<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/NCT01715038</url>
  </required_header>
  <id_info>
    <org_study_id>252233</org_study_id>
    <secondary_id>PR-10044</secondary_id>
    <nct_id>NCT01715038</nct_id>
  </id_info>
  <brief_title>Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh</brief_title>
  <acronym>RDNS</acronym>
  <official_title>Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Family Health International 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Mission Prayer League (LAMB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The program effectiveness study aims to assess the effect of a lipid-based nutrition&#xD;
      supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for&#xD;
      improving maternal nutritional status during pregnancy and lactation (LNS only), and&#xD;
      preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a cluster-randomized controlled trial with four study &quot;arms&quot;, implemented&#xD;
      within the context of the Community Health and Development Program (CHDP) run by the World&#xD;
      Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data&#xD;
      collection is longitudinal, starting with the identification of women in early pregnancy who&#xD;
      are eligible to enter the study, and continuing, with follow-up of the child, until 24 months&#xD;
      post-partum. A final follow-up visit will occur when the child is 36 months old to update&#xD;
      contact information; no outcomes data will be collected at that final visit. The&#xD;
      investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and&#xD;
      lactation on maternal health and nutrition outcomes (including anthropometric and&#xD;
      micronutrient status), morbidity and birth outcomes in comparison to mothers who receive&#xD;
      iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating&#xD;
      the effect of three different home-fortification approaches (arms a-c, below) on child health&#xD;
      and nutrition outcomes including anthropometric status, micronutrient status, anemia, and&#xD;
      motor and cognitive development, in comparison to a control arm not receiving a home&#xD;
      fortification intervention.&#xD;
&#xD;
      Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP&#xD;
      interventions as part of the CHDP compared to standard CHDP program delivery will be&#xD;
      documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by&#xD;
      selected caregivers and male heads of households will be assessed at baseline and again at&#xD;
      various points during the intervention period.&#xD;
&#xD;
      A process evaluation of the LNS and MNP interventions, and of the services provided to the&#xD;
      control group, within the CHDP will be conducted to: 1) Document and evaluate the processes&#xD;
      needed for implementation of interventions that provide a nutrient supplement such as LNS or&#xD;
      MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study&#xD;
      results and identify important facilitators and barriers to success of the nutrition&#xD;
      intervention, which can be used to improve the effectiveness of current CHDP programs and&#xD;
      future similar programs that include the scaling-up of LNS or MNP.&#xD;
&#xD;
      A post-intervention follow-up assessment for participants in the RDNS trial was added to the&#xD;
      study protocol in November 2015. The intervention stopped when the study children turned 24&#xD;
      months old, and follow-up visits to update contact information were conducted when the&#xD;
      children turned 36 months old. Thereafter, when the study children are between 40 and 52&#xD;
      months old, the follow-up assessment includes anthropometric and cognitive development&#xD;
      assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and&#xD;
      buccal swab samples at the local clinics; for the mothers the follow-up includes&#xD;
      anthropometric measurements, measurement of blood pressure and collection of fasting blood&#xD;
      samples (finger prick). The follow-up also includes anthropometric measurements of the&#xD;
      younger siblings, as well as a home visit to collect information on socioeconomic status,&#xD;
      food security, hospitalizations of mother or child, developmental stimulation in the home,&#xD;
      child food preferences and retrospective perceptions about the trial interventions.&#xD;
&#xD;
      Follow-up outcomes:&#xD;
&#xD;
      Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height.&#xD;
      Hemoglobin, anemia, blood pressure, blood lipids, HbA1C.&#xD;
&#xD;
      Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm&#xD;
      fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial),&#xD;
      executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24&#xD;
      months of age. Preferences for sweet and fatty foods.&#xD;
&#xD;
      Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Birth weight</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements).</time_frame>
    <description>Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Birth length</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child linear growth status at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Linear growth (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in maternal weight between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 and 36 weeks of gestation</time_frame>
    <description>Gestational weight gain from enrollment (by 20 weeks of gestation) through 36 weeks of gestation (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-eclampsia</measure>
    <time_frame>36 weeks of gestation</time_frame>
    <description>Prevalence of pre-eclampsia (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of gestation</measure>
    <time_frame>Day 0</time_frame>
    <description>Duration of gestation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-term delivery</measure>
    <time_frame>Day 0</time_frame>
    <description>Prevalence of pre-term delivery (delivery at &lt;37 gestational weeks) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low birth weight</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>Prevalence of low birth weight (birth weight &lt; 2500 g) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Small for gestational age (SGA)</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>Prevalence of SGA (birth weight &lt; 10th percentile) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn stunting</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>Prevalence of newborn stunting (length-for-age z-score &lt;-2) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI z score at birth</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>BMI z score at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference (HC) at birth</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>Head circumference at birth of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Small head size at birth</measure>
    <time_frame>Within 48 hours (or back calculated from later measurements)</time_frame>
    <description>Prevalence of small head size (HC-z-score &lt;-2) at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal weight between 42 d and 6 mo postpartum</measure>
    <time_frame>Between 42 d and 6 mo postpartum</time_frame>
    <description>Postpartum weight change from 42 days through 6 mo postpartum (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), for time of year when outcome was assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal iodine status between baseline and 6 mo postpartum</measure>
    <time_frame>Between 10-20 weeks of gestation and 6 months postpartum</time_frame>
    <description>Prevalence of iodine deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal iron status between baseline and 6 months postpartum</measure>
    <time_frame>Between 10-20 weeks of gestation and 6 months postpartum</time_frame>
    <description>Prevalence of iron deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal iron-deficiency anemia between baseline and 6 months postpartum</measure>
    <time_frame>Between 10-20 weeks of gestation and 6 months postpartum</time_frame>
    <description>Prevalence of iron-deficiency anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal anemia between baseline and 6 months postpartum</measure>
    <time_frame>Between 10-20 weeks of gestation and 6 months postpartum</time_frame>
    <description>Prevalence of anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal vitamin A status between baseline and 6 months postpartum</measure>
    <time_frame>Between 10-20 weeks of gestation and 6 months postpartum</time_frame>
    <description>Prevalence of vitamin A deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal depressive symptoms between baseline and 6 months postpartum</measure>
    <time_frame>Between 10-20 weeks of gestation and 6 months postpartum</time_frame>
    <description>Prevalence of depression during lactation (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child hemoglobin concentration at 18 months of age</measure>
    <time_frame>18 months</time_frame>
    <description>Hemoglobin concentration (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child iron status at 18 months of age</measure>
    <time_frame>18 months</time_frame>
    <description>Prevalence of iron deficiency (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child vitamin A status at 18 months of age</measure>
    <time_frame>18 months</time_frame>
    <description>Prevalence of vitamin A deficiency (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child anemia status at 18 months of age</measure>
    <time_frame>18 months</time_frame>
    <description>Prevalence of anemia in children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child iron-deficiency anemia status at 18 months of age</measure>
    <time_frame>18 months</time_frame>
    <description>Prevalence of iron-deficiency anemia in children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wasting at 24 months of age</measure>
    <time_frame>24 months</time_frame>
    <description>Prevalence of wasting (weight-for-length z-score &lt;-2) in children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference at 24 months of age</measure>
    <time_frame>24 months</time_frame>
    <description>Head circumference of children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stunting at 24 months of age</measure>
    <time_frame>24 months</time_frame>
    <description>Prevalence of stunting (length-for-age z-score &lt;-2) in children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child motor development at 24 months of age</measure>
    <time_frame>24 months</time_frame>
    <description>Motor development of children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child cognitive development at 24 months of age</measure>
    <time_frame>24 months</time_frame>
    <description>Cognitive development of children (the &quot;comprehensive&quot; LNS approach vs. the &quot;child-only&quot; LNS approach vs. &quot;child-only&quot; MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in maternal hemoglobin concentration between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Hemoglobin concentration during pregnancy (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: hemoglobin baseline value, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maternal iodine status between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Prevalence of iodine deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maternal depressive symptoms between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Prevalence of depression during pregnancy (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maternal iron status between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Prevalence of iron deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maternal vitamin A status between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Prevalence of vitamin A deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maternal anemia between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Prevalence of anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maternal iron-deficiency anemia between baseline and 36 wk gestation</measure>
    <time_frame>Between 12-20 weeks and 36 weeks of gestation</time_frame>
    <description>Prevalence of iron-deficiency anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron-deficiency anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">4011</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Comprehensive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Comprehensive&quot; LNS: LNS-PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks gestation and ending at 6 months post-partum) and LNS developed for infants and young children (LNS-child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e., from 6-24 months of age).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child-only LNS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Child-only&quot; LNS: Daily LNS-child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child-only MNP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Child-only&quot; MNP: Daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: IFA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control: No additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>LNS-PLW</intervention_name>
    <description>Dietary supplement: Lipid-based nutrient supplement&#xD;
Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW)&#xD;
Daily dose of LNS-PLW will be 20 g, packaged in one sachet</description>
    <arm_group_label>Comprehensive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>LNS-Child</intervention_name>
    <description>Dietary supplement: Lipid-based nutrient supplement&#xD;
Lipid-based nutrient supplement for infants and young children (LNS-Child)&#xD;
Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets</description>
    <arm_group_label>Child-only LNS</arm_group_label>
    <arm_group_label>Comprehensive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MNP</intervention_name>
    <description>Dietary supplement: Micronutrient powder&#xD;
Micronutrient powder for infants and young children (MNP)&#xD;
The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet.</description>
    <arm_group_label>Child-only MNP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>IFA</intervention_name>
    <description>Dietary supplement: Iron and folic acid nutrient supplement&#xD;
Iron-folic acid tablets for pregnant and lactating women&#xD;
Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid</description>
    <arm_group_label>Child-only LNS</arm_group_label>
    <arm_group_label>Child-only MNP</arm_group_label>
    <arm_group_label>Control: IFA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age ≤ 20 weeks&#xD;
&#xD;
          -  Planning to remain in the study area during pregnancy and the following three years&#xD;
             (i.e., a permanent resident of the study area)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy identified and registered in the CHDP program before the beginning of the&#xD;
             enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn G Dewey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LAMB</name>
      <address>
        <city>Parbatipur</city>
        <state>Rangpur and Dinajpur Districts</state>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malnutrition</keyword>
  <keyword>stunting</keyword>
  <keyword>LNS</keyword>
  <keyword>micronutrient powder</keyword>
  <keyword>hemoglobin</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/NCT01715038
org study id: 252233
secondary id: PR-10044
nct id: NCT01715038
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The program effectiveness study aims to assess the effect of a lipid-based nutrition
      supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for
      improving maternal nutritional status during pregnancy and lactation (LNS only), and
      preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.
This study is a cluster-randomized controlled trial with four study "arms", implemented
      within the context of the Community Health and Development Program (CHDP) run by the World
      Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data
      collection is longitudinal, starting with the identification of women in early pregnancy who
      are eligible to enter the study, and continuing, with follow-up of the child, until 24 months
      post-partum. A final follow-up visit will occur when the child is 36 months old to update
      contact information; no outcomes data will be collected at that final visit. The
      investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and
      lactation on maternal health and nutrition outcomes (including anthropometric and
      micronutrient status), morbidity and birth outcomes in comparison to mothers who receive
      iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating
      the effect of three different home-fortification approaches (arms a-c, below) on child health
      and nutrition outcomes including anthropometric status, micronutrient status, anemia, and
      motor and cognitive development, in comparison to a control arm not receiving a home
      fortification intervention.

      Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP
      interventions as part of the CHDP compared to standard CHDP program delivery will be
      documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by
      selected caregivers and male heads of households will be assessed at baseline and again at
      various points during the intervention period.

      A process evaluation of the LNS and MNP interventions, and of the services provided to the
      control group, within the CHDP will be conducted to: 1) Document and evaluate the processes
      needed for implementation of interventions that provide a nutrient supplement such as LNS or
      MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study
      results and identify important facilitators and barriers to success of the nutrition
      intervention, which can be used to improve the effectiveness of current CHDP programs and
      future similar programs that include the scaling-up of LNS or MNP.

      A post-intervention follow-up assessment for participants in the RDNS trial was added to the
      study protocol in November 2015. The intervention stopped when the study children turned 24
      months old, and follow-up visits to update contact information were conducted when the
      children turned 36 months old. Thereafter, when the study children are between 40 and 52
      months old, the follow-up assessment includes anthropometric and cognitive development
      assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and
      buccal swab samples at the local clinics; for the mothers the follow-up includes
      anthropometric measurements, measurement of blood pressure and collection of fasting blood
      samples (finger prick). The follow-up also includes anthropometric measurements of the
      younger siblings, as well as a home visit to collect information on socioeconomic status,
      food security, hospitalizations of mother or child, developmental stimulation in the home,
      child food preferences and retrospective perceptions about the trial interventions.

      Follow-up outcomes:

      Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height.
      Hemoglobin, anemia, blood pressure, blood lipids, HbA1C.

      Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm
      fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial),
      executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24
      months of age. Preferences for sweet and fatty foods.

      Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Birth weight
time frame: Within 48 hours (or back calculated from later measurements).
description: Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Birth length
time frame: Within 48 hours (or back calculated from later measurements)
description: Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child linear growth status at 24 months
time frame: 24 months
description: Linear growth (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Change in maternal weight between baseline and 36 wk gestation
time frame: Between 12-20 and 36 weeks of gestation
description: Gestational weight gain from enrollment (by 20 weeks of gestation) through 36 weeks of gestation (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Pre-eclampsia
time frame: 36 weeks of gestation
description: Prevalence of pre-eclampsia (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Duration of gestation
time frame: Day 0
description: Duration of gestation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Pre-term delivery
time frame: Day 0
description: Prevalence of pre-term delivery (delivery at <37 gestational weeks) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Low birth weight
time frame: Within 48 hours (or back calculated from later measurements)
description: Prevalence of low birth weight (birth weight < 2500 g) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Small for gestational age (SGA)
time frame: Within 48 hours (or back calculated from later measurements)
description: Prevalence of SGA (birth weight < 10th percentile) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Newborn stunting
time frame: Within 48 hours (or back calculated from later measurements)
description: Prevalence of newborn stunting (length-for-age z-score <-2) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: BMI z score at birth
time frame: Within 48 hours (or back calculated from later measurements)
description: BMI z score at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Head circumference (HC) at birth
time frame: Within 48 hours (or back calculated from later measurements)
description: Head circumference at birth of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Small head size at birth
time frame: Within 48 hours (or back calculated from later measurements)
description: Prevalence of small head size (HC-z-score <-2) at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Change in maternal weight between 42 d and 6 mo postpartum
time frame: Between 42 d and 6 mo postpartum
description: Postpartum weight change from 42 days through 6 mo postpartum (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), for time of year when outcome was assessed
measure: Change in maternal iodine status between baseline and 6 mo postpartum
time frame: Between 10-20 weeks of gestation and 6 months postpartum
description: Prevalence of iodine deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal iron status between baseline and 6 months postpartum
time frame: Between 10-20 weeks of gestation and 6 months postpartum
description: Prevalence of iron deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal iron-deficiency anemia between baseline and 6 months postpartum
time frame: Between 10-20 weeks of gestation and 6 months postpartum
description: Prevalence of iron-deficiency anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal anemia between baseline and 6 months postpartum
time frame: Between 10-20 weeks of gestation and 6 months postpartum
description: Prevalence of anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal vitamin A status between baseline and 6 months postpartum
time frame: Between 10-20 weeks of gestation and 6 months postpartum
description: Prevalence of vitamin A deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal depressive symptoms between baseline and 6 months postpartum
time frame: Between 10-20 weeks of gestation and 6 months postpartum
description: Prevalence of depression during lactation (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Child hemoglobin concentration at 18 months of age
time frame: 18 months
description: Hemoglobin concentration (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child iron status at 18 months of age
time frame: 18 months
description: Prevalence of iron deficiency (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child vitamin A status at 18 months of age
time frame: 18 months
description: Prevalence of vitamin A deficiency (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child anemia status at 18 months of age
time frame: 18 months
description: Prevalence of anemia in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child iron-deficiency anemia status at 18 months of age
time frame: 18 months
description: Prevalence of iron-deficiency anemia in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Wasting at 24 months of age
time frame: 24 months
description: Prevalence of wasting (weight-for-length z-score <-2) in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Head circumference at 24 months of age
time frame: 24 months
description: Head circumference of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Stunting at 24 months of age
time frame: 24 months
description: Prevalence of stunting (length-for-age z-score <-2) in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child motor development at 24 months of age
time frame: 24 months
description: Motor development of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Child cognitive development at 24 months of age
time frame: 24 months
description: Cognitive development of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
measure: Change in maternal hemoglobin concentration between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Hemoglobin concentration during pregnancy (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: hemoglobin baseline value, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal iodine status between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Prevalence of iodine deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal depressive symptoms between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Prevalence of depression during pregnancy (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal iron status between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Prevalence of iron deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal vitamin A status between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Prevalence of vitamin A deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal anemia between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Prevalence of anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
measure: Change in maternal iron-deficiency anemia between baseline and 36 wk gestation
time frame: Between 12-20 weeks and 36 weeks of gestation
description: Prevalence of iron-deficiency anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron-deficiency anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
arm group label: Comprehensive
arm group type: Experimental
description: "Comprehensive" LNS: LNS-PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks gestation and ending at 6 months post-partum) and LNS developed for infants and young children (LNS-child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e., from 6-24 months of age).
arm group label: Child-only LNS
arm group type: Experimental
description: "Child-only" LNS: Daily LNS-child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.
arm group label: Child-only MNP
arm group type: Experimental
description: "Child-only" MNP: Daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.
arm group label: Control: IFA
arm group type: Active Comparator
description: Control: No additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.
intervention type: Dietary Supplement
intervention name: LNS-PLW
description: Dietary supplement: Lipid-based nutrient supplement
Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW)
Daily dose of LNS-PLW will be 20 g, packaged in one sachet
arm group label: Comprehensive
intervention type: Dietary Supplement
intervention name: LNS-Child
description: Dietary supplement: Lipid-based nutrient supplement
Lipid-based nutrient supplement for infants and young children (LNS-Child)
Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets
arm group label: Child-only LNS
arm group label: Comprehensive
intervention type: Dietary Supplement
intervention name: MNP
description: Dietary supplement: Micronutrient powder
Micronutrient powder for infants and young children (MNP)
The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet.
arm group label: Child-only MNP
intervention type: Dietary Supplement
intervention name: IFA
description: Dietary supplement: Iron and folic acid nutrient supplement
Iron-folic acid tablets for pregnant and lactating women
Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid
arm group label: Child-only LNS
arm group label: Child-only MNP
arm group label: Control: IFA
criteria: 
gender: All
minimum age: 6 Months
maximum age: 49 Years
healthy volunteers: No
last name: Kathryn G Dewey, PhD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Malnutrition