>
    <org_study_id>14-2948</org_study_id>
    <nct_id>NCT02242539</nct_id>
  </id_info>
  <brief_title>Tools to Improve Parental Recognition of Developmental Deficits in Children</brief_title>
  <official_title>Tools to Improve Parental Recognition of Developmental Deficits in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Innovations for Poverty Action</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, we aim to improve child nutrition by increasing parents' awareness of their&#xD;
      children's physical growth. We use a cluster-randomized trial design to evaluate two&#xD;
      interventions that provide parents with regular information on their children's physical&#xD;
      development and growth: 1) distribution of full-sized growth charts for measurement of child&#xD;
      height within households; and 2) organization of community-based meetings, during which&#xD;
      children's height and weight are measured by trained project staff.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The target population for the study will be children between the ages of 6 and 18 months at&#xD;
      baseline living in small-scale farming households in Chipata District, Zambia. As part of a&#xD;
      cluster-randomized trial titled &quot;Food Constraints, Yield Uncertainty and 'Ganyu' Labor&quot;&#xD;
      funded by IZA-DFID (PI: G Fink), 3,100 farming households in approximately 180 rural villages&#xD;
      in Eastern Province are currently enrolled in a two-year study, which aims at assessing the&#xD;
      effect of food loan programs on agricultural productivity. The study described here uses the&#xD;
      &quot;Food Constraints&quot; population as a sampling frame; all households enrolled in the &quot;Food&#xD;
      Constraints&quot; program that have a child between 6 and 18 months are invited to participate in&#xD;
      this add-on trial. We anticipate that there will be around 600 eligible households recruited&#xD;
      for this study. Study duration is about 18 months. Selected households will be visited for&#xD;
      study enrollment and a short baseline assessment in September 2014, at which time the two&#xD;
      interventions will also be rolled out. Final impact of the interventions will be assessed one&#xD;
      year later, in September 2015.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Height-for-age z-score</measure>
    <time_frame>At the end of one year</time_frame>
    <description>Children's heights will be measured and height-fore-age z-scores will be determined using standards published by the World Health Organization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child development outcomes</measure>
    <time_frame>At the end of one year</time_frame>
    <description>Through parental reports and child tasks we will measure various aspects of child development, including motor skills and verbal skills</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mid-upper arm circumference (MUAC)</measure>
    <time_frame>At the end of one year</time_frame>
    <description>Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>At the end of one year</time_frame>
    <description>Parents will be asked to report on children's dietary intake during the day preceding the survey</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">547</enrollment>
  <condition>Malnutrition</condition>
  <condition>Child Development</condition>
  <arm_group>
    <arm_group_label>Height measurement poster</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Community-based monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Height measurement poster</intervention_name>
    <description>Each household is provided with a poster which study personnel help to hang on the wall. The poster clearly indicates height-for-age benchmarks and stunting cut-offs for study-age children. Parents are provided training on how to measure their children at regular intervals, and interpret height readings to determine whether their child is developing normally or is stunted.</description>
    <arm_group_label>Height measurement poster</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community-based monitoring</intervention_name>
    <description>Once every three months, villages are visited by study staff who measure children's heights and weights, and parents are informed if their children are below the reference measures established by the World Health Organization. If a child's weight is such that the child is classified as severely malnourished, the child is referred to the nearest health center for treatment. If the child is stunted (height-for-age z-score more than 2 standard deviations below the reference median), we provide parents with a supply of &quot;Yummy Soy&quot; powder, a fortified soy and maize mix popular among parents and widely available in local super markets. Parents are instructed to give one or two tea spoons of the mix to the child each day.</description>
    <arm_group_label>Community-based monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All households with a child between the ages of 6 and 18 months at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Günther Fink, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Rockers, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Household sample</name>
      <address>
        <city>Chipata District</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>January 11, 2016</last_update_submitted>
  <last_update_submitted_qc>January 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Peter Rockers</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT02242539
org study id: 14-2948
nct id: NCT02242539
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In this study, we aim to improve child nutrition by increasing parents' awareness of their
      children's physical growth. We use a cluster-randomized trial design to evaluate two
      interventions that provide parents with regular information on their children's physical
      development and growth: 1) distribution of full-sized growth charts for measurement of child
      height within households; and 2) organization of community-based meetings, during which
      children's height and weight are measured by trained project staff.
The target population for the study will be children between the ages of 6 and 18 months at
      baseline living in small-scale farming households in Chipata District, Zambia. As part of a
      cluster-randomized trial titled "Food Constraints, Yield Uncertainty and 'Ganyu' Labor"
      funded by IZA-DFID (PI: G Fink), 3,100 farming households in approximately 180 rural villages
      in Eastern Province are currently enrolled in a two-year study, which aims at assessing the
      effect of food loan programs on agricultural productivity. The study described here uses the
      "Food Constraints" population as a sampling frame; all households enrolled in the "Food
      Constraints" program that have a child between 6 and 18 months are invited to participate in
      this add-on trial. We anticipate that there will be around 600 eligible households recruited
      for this study. Study duration is about 18 months. Selected households will be visited for
      study enrollment and a short baseline assessment in September 2014, at which time the two
      interventions will also be rolled out. Final impact of the interventions will be assessed one
      year later, in September 2015.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Height-for-age z-score
time frame: At the end of one year
description: Children's heights will be measured and height-fore-age z-scores will be determined using standards published by the World Health Organization
measure: Child development outcomes
time frame: At the end of one year
description: Through parental reports and child tasks we will measure various aspects of child development, including motor skills and verbal skills
measure: Mid-upper arm circumference (MUAC)
time frame: At the end of one year
description: Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips
measure: Dietary intake
time frame: At the end of one year
description: Parents will be asked to report on children's dietary intake during the day preceding the survey
arm group label: Height measurement poster
arm group type: Experimental
arm group label: Community-based monitoring
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Height measurement poster
description: Each household is provided with a poster which study personnel help to hang on the wall. The poster clearly indicates height-for-age benchmarks and stunting cut-offs for study-age children. Parents are provided training on how to measure their children at regular intervals, and interpret height readings to determine whether their child is developing normally or is stunted.
arm group label: Height measurement poster
intervention type: Behavioral
intervention name: Community-based monitoring
description: Once every three months, villages are visited by study staff who measure children's heights and weights, and parents are informed if their children are below the reference measures established by the World Health Organization. If a child's weight is such that the child is classified as severely malnourished, the child is referred to the nearest health center for treatment. If the child is stunted (height-for-age z-score more than 2 standard deviations below the reference median), we provide parents with a supply of "Yummy Soy" powder, a fortified soy and maize mix popular among parents and widely available in local super markets. Parents are instructed to give one or two tea spoons of the mix to the child each day.
arm group label: Community-based monitoring
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Günther Fink, PhD
role: Principal Investigator
affiliation: Harvard University
last name: Peter Rockers, ScD
role: Principal Investigator
affiliation: Boston University
facility: 
country: Zambia
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Peter Rockers
investigator title: Assistant Professor
mesh term: Malnutrition