<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/NCT01660958</url>
  </required_header>
  <id_info>
    <org_study_id>00048720</org_study_id>
    <nct_id>NCT01660958</nct_id>
  </id_info>
  <brief_title>Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India</brief_title>
  <acronym>GrowSmart</acronym>
  <official_title>Innovative Strategies to Promote Early Child Development Among Low-income Rural Infants and Preschoolers in India Through Multiple Micronutrient Fortification and Early Learning Opportunities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Council of Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Mathile Institute for the Advancement of Human Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Micronutrient Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Project Grow Smart evaluates the impact fortification with multiple micronutrient powders&#xD;
      (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient&#xD;
      status, growth, and morbidity (secondary outcomes) among young children in rural India&#xD;
      (Nalgonda district of Telegana). There is an infant phase and a preschool phase;&#xD;
      investigators, study team members, and participants are unaware of whether the fortification&#xD;
      is MNP vs. placebo.&#xD;
&#xD;
      The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP&#xD;
      vs. placebo and early learning vs. routine care), conducted through home visits. Sachets&#xD;
      (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are:&#xD;
      1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads&#xD;
      to better development; 3) Integrated MNP plus early learning leads to better development&#xD;
      through both additive and synergistic processes. Developmental evaluations and anthropometric&#xD;
      measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood&#xD;
      draws for micronutrient status are performed at baseline and endline. Morbidity measures are&#xD;
      collected monthly using a morbidity form, modeled after the Demographic and Health Survey.&#xD;
&#xD;
      The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC)&#xD;
      (preschools). AWC are classified as high or low stimulation, based on an objective&#xD;
      observational rating system of the physical environment of the preschools and teacher-child&#xD;
      interactions. Preschools are categorized into high/low-quality based on median split,&#xD;
      followed by random assignment of MNP/placebo nested within high/low-quality preschools. The&#xD;
      hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and&#xD;
      micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the&#xD;
      quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The&#xD;
      intervention has been modified to coincide with the academic term (September-May).&#xD;
      Evaluations are conducted at baseline (September) and end-line (prior to May), with an&#xD;
      8-month intervention period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project Grow Smart has two phases: an infant phase and a preschool phase. The design of the&#xD;
      two phases differs, although both evaluate the impact of fortification with multiple&#xD;
      micronutrient powders (MNP) vs. placebo on child development.&#xD;
&#xD;
      In the infant phase, 6-14 month old infants are recruited and randomized into one of four&#xD;
      cells to receive: placebo, placebo plus early learning, MNP alone, and MNP plus early&#xD;
      learning (integrated intervention). Interventions are delivered through biweekly&#xD;
      (twice/month) home visits by Village Level Workers. Families of all infants receive&#xD;
      information on iron rich foods.&#xD;
&#xD;
      The preschool phase is conducted in 22 Anganwadi Centers (AWC) (i.e., preschools). AWC&#xD;
      quality is assessed, based on a 109-item observation scale, organized into 18 categories,&#xD;
      based on two validated scales: Early Childhood Environment Rating Scale-Revised (ECERS-R) and&#xD;
      HOME Inventory, modified to rate the quality of learning opportunities and teacher-child&#xD;
      interactions. After training and establishing inter-rater reliability, two psychologists&#xD;
      spend four hours in each preschool and independently complete the observation. Scores are&#xD;
      summed and averaged. Based on a median split, preschools are categorized into&#xD;
      high/low-quality with random assignment of MNP/placebo nested within high/low-quality&#xD;
      preschools. Classifications are unknown by investigators, study team, or preschools.&#xD;
&#xD;
      The preschool protocol has been modified to ensure that the trial coincides with the academic&#xD;
      term (September-May) to avoid losing the oldest children who transfer to private or primary&#xD;
      schools. Baseline evaluations are conducted in September and end-line evaluations are&#xD;
      conducted prior to May. Mid-line evaluations have been eliminated. The intervention is&#xD;
      delivered over 8 months. The MNP/placebo was supplied to preschools in identical packets of&#xD;
      200 grams, including two measuring spoons of 1 and 0.5 grams. Each packet includes a&#xD;
      manufacturer-assigned alphabetic code. AWC workers mix the MNP/placebo into the first bites&#xD;
      of the preschoolers' mid-day meal. Mothers receive information on iron-rich food.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</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>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>The infant phase is a factorial design.&#xD;
The preschool phase is a cluster-randomized trial (MNP/placebo nested within high/low-quality preschools).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infants: Change in cognitive, language, motor, and socio-emotional development</measure>
    <time_frame>Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)</time_frame>
    <description>Data on infants' cognitive, language, motor, and socio-emotional development will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation using the Mullens Scales of Early Learning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preschoolers: Change in cognitive, language, motor, and socio-emotional development</measure>
    <time_frame>Baseline and End-Point (8mo post BL)</time_frame>
    <description>Data on preschoolers' cognitive, language, motor, and socio-emotional development will be collected at baseline and the 8-month follow-up evaluation using the Mullens Scales of Early Learning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infants: Change in micronutrient Status</measure>
    <time_frame>Baseline and End-Point (12 mo post-baseline)</time_frame>
    <description>Data on infants' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 12-month follow-up evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preschoolers: Change in micronutrient Status</measure>
    <time_frame>Baseline and End-Point (8mo post BL)</time_frame>
    <description>Data on preschoolers' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 8-month follow-up evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infants: Change in weight and height</measure>
    <time_frame>Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)</time_frame>
    <description>Data on infants' weight and height will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preschoolers: Change in weight and height</measure>
    <time_frame>Baseline and End-Point (8mo post BL)</time_frame>
    <description>Data on preschoolers' weight and height will be collected at baseline and the 8-month follow-up evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infants: Morbidity</measure>
    <time_frame>Baseline and once a month (for 12mo post BL)</time_frame>
    <description>Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preschoolers: Morbidity</measure>
    <time_frame>Baseline and once a month (for 8mo post BL)</time_frame>
    <description>Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">834</enrollment>
  <condition>Nutritional Deficiencies</condition>
  <condition>Developmental Delay</condition>
  <arm_group>
    <arm_group_label>Infants: MNP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• Infants will receive sachets of multiple micronutrient powder (MNP) vs. placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants: Early Learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• Infant will receive early learning messages delivered in the home by village level workers vs. routine care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants: No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).&#xD;
Infant phase. Routine care - no early learning intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants: MNP/Early Learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants receive the MNP plus early learning intervention by receiving MNP sachets&#xD;
Caregivers receive early learning messaged delivered at home biweekly for one year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preschoolers:MNP/High qual preschool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.&#xD;
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.&#xD;
Preschools that are classified as high quality preschools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preschoolers:Placebo/High qual preschool</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).&#xD;
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.&#xD;
Preschools that are classified as high quality preschools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preschoolers:MNP/Low qual preschool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.&#xD;
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.&#xD;
Preschools that are classified as low quality preschools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preschoolers:Placebo/Low qual preschool</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).&#xD;
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.&#xD;
Preschools that are classified as low quality preschools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MNP</intervention_name>
    <description>The formulation of the multiple micronutrient powder (MNP) was based on low micronutrient intake, low bioavailability of iron and zinc in the Indian diet, and current World Health Organization (WHO)and Indian recommendations regarding fortification and age-specific nutrient requirements. The MNP formulations were produced by a certified company in India and include: Iron, Vitamin A, Vitamin C, Folic Acid, Zinc, Vitamin B12 Vitamin B2, plus filler (maltodextrin). Placebo included riboflavin and maltodextrin.</description>
    <arm_group_label>Infants: MNP</arm_group_label>
    <arm_group_label>Infants: MNP/Early Learning</arm_group_label>
    <arm_group_label>Preschoolers:MNP/High qual preschool</arm_group_label>
    <arm_group_label>Preschoolers:MNP/Low qual preschool</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early Learning</intervention_name>
    <description>• Infant will benefit from interventions that are based on responsive parenting, whereby caregivers respond to children's cues, provide opportunities for exploration, and engage in nurturant and reciprocal communication.</description>
    <arm_group_label>Infants: Early Learning</arm_group_label>
    <arm_group_label>Infants: MNP/Early Learning</arm_group_label>
    <other_name>Care for Development</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participating children must be in one of two age groups: infants: 6-14 months or&#xD;
             preschoolers: 30-48 months, inclusive, at time of recruitment.&#xD;
&#xD;
          -  Participants must reside in the Nalgonda district of Telengana, India.&#xD;
&#xD;
          -  Preschoolers must attend an Anganwadi Center (preschool) in the Nalgonda district that&#xD;
             is participating in Project Grow Smart.&#xD;
&#xD;
          -  Participating caregivers must be at least 18 years of age at the time of recruitment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with chronic diseases, developmental disabilities, mental retardation, or&#xD;
             severe physical handicaps will be excluded&#xD;
&#xD;
          -  Children with severe stunting ( &lt;= -3 standard deviation of length-for-age z-score) or&#xD;
             severe anemia (hemoglobin &lt; 7 g/dl) will be excluded and referred to a local hospital&#xD;
             for evaluation and intervention, as needed..&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>48 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen M Black, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Madhavan K. Nair, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NATIONAL INSTITUTE OF NUTRITION</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Nutrition</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 14, 2019</last_update_submitted>
  <last_update_submitted_qc>August 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Maureen Black</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Micronutrient Deficiencies</keyword>
  <keyword>Early Child Development</keyword>
  <keyword>Infant Growth</keyword>
  <keyword>Iron Deficiency</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/NCT01660958
org study id: 00048720
nct id: NCT01660958
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Project Grow Smart evaluates the impact fortification with multiple micronutrient powders
      (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient
      status, growth, and morbidity (secondary outcomes) among young children in rural India
      (Nalgonda district of Telegana). There is an infant phase and a preschool phase;
      investigators, study team members, and participants are unaware of whether the fortification
      is MNP vs. placebo.

      The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP
      vs. placebo and early learning vs. routine care), conducted through home visits. Sachets
      (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are:
      1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads
      to better development; 3) Integrated MNP plus early learning leads to better development
      through both additive and synergistic processes. Developmental evaluations and anthropometric
      measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood
      draws for micronutrient status are performed at baseline and endline. Morbidity measures are
      collected monthly using a morbidity form, modeled after the Demographic and Health Survey.

      The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC)
      (preschools). AWC are classified as high or low stimulation, based on an objective
      observational rating system of the physical environment of the preschools and teacher-child
      interactions. Preschools are categorized into high/low-quality based on median split,
      followed by random assignment of MNP/placebo nested within high/low-quality preschools. The
      hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and
      micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the
      quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The
      intervention has been modified to coincide with the academic term (September-May).
      Evaluations are conducted at baseline (September) and end-line (prior to May), with an
      8-month intervention period.
Project Grow Smart has two phases: an infant phase and a preschool phase. The design of the
      two phases differs, although both evaluate the impact of fortification with multiple
      micronutrient powders (MNP) vs. placebo on child development.

      In the infant phase, 6-14 month old infants are recruited and randomized into one of four
      cells to receive: placebo, placebo plus early learning, MNP alone, and MNP plus early
      learning (integrated intervention). Interventions are delivered through biweekly
      (twice/month) home visits by Village Level Workers. Families of all infants receive
      information on iron rich foods.

      The preschool phase is conducted in 22 Anganwadi Centers (AWC) (i.e., preschools). AWC
      quality is assessed, based on a 109-item observation scale, organized into 18 categories,
      based on two validated scales: Early Childhood Environment Rating Scale-Revised (ECERS-R) and
      HOME Inventory, modified to rate the quality of learning opportunities and teacher-child
      interactions. After training and establishing inter-rater reliability, two psychologists
      spend four hours in each preschool and independently complete the observation. Scores are
      summed and averaged. Based on a median split, preschools are categorized into
      high/low-quality with random assignment of MNP/placebo nested within high/low-quality
      preschools. Classifications are unknown by investigators, study team, or preschools.

      The preschool protocol has been modified to ensure that the trial coincides with the academic
      term (September-May) to avoid losing the oldest children who transfer to private or primary
      schools. Baseline evaluations are conducted in September and end-line evaluations are
      conducted prior to May. Mid-line evaluations have been eliminated. The intervention is
      delivered over 8 months. The MNP/placebo was supplied to preschools in identical packets of
      200 grams, including two measuring spoons of 1 and 0.5 grams. Each packet includes a
      manufacturer-assigned alphabetic code. AWC workers mix the MNP/placebo into the first bites
      of the preschoolers' mid-day meal. Mothers receive information on iron-rich food.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: The infant phase is a factorial design.
The preschool phase is a cluster-randomized trial (MNP/placebo nested within high/low-quality preschools).
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Infants: Change in cognitive, language, motor, and socio-emotional development
time frame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
description: Data on infants' cognitive, language, motor, and socio-emotional development will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation using the Mullens Scales of Early Learning.
measure: Preschoolers: Change in cognitive, language, motor, and socio-emotional development
time frame: Baseline and End-Point (8mo post BL)
description: Data on preschoolers' cognitive, language, motor, and socio-emotional development will be collected at baseline and the 8-month follow-up evaluation using the Mullens Scales of Early Learning.
measure: Infants: Change in micronutrient Status
time frame: Baseline and End-Point (12 mo post-baseline)
description: Data on infants' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 12-month follow-up evaluation.
measure: Preschoolers: Change in micronutrient Status
time frame: Baseline and End-Point (8mo post BL)
description: Data on preschoolers' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 8-month follow-up evaluation.
measure: Infants: Change in weight and height
time frame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
description: Data on infants' weight and height will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation
measure: Preschoolers: Change in weight and height
time frame: Baseline and End-Point (8mo post BL)
description: Data on preschoolers' weight and height will be collected at baseline and the 8-month follow-up evaluation
measure: Infants: Morbidity
time frame: Baseline and once a month (for 12mo post BL)
description: Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.
measure: Preschoolers: Morbidity
time frame: Baseline and once a month (for 8mo post BL)
description: Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.
arm group label: Infants: MNP
arm group type: Experimental
description: • Infants will receive sachets of multiple micronutrient powder (MNP) vs. placebo.
arm group label: Infants: Early Learning
arm group type: Experimental
description: • Infant will receive early learning messages delivered in the home by village level workers vs. routine care.
arm group label: Infants: No intervention
arm group type: No Intervention
description: Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).
Infant phase. Routine care - no early learning intervention
arm group label: Infants: MNP/Early Learning
arm group type: Experimental
description: Infants receive the MNP plus early learning intervention by receiving MNP sachets
Caregivers receive early learning messaged delivered at home biweekly for one year
arm group label: Preschoolers:MNP/High qual preschool
arm group type: Experimental
description: Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
Preschools that are classified as high quality preschools.
arm group label: Preschoolers:Placebo/High qual preschool
arm group type: No Intervention
description: Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
Preschools that are classified as high quality preschools.
arm group label: Preschoolers:MNP/Low qual preschool
arm group type: Experimental
description: Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
Preschools that are classified as low quality preschools.
arm group label: Preschoolers:Placebo/Low qual preschool
arm group type: No Intervention
description: Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).
Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
Preschools that are classified as low quality preschools.
intervention type: Dietary Supplement
intervention name: MNP
description: The formulation of the multiple micronutrient powder (MNP) was based on low micronutrient intake, low bioavailability of iron and zinc in the Indian diet, and current World Health Organization (WHO)and Indian recommendations regarding fortification and age-specific nutrient requirements. The MNP formulations were produced by a certified company in India and include: Iron, Vitamin A, Vitamin C, Folic Acid, Zinc, Vitamin B12 Vitamin B2, plus filler (maltodextrin). Placebo included riboflavin and maltodextrin.
arm group label: Infants: MNP
arm group label: Infants: MNP/Early Learning
arm group label: Preschoolers:MNP/High qual preschool
arm group label: Preschoolers:MNP/Low qual preschool
intervention type: Behavioral
intervention name: Early Learning
description: • Infant will benefit from interventions that are based on responsive parenting, whereby caregivers respond to children's cues, provide opportunities for exploration, and engage in nurturant and reciprocal communication.
arm group label: Infants: Early Learning
arm group label: Infants: MNP/Early Learning
other name: Care for Development
criteria: 
gender: All
minimum age: 6 Months
maximum age: 48 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Maureen M Black, PhD
role: Principal Investigator
affiliation: University of Maryland, Baltimore
last name: Madhavan K. Nair, PhD
role: Principal Investigator
affiliation: NATIONAL INSTITUTE OF NUTRITION
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Maureen Black
investigator title: Professor
mesh term: Malnutrition