<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/NCT02245152</url>
  </required_header>
  <id_info>
    <org_study_id>IFPRI-2014-001</org_study_id>
    <secondary_id>DFATD</secondary_id>
    <nct_id>NCT02245152</nct_id>
  </id_info>
  <brief_title>The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study</brief_title>
  <acronym>PROMIS-BF</acronym>
  <official_title>The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Food Policy Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helen Keller International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Food Policy Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Globally, child undernutrition is the underlying cause for 3.1 million deaths of children&#xD;
      younger than 5 years. 18.7 million children under five years of age suffer from severe acute&#xD;
      malnutrition (SAM) and an additional 33 million children suffer from moderate acute&#xD;
      malnutrition, and are at risk of developing SAM&#xD;
&#xD;
      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute&#xD;
      malnutrition and programs that focus on the prevention of acute and chronic undernutrition -&#xD;
      resulting in many missed opportunities for using prevention platforms to screen and refer SAM&#xD;
      children, or for using screening and referral platforms to provide prevention services.&#xD;
&#xD;
      This project will address two critical gaps related to the integration of preventive and&#xD;
      treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically&#xD;
      integrated into routine health-center visits or mainstreamed into community outreach&#xD;
      programs; and 2) screening programs often do not offer any preventive services for those&#xD;
      children found not to be suffering from MAM/SAM at the time of screening; mothers of children&#xD;
      identified as non-MAM/SAM case are usually sent home without receiving any health or&#xD;
      nutrition inputs and as a result, may fail to come back for screening because they do not see&#xD;
      any tangible benefit associated with their participation in the screening. This project will&#xD;
      specifically address these gaps by assessing the effect of an integrated approach consisting&#xD;
      of higher screening coverage and preventive Behavior Change Communication (BCC) +&#xD;
      Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment&#xD;
      of child undernutrition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g.&#xD;
      to help prevent child undernutrition and enhance the coverage of screening, referral and&#xD;
      treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the&#xD;
      impact of the proposed intervention and to tease out the contribution of prevention and&#xD;
      enhanced coverage/treatment to the overall impact on child malnutrition.&#xD;
&#xD;
      The proposed study will therefore use two types of study designs. The first one is a repeated&#xD;
      cross-sectional design that will compare select study outcomes between intervention and&#xD;
      control groups at endline, after 24 months of program implementation. A repeated&#xD;
      cross-sectional study design among children 0-17 months, at baseline and at study endline (on&#xD;
      different children) will be used to assess the impact of the intervention on the prevalence&#xD;
      of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of&#xD;
      MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second proposed&#xD;
      study design entails a longitudinal design whereby individual children will be recruited at&#xD;
      birth and followed-up monthly until they reach 18 months of age. We anticipate needing&#xD;
      approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020&#xD;
      in the control group and 1,020 in the intervention group). This design will allow us to&#xD;
      assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2014</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 4</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>Prevalence of acute child malnutrition defined by WHZ&lt;-2 or MUAC &lt;125mm or bilateral pitting edema in children 0-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>Cross-sectional study&#xD;
To calculate WHZ scores the 2006 WHO growth reference will be used&#xD;
The MUAC criterion (125mm) is only used for children 6-17months of age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)</measure>
    <time_frame>monthly from study inclusion at 0 months to 17 months of age and at study endline</time_frame>
    <description>Cross-sectional study&#xD;
Longitudinal study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of child acute malnutrition defined by WHZ&lt;-2 or MUAC&lt;125mm</measure>
    <time_frame>monthly from study inclusion at 0 months to 17 months of age</time_frame>
    <description>Longitudinal study&#xD;
To calculate WHZ scores the 2006 WHO growth reference will be used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)</measure>
    <time_frame>monthly from study inclusion at 0 months to 17 months of age and at study endline</time_frame>
    <description>Cross-sectional study&#xD;
Longitudinal study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of child stunting defined by HAZ&lt;-2 in children 0-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>To calculate HAZ scores the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean WHZ-score in children 0 -17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>To calculate WHZ scores the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean HAZ-score in children 0-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>To calculate HAZ scores the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean mid-upper arm circumference in children 0-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean hemoglobin concentration in children 3-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>Hemocues will be used to measure Hb concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of child anemia (Hb concentration&lt;10g/dL) in children 3 - 17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of severe acute child malnutrition defined by a WHZ&lt;-3 or bilateral pitting edema or a MUAC&lt;115mm in children 0-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>The MUAC criterion (115mm) is only used for children 6-17months of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of severe stunting defined by a HAZ&lt;-3 in children 0-17 months of age</measure>
    <time_frame>After 24 months of program implementation</time_frame>
    <description>To calculate HAZ scores the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)</measure>
    <time_frame>After 24 months of program implementation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of child stunting defined by HAZ&lt;-2 in children from 0 to 17 months</measure>
    <time_frame>monthly from inclusion at 0 months to 17 months of age</time_frame>
    <description>To calculate HAZ score the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear growth velocity (HAZ increment/month)</measure>
    <time_frame>monthly from inclusion at 0 months to 17 months of age</time_frame>
    <description>To calculate HAZ score the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ponderal growth velocity (WHZ increment/month)</measure>
    <time_frame>monthly from inclusion at 0 months to 17 months of age</time_frame>
    <description>To calculate WHZ score the 2006 WHO growth reference will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight gain (weight increment/month)</measure>
    <time_frame>monthly from inclusion at 0 months to 17 months of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid-upper arm circumference gain (MUAC increment/month)</measure>
    <time_frame>monthly from inclusion at 0 months to 17 moths of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)</measure>
    <time_frame>monthly from inclusion at 0 months to 17 moths of age</time_frame>
    <description>Malaria will be tested in case of fever (or recalled fever over last 24hrs) use rapid tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse rate after treatment of MAM/SAM (proportion WHZ&lt;-2 or MUAC&lt;125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over total number of children treated)</measure>
    <time_frame>monthly from inclusion at 0 months to 17 months of age</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2400</enrollment>
  <condition>Child Acute Malnutrition</condition>
  <arm_group>
    <arm_group_label>PROMIS intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Small group behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly well-baby visits for children 0-17 months of age&#xD;
Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>LNS</intervention_name>
    <description>A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling</description>
    <arm_group_label>PROMIS intervention</arm_group_label>
    <other_name>Lipid-based nutrient supplement (LNS)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child's health and nutrition topics</intervention_name>
    <description>After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time).&#xD;
Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children.</description>
    <arm_group_label>PROMIS intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>National policy well-baby visits</intervention_name>
    <arm_group_label>PROMIS intervention</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Cross-sectional study (baseline and endline) (n=2,310)&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one index child 0-17 months of age in the household&#xD;
&#xD;
          -  Mother should be living in the study area since the index child's delivery&#xD;
&#xD;
          -  Singleton infants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Index child should not present congenital deformations that hamper anthropometric&#xD;
        measurements&#xD;
&#xD;
        Longitudinal study (n=2,180)&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  child 0-1.4 months of age;&#xD;
&#xD;
          -  Mother should be living in the study area since the index child's delivery&#xD;
&#xD;
          -  Singleton infants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital malformations that make anthropometric measurements impossible&#xD;
&#xD;
          -  Mother planning to leave the study area in the coming year&#xD;
&#xD;
          -  Children of 1.5 month of age or older at study inclusion&#xD;
&#xD;
          -  WHZ&lt;-2 both at enrollment and at the first follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Ruel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Celestin Somda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helen Keller International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gourcy Health District</name>
      <address>
        <city>Gourcy</city>
        <state>Région Du Nord</state>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>child acute malnutrition</keyword>
  <keyword>prevention</keyword>
  <keyword>behavior change communication</keyword>
  <keyword>lipid-based nutrient supplement</keyword>
  <keyword>screening coverage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT02245152
org study id: IFPRI-2014-001
secondary id: DFATD
nct id: NCT02245152
lead sponsor: 
collaborator: 
has dmc: No
Globally, child undernutrition is the underlying cause for 3.1 million deaths of children
      younger than 5 years. 18.7 million children under five years of age suffer from severe acute
      malnutrition (SAM) and an additional 33 million children suffer from moderate acute
      malnutrition, and are at risk of developing SAM

      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute
      malnutrition and programs that focus on the prevention of acute and chronic undernutrition -
      resulting in many missed opportunities for using prevention platforms to screen and refer SAM
      children, or for using screening and referral platforms to provide prevention services.

      This project will address two critical gaps related to the integration of preventive and
      treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically
      integrated into routine health-center visits or mainstreamed into community outreach
      programs; and 2) screening programs often do not offer any preventive services for those
      children found not to be suffering from MAM/SAM at the time of screening; mothers of children
      identified as non-MAM/SAM case are usually sent home without receiving any health or
      nutrition inputs and as a result, may fail to come back for screening because they do not see
      any tangible benefit associated with their participation in the screening. This project will
      specifically address these gaps by assessing the effect of an integrated approach consisting
      of higher screening coverage and preventive Behavior Change Communication (BCC) +
      Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment
      of child undernutrition.
Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g.
      to help prevent child undernutrition and enhance the coverage of screening, referral and
      treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the
      impact of the proposed intervention and to tease out the contribution of prevention and
      enhanced coverage/treatment to the overall impact on child malnutrition.

      The proposed study will therefore use two types of study designs. The first one is a repeated
      cross-sectional design that will compare select study outcomes between intervention and
      control groups at endline, after 24 months of program implementation. A repeated
      cross-sectional study design among children 0-17 months, at baseline and at study endline (on
      different children) will be used to assess the impact of the intervention on the prevalence
      of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of
      MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second proposed
      study design entails a longitudinal design whereby individual children will be recruited at
      birth and followed-up monthly until they reach 18 months of age. We anticipate needing
      approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020
      in the control group and 1,020 in the intervention group). This design will allow us to
      assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age
time frame: After 24 months of program implementation
description: Cross-sectional study
To calculate WHZ scores the 2006 WHO growth reference will be used
The MUAC criterion (125mm) is only used for children 6-17months of age
measure: Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
time frame: monthly from study inclusion at 0 months to 17 months of age and at study endline
description: Cross-sectional study
Longitudinal study
measure: Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
time frame: monthly from study inclusion at 0 months to 17 months of age
description: Longitudinal study
To calculate WHZ scores the 2006 WHO growth reference will be used
measure: Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
time frame: monthly from study inclusion at 0 months to 17 months of age and at study endline
description: Cross-sectional study
Longitudinal study
measure: Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age
time frame: After 24 months of program implementation
description: To calculate HAZ scores the 2006 WHO growth reference will be used
measure: Mean WHZ-score in children 0 -17 months of age
time frame: After 24 months of program implementation
description: To calculate WHZ scores the 2006 WHO growth reference will be used
measure: Mean HAZ-score in children 0-17 months of age
time frame: After 24 months of program implementation
description: To calculate HAZ scores the 2006 WHO growth reference will be used
measure: Mean mid-upper arm circumference in children 0-17 months of age
time frame: After 24 months of program implementation
measure: Mean hemoglobin concentration in children 3-17 months of age
time frame: After 24 months of program implementation
description: Hemocues will be used to measure Hb concentration
measure: Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age
time frame: After 24 months of program implementation
measure: Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age
time frame: After 24 months of program implementation
description: The MUAC criterion (115mm) is only used for children 6-17months of age
measure: Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 months of age
time frame: After 24 months of program implementation
description: To calculate HAZ scores the 2006 WHO growth reference will be used
measure: Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)
time frame: After 24 months of program implementation
measure: Incidence of child stunting defined by HAZ<-2 in children from 0 to 17 months
time frame: monthly from inclusion at 0 months to 17 months of age
description: To calculate HAZ score the 2006 WHO growth reference will be used
measure: Linear growth velocity (HAZ increment/month)
time frame: monthly from inclusion at 0 months to 17 months of age
description: To calculate HAZ score the 2006 WHO growth reference will be used
measure: Ponderal growth velocity (WHZ increment/month)
time frame: monthly from inclusion at 0 months to 17 months of age
description: To calculate WHZ score the 2006 WHO growth reference will be used
measure: Weight gain (weight increment/month)
time frame: monthly from inclusion at 0 months to 17 months of age
measure: Mid-upper arm circumference gain (MUAC increment/month)
time frame: monthly from inclusion at 0 months to 17 moths of age
measure: Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
time frame: monthly from inclusion at 0 months to 17 moths of age
description: Malaria will be tested in case of fever (or recalled fever over last 24hrs) use rapid tests
measure: Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over total number of children treated)
time frame: monthly from inclusion at 0 months to 17 months of age
arm group label: PROMIS intervention
arm group type: Experimental
description: Small group behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly well-baby visits for children 0-17 months of age
Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day)
arm group label: control
arm group type: Active Comparator
description: Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers.
intervention type: Dietary Supplement
intervention name: LNS
description: A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling
arm group label: PROMIS intervention
other name: Lipid-based nutrient supplement (LNS)
intervention type: Behavioral
intervention name: Child's health and nutrition topics
description: After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time).
Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children.
arm group label: PROMIS intervention
intervention type: Behavioral
intervention name: National policy well-baby visits
arm group label: PROMIS intervention
arm group label: control
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Marie Ruel, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Jean-Celestin Somda, MD
role: Principal Investigator
affiliation: Helen Keller International
facility: 
country: Burkina Faso
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Child Nutrition Disorders