<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/NCT02208531</url>
  </required_header>
  <id_info>
    <org_study_id>PR-13099</org_study_id>
    <nct_id>NCT02208531</nct_id>
  </id_info>
  <brief_title>Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children</brief_title>
  <acronym>TTS Bangladesh</acronym>
  <official_title>Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial&#xD;
      Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished&#xD;
      children's growth and development after a year of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 200 million children &lt;5 yrs do not reach their full potential due to poor nutrition and&#xD;
      inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct&#xD;
      developmental deficit in malnourished children and psychosocial stimulation (PS) is also&#xD;
      required.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Pilot two intervention methods and different delivery models of providing NC+PS to&#xD;
           refine the intervention and identify any difficulties.&#xD;
&#xD;
        2. Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children.&#xD;
&#xD;
        3. Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals&#xD;
           through a quasi-experimental design.&#xD;
&#xD;
      Methods: The study consists of 3 different sub-studies:&#xD;
&#xD;
        1. The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving&#xD;
           40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every&#xD;
           2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery&#xD;
           models and assess problems through focus group discussions with parents and staff of the&#xD;
           CCs.&#xD;
&#xD;
        2. For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those&#xD;
           malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40&#xD;
           children from each CC and evaluate a random subsample of 6 children from each of the CCs&#xD;
           using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators&#xD;
           (FCI) at baseline and endline.&#xD;
&#xD;
        3. The quasi experimental study will be conducted in 10 CCs randomized to&#xD;
           group-intervention or control with 40 mothers and children per CC. Mothers will come to&#xD;
           the CCs in groups of 6 with their children every fortnight. The children will be tested&#xD;
           at the beginning and after 12 months using the same tools in the main study.&#xD;
&#xD;
      Outcome variable: The main outcomes are children's language, mental and psychomotor&#xD;
      development measured on Bayley-III. In addition we expect improvements in FCI and mother's&#xD;
      child rearing knowledge and practices. We will also conduct cost analysis and based on the&#xD;
      success indicators, cost per successful outcome will be calculated from total cost of&#xD;
      intervention program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive, Language and Motor Composite Scores</measure>
    <time_frame>12 months</time_frame>
    <description>The outcomes are measured on Bayley-III test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometry multiple measures, viz. Weight, length/height and head circumference</measure>
    <time_frame>12 months</time_frame>
    <description>Children's weight, length/height and head circumference will be measured using standard methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behaviour</measure>
    <time_frame>12 months</time_frame>
    <description>The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Family Care Indicators</measure>
    <time_frame>12 months</time_frame>
    <description>This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6400</enrollment>
  <condition>Moderate and Severe Undernutrition</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychosocial Stimulation and Nutritional Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial Stimulation and Nutritional Care</intervention_name>
    <description>Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.</description>
    <arm_group_label>Psychosocial Stimulation and Nutritional Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderately and Severely malnourished children WAZ&lt;-2SD&#xD;
&#xD;
          -  Age: 6-24 months&#xD;
&#xD;
          -  Both male and female children&#xD;
&#xD;
          -  Living within 30 minutes walk from the Community Clinic&#xD;
&#xD;
          -  Parents giving consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Acute Malnutrition with complications requiring close monitoring and/or&#xD;
             hospitalization&#xD;
&#xD;
          -  Severe clinical pallor&#xD;
&#xD;
          -  Known chronic diseases like epilepsy, cerebral palsy, mental retardation&#xD;
&#xD;
          -  Twin/multiple birth&#xD;
&#xD;
        Children with above exclusion criteria or those whose parents do not wish to sign the&#xD;
        consent form will not be included in the evaluation sample but if they wish they will&#xD;
        receive the stimulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>International Centre for Diarrhoeal Disease Research, Bangladesh</name>
      <address>
        <city>Dhaka</city>
        <zip>1212</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>March 3, 2019</last_update_submitted>
  <last_update_submitted_qc>March 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early Childhood Development (ECD)</keyword>
  <keyword>Psychosocial stimulation</keyword>
  <keyword>Malnutrition</keyword>
  <keyword>Bangladesh</keyword>
  <keyword>Scaling up ECD</keyword>
  <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/NCT02208531
org study id: PR-13099
nct id: NCT02208531
lead sponsor: 
has dmc: No
We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial
      Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished
      children's growth and development after a year of intervention.
Over 200 million children <5 yrs do not reach their full potential due to poor nutrition and
      inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct
      developmental deficit in malnourished children and psychosocial stimulation (PS) is also
      required.

      Objectives:

        1. Pilot two intervention methods and different delivery models of providing NC+PS to
           refine the intervention and identify any difficulties.

        2. Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children.

        3. Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals
           through a quasi-experimental design.

      Methods: The study consists of 3 different sub-studies:

        1. The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving
           40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every
           2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery
           models and assess problems through focus group discussions with parents and staff of the
           CCs.

        2. For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those
           malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40
           children from each CC and evaluate a random subsample of 6 children from each of the CCs
           using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators
           (FCI) at baseline and endline.

        3. The quasi experimental study will be conducted in 10 CCs randomized to
           group-intervention or control with 40 mothers and children per CC. Mothers will come to
           the CCs in groups of 6 with their children every fortnight. The children will be tested
           at the beginning and after 12 months using the same tools in the main study.

      Outcome variable: The main outcomes are children's language, mental and psychomotor
      development measured on Bayley-III. In addition we expect improvements in FCI and mother's
      child rearing knowledge and practices. We will also conduct cost analysis and based on the
      success indicators, cost per successful outcome will be calculated from total cost of
      intervention program.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cognitive, Language and Motor Composite Scores
time frame: 12 months
description: The outcomes are measured on Bayley-III test.
measure: Anthropometry multiple measures, viz. Weight, length/height and head circumference
time frame: 12 months
description: Children's weight, length/height and head circumference will be measured using standard methods.
measure: Behaviour
time frame: 12 months
description: The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
measure: Family Care Indicators
time frame: 12 months
description: This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.
arm group label: Control
arm group type: No Intervention
arm group label: Psychosocial Stimulation and Nutritional Care
arm group type: Experimental
description: Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
intervention type: Behavioral
intervention name: Psychosocial Stimulation and Nutritional Care
description: Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
arm group label: Psychosocial Stimulation and Nutritional Care
criteria: 
gender: All
minimum age: 6 Months
maximum age: 24 Months
healthy volunteers: No
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Malnutrition