<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/NCT01678716</url>
  </required_header>
  <id_info>
    <org_study_id>AED ARTS/IFPRI-S-01</org_study_id>
    <secondary_id>IFPRI-107033</secondary_id>
    <nct_id>NCT01678716</nct_id>
  </id_info>
  <brief_title>Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh</brief_title>
  <official_title>1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Food Policy Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Food Policy Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This complex evaluation of a large-scale program uses a cluster-randomized design where 20&#xD;
      geographic clusters (subdistricts) were randomized to study two sets of interventions. For&#xD;
      the evaluation of behavior change interventions only, the 20 clusters were randomized to 10&#xD;
      intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a&#xD;
      market-based model for delivering micronutrient powders (MNP) along with behavior change&#xD;
      interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior&#xD;
      Change Communication (BCC)-only area and MNP+BCC areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design uses a repeated cross-sectional design, with multiple age-group samples for&#xD;
      multiple outcomes [since each set of outcomes can only be assessed in the relevant age group&#xD;
      for the outcome; e.g., exclusive breastfeeding is only assessed in children 0-6 months of&#xD;
      age]. These include:&#xD;
&#xD;
        1. For the evaluation of behavior change intervention only:&#xD;
&#xD;
             -  0-6 months for breastfeeding outcomes&#xD;
&#xD;
             -  6-23.9 months for complementary feeding outcomes (in the behavior change&#xD;
                intervention evaluation)&#xD;
&#xD;
             -  24-48 months for child anthropometric outcomes (related to the behavior change&#xD;
                interventions).&#xD;
&#xD;
        2. for the substudy on behavior change and micronutrient powder interventions combined -&#xD;
           6-23.9 months for anemia and anthropometric outcomes&#xD;
&#xD;
      A community-based random sample of children 0-6 months, 6-23.9 months, 24-48 months old was&#xD;
      surveyed at baseline (April-June 2010). The original anemia sub-study design had proposed&#xD;
      surveying children 6.23.9 months of age for the MNP intervention in April-June 2013 and for&#xD;
      the behavior change intervention in April-June 2014. Based on program implementation&#xD;
      timelines, the endline survey dates were extended by one year such that the above age groups&#xD;
      were then sampled and surveyed in community-based surveys in April-June 2014.&#xD;
&#xD;
      Infant feeding practices will be assessed using before-after intervention-comparison area&#xD;
      group differences between 2010, and 2013 and 2014. Specifically, breast feeding will be&#xD;
      assessed in children 0-6 months of age (sampled separately) and complementary feeding will be&#xD;
      assessed in children 6-23.9 months of age (sampled separately).&#xD;
&#xD;
      Stunting will be assessed in the sample of children 24-48 months of age using before-after&#xD;
      intervention-comparison group differences between 2010 and 2014.&#xD;
&#xD;
      In addition, the investigators will evaluate the processes through which the programs roll&#xD;
      out using a mix of qualitative and quantitative research methods. Qualitative research&#xD;
      methods will help to understand drivers of promotion and sales of MNPs by frontline health&#xD;
      workers, as well as household level determinants and dynamics related to enabling purchase&#xD;
      and use of the MNP and adhering to behavioral recommendations. Quantitative surveys of&#xD;
      frontline health workers will help document their awareness about IYCF, MNPs, training, and&#xD;
      sales, while quantitative surveys of the households will help document household level&#xD;
      awareness, purchase and use of MNPs and awareness and adherence to IYCF practices for&#xD;
      children in the target age range.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exclusive breastfeeding (EBF) among children 0-6 months of age</measure>
    <time_frame>4 years after baseline</time_frame>
    <description>EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child anthropometry (height, weight) among children 24-48 months of age</measure>
    <time_frame>4 years after baseline</time_frame>
    <description>Child height and weight will be measured among the repeated cross-sectional of children living in the study villages. These will be converted into z-scores based on the WHO growth reference standards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complementary feeding among children 6-23.9 months of age</measure>
    <time_frame>4 years after baseline</time_frame>
    <description>Complementary feeding indicators that include timely introduction of complementary feeding (infants 6-8 months), dietary diversity, minimum dietary diversity, minimum dietary diversity, are among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures in this age group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anemia among children 6-23.9 months</measure>
    <time_frame>4 years after baseline</time_frame>
    <description>Anemia will be measured using Hemocue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Iron deficiency</measure>
    <time_frame>3 years</time_frame>
    <description>Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">8800</enrollment>
  <condition>Child Malnutrition</condition>
  <condition>Breastfeeding</condition>
  <condition>Complementary Feeding</condition>
  <condition>Childhood Anemia</condition>
  <arm_group>
    <arm_group_label>Essential Health Care (EHC) only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm is the basic comparison arm, which will receive the standard package of health services offered through BRAC's essential health care (basic antenatal care, basic counseling on health and nutrition through health worker home visits. In addition, a nationwide mass media campaign on IYCF practices will ensure exposure to some messages about IYCF behaviors in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EHC + Micronutrient Powders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will be based on the EHC platform but will also include EHC platform health workers promoting and selling the micronutrient powders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EHC + BCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will have a behavior chance communications intervention to improve infant and young child feeding practices. The intervention will be delivered primarily by the frontline health workers who will visit mothers in their homes and counsel them on essential IYCF practices.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EHC + BCC + Micronutrient powders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will contain both the behavior change communication and the micronutrient powder sales intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EHC + BCC</intervention_name>
    <description>This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices</description>
    <arm_group_label>EHC + BCC</arm_group_label>
    <arm_group_label>EHC + BCC + Micronutrient powders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Micronutrient powders</intervention_name>
    <description>In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name &quot;Pushtikona&quot; in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others.</description>
    <arm_group_label>EHC + BCC + Micronutrient powders</arm_group_label>
    <arm_group_label>EHC + Micronutrient Powders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mass media</intervention_name>
    <description>A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.</description>
    <arm_group_label>EHC + BCC</arm_group_label>
    <arm_group_label>EHC + BCC + Micronutrient powders</arm_group_label>
    <arm_group_label>EHC + Micronutrient Powders</arm_group_label>
    <arm_group_label>Essential Health Care (EHC) only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child age &lt; 60 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Purnima Menon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rahul Rawat, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Food Policy Research Institute</name>
      <address>
        <city>Dhaka</city>
        <zip>1212</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>February 29, 2016</last_update_submitted>
  <last_update_submitted_qc>February 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anemia</keyword>
  <keyword>Breastfeeding</keyword>
  <keyword>Complementary feeding</keyword>
  <keyword>Stunting</keyword>
  <keyword>Wasting</keyword>
  <keyword>Underweight</keyword>
  <keyword>Micronutrient powder</keyword>
  <keyword>Behavior change counseling</keyword>
  <keyword>Frontline health worker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
    <mesh_term>Growth Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
    <mesh_term>Trace Elements</mesh_term>
  </intervention_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/NCT01678716
org study id: AED ARTS/IFPRI-S-01
secondary id: IFPRI-107033
nct id: NCT01678716
lead sponsor: 
has dmc: No
This complex evaluation of a large-scale program uses a cluster-randomized design where 20
      geographic clusters (subdistricts) were randomized to study two sets of interventions. For
      the evaluation of behavior change interventions only, the 20 clusters were randomized to 10
      intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a
      market-based model for delivering micronutrient powders (MNP) along with behavior change
      interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior
      Change Communication (BCC)-only area and MNP+BCC areas.
The design uses a repeated cross-sectional design, with multiple age-group samples for
      multiple outcomes [since each set of outcomes can only be assessed in the relevant age group
      for the outcome; e.g., exclusive breastfeeding is only assessed in children 0-6 months of
      age]. These include:

        1. For the evaluation of behavior change intervention only:

             -  0-6 months for breastfeeding outcomes

             -  6-23.9 months for complementary feeding outcomes (in the behavior change
                intervention evaluation)

             -  24-48 months for child anthropometric outcomes (related to the behavior change
                interventions).

        2. for the substudy on behavior change and micronutrient powder interventions combined -
           6-23.9 months for anemia and anthropometric outcomes

      A community-based random sample of children 0-6 months, 6-23.9 months, 24-48 months old was
      surveyed at baseline (April-June 2010). The original anemia sub-study design had proposed
      surveying children 6.23.9 months of age for the MNP intervention in April-June 2013 and for
      the behavior change intervention in April-June 2014. Based on program implementation
      timelines, the endline survey dates were extended by one year such that the above age groups
      were then sampled and surveyed in community-based surveys in April-June 2014.

      Infant feeding practices will be assessed using before-after intervention-comparison area
      group differences between 2010, and 2013 and 2014. Specifically, breast feeding will be
      assessed in children 0-6 months of age (sampled separately) and complementary feeding will be
      assessed in children 6-23.9 months of age (sampled separately).

      Stunting will be assessed in the sample of children 24-48 months of age using before-after
      intervention-comparison group differences between 2010 and 2014.

      In addition, the investigators will evaluate the processes through which the programs roll
      out using a mix of qualitative and quantitative research methods. Qualitative research
      methods will help to understand drivers of promotion and sales of MNPs by frontline health
      workers, as well as household level determinants and dynamics related to enabling purchase
      and use of the MNP and adhering to behavioral recommendations. Quantitative surveys of
      frontline health workers will help document their awareness about IYCF, MNPs, training, and
      sales, while quantitative surveys of the households will help document household level
      awareness, purchase and use of MNPs and awareness and adherence to IYCF practices for
      children in the target age range.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Exclusive breastfeeding (EBF) among children 0-6 months of age
time frame: 4 years after baseline
description: EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures
measure: Child anthropometry (height, weight) among children 24-48 months of age
time frame: 4 years after baseline
description: Child height and weight will be measured among the repeated cross-sectional of children living in the study villages. These will be converted into z-scores based on the WHO growth reference standards.
measure: Complementary feeding among children 6-23.9 months of age
time frame: 4 years after baseline
description: Complementary feeding indicators that include timely introduction of complementary feeding (infants 6-8 months), dietary diversity, minimum dietary diversity, minimum dietary diversity, are among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures in this age group.
measure: Anemia among children 6-23.9 months
time frame: 4 years after baseline
description: Anemia will be measured using Hemocue
measure: Iron deficiency
time frame: 3 years
description: Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.
arm group label: Essential Health Care (EHC) only
arm group type: Active Comparator
description: This arm is the basic comparison arm, which will receive the standard package of health services offered through BRAC's essential health care (basic antenatal care, basic counseling on health and nutrition through health worker home visits. In addition, a nationwide mass media campaign on IYCF practices will ensure exposure to some messages about IYCF behaviors in this arm.
arm group label: EHC + Micronutrient Powders
arm group type: Experimental
description: This arm will be based on the EHC platform but will also include EHC platform health workers promoting and selling the micronutrient powders.
arm group label: EHC + BCC
arm group type: Experimental
description: This arm will have a behavior chance communications intervention to improve infant and young child feeding practices. The intervention will be delivered primarily by the frontline health workers who will visit mothers in their homes and counsel them on essential IYCF practices.
arm group label: EHC + BCC + Micronutrient powders
arm group type: Experimental
description: This arm will contain both the behavior change communication and the micronutrient powder sales intervention.
intervention type: Behavioral
intervention name: EHC + BCC
description: This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices
arm group label: EHC + BCC
arm group label: EHC + BCC + Micronutrient powders
intervention type: Dietary Supplement
intervention name: Micronutrient powders
description: In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name "Pushtikona" in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others.
arm group label: EHC + BCC + Micronutrient powders
arm group label: EHC + Micronutrient Powders
intervention type: Behavioral
intervention name: Mass media
description: A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.
arm group label: EHC + BCC
arm group label: EHC + BCC + Micronutrient powders
arm group label: EHC + Micronutrient Powders
arm group label: Essential Health Care (EHC) only
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Purnima Menon, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Rahul Rawat, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Anemia
mesh term: Malnutrition
mesh term: Child Nutrition Disorders
mesh term: Growth Disorders
mesh term: Micronutrients
mesh term: Trace Elements