<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/NCT01704105</url>
  </required_header>
  <id_info>
    <org_study_id>IPA-2012-KE</org_study_id>
    <secondary_id>2011-09-3654</secondary_id>
    <nct_id>NCT01704105</nct_id>
  </id_info>
  <brief_title>WASH Benefits Kenya</brief_title>
  <acronym>WASHB-Kenya</acronym>
  <official_title>WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovations for Poverty Action</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Innovations for Poverty Action</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the independent and combined effects of interventions&#xD;
      that improve sanitation, water quality, handwashing, and nutrition on child health and&#xD;
      development in the first years of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children in resource-poor settings are at risk of multiple episodes of diarrhea, enteric&#xD;
      infections, and environmental enteropathy, an inflammatory disorder of the intestines that&#xD;
      compromises nutrient absorption (1). In cross-sectional analyses, repeated episodes of&#xD;
      diarrhea and chronic environmental enteropathy in early childhood are associated with reduced&#xD;
      growth and cognitive function, and impaired school performance which can reduce income later&#xD;
      in life (2-8). Although more evidence is needed to establish causal links, repeated episodes&#xD;
      of childhood diarrhea and enteric infection may exact a long-run toll, perpetuating a cycle&#xD;
      of poverty and ill health.&#xD;
&#xD;
      Infection and inadequate diet are proximate risk factors for undernutrition and early life&#xD;
      growth faltering; the two processes likely act reciprocally in a vicious cycle that&#xD;
      perpetuates physiologic and metabolic deficits and increases the risk of mortality. Children&#xD;
      who exhibit growth faltering are more likely to have deficits in cognitive development and&#xD;
      long-term human capital, and are more likely to have children who also suffer from growth&#xD;
      deficits - perpetuating the cycle into the next generation.&#xD;
&#xD;
      There are two probable interdependent pathways that link enteric infections to child growth&#xD;
      and development. The first pathway includes repeated infections that lead to acute illness or&#xD;
      parasitic infection in the first years of life, which increase the risk of stunting and&#xD;
      subsequent cognitive deficits in childhood and later in life. The second pathway is through&#xD;
      subclinical environmental enteropathy.&#xD;
&#xD;
      There is limited evidence to demonstrate whether or not water quality, sanitation, and&#xD;
      handwashing (WASH) interventions can improve measures of environmental enteropathy, child&#xD;
      growth and development, and whether nutritional interventions could be enhanced if provided&#xD;
      concurrently with WASH interventions. To help fill this evidence gap, the WASH Benefits study&#xD;
      will deliver randomized interventions designed to reduce infection and improve nutrition, and&#xD;
      will measure intervention effects on child illness, growth and development. WASH Benefits&#xD;
      includes two, comparable but standalone trials in Bangladesh and Kenya that are registered&#xD;
      under separate protocols.&#xD;
&#xD;
      In Kenya, the study will include approximately 800 clusters, and each cluster will enroll&#xD;
      approximately 10 household compounds with pregnant women in their second or third trimester.&#xD;
      The study will randomize 100 clusters to each of 6 active intervention arms (water quality,&#xD;
      sanitation, handwashing, combined WSH, nutrition, nutrition+WSH), 200 clusters to a double&#xD;
      size active control arm, and 100 clusters to a single-sized passive control arm (measurement&#xD;
      pending future funding). Children born into the cohort will be followed for 2 years after the&#xD;
      intervention, with measurements at 12 and 24 months after intervention delivery. (anticipated&#xD;
      age range: 20 - 27 months old at the final measurement). At the 12- and 24-month follow-up&#xD;
      visits, the study will collect child anthropometric measurements and caregiver-reported&#xD;
      diarrhea. In the final visit the study will administer a test to measure child development&#xD;
      outcomes. The study will collect urine, blood, and stool specimens from a subsample of 1,500&#xD;
      children distributed across four arms of the study (Active Control, Combined WSH, Nutrition,&#xD;
      Nutrition+WSH) to measure biomarkers of gut function and intestinal parasitic infections at&#xD;
      the 12- and 24-month follow-up visits. In addition, the study will collect specimens (blood,&#xD;
      stool) from children 18 - 27 months old at baseline who are living in the same compound as&#xD;
      target children to test for intestinal parasitic infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>
    <masking_description>Analysts and lab technicians were masked to intervention status. Outcome collectors were not informed of intervention status, but could have inferred status from observing intervention hardware during household visits.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Length-for-Age Z-scores</measure>
    <time_frame>Measured 24 months after intervention</time_frame>
    <description>Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24 months after intervention. Measurement techniques follow the FANTA 2003 protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diarrhea Prevalence</measure>
    <time_frame>Measured 12 and 24 months after intervention</time_frame>
    <description>Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 12 and 24 months after intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length-for-Age Z-scores</measure>
    <time_frame>Measured 12 months after intervention</time_frame>
    <description>Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 12 months after intervention. Measurement techniques follow the FANTA 2003 protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stunting Prevalence</measure>
    <time_frame>Measured 24 months after intervention</time_frame>
    <description>Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24 months after intervention. Measurement techniques follow the FANTA 2003 protocol. Children with length-for-age Z-scores &lt; - 2 will be classified as stunted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enteropathy Biomarkers</measure>
    <time_frame>Measured 12- and 24 months after intervention</time_frame>
    <description>The lactulose / mannitol dual sugar permeability test will be administered to children. The ratio of the recovery of the two sugars in the urine will be used to calculate the L:M ratio, and we will compare groups using logged values of the ratio. We will measure myeloperoxidase, alpha 1-antitrypsin, and neopterin levels in the stool. We will additionally measure Total IgG antibody titers in the blood, and we will compare groups using logged values of the antibody levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASQ Child Development Scores</measure>
    <time_frame>Measured 24 months after intervention</time_frame>
    <description>Interviewers will administer a locally adapted version of the Ages and Stages Questionnaire (ASQ) to children after 24 months of intervention. The ASQ includes item sets of caregiver-reported milestones that measure child development in three separate domains (gross motor, communication, personal/social skills).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infection with ascaris, trichuris, hookworm, and giardia</measure>
    <time_frame>Measured 24 months after interventions began</time_frame>
    <description>Infection with soil transmitted helminths (ascaris, trichuris, hookworm) will be enumerated in stool collected from all index children and one older child per study compound. Giardia will also be measured in stool samples collected form these children. Prevalence and eggs per gram of feces will be recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin concentration and anemia</measure>
    <time_frame>Measured 24 months after interventions began</time_frame>
    <description>Hemoglobin concentrations will be measured using venous blood samples with a Hemocue 301 analyzer.</description>
  </other_outcome>
  <other_outcome>
    <measure>Micronutrient status, including iron, vitamin A, folate, and B12</measure>
    <time_frame>Measured 24 months after interventions began</time_frame>
    <description>Iron status will be assessed using the biomarkers of ferritin, soluble transferrin receptor (sTfR), and hepcidin. Vitamin A status will be assessed using retinol binding protein. Folate and B12 status will be measured using plasma folate and B12.</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">8246</enrollment>
  <condition>Malnutrition</condition>
  <condition>Diarrhea</condition>
  <condition>Child Development</condition>
  <arm_group>
    <arm_group_label>Water Quality</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sanitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Handwashing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition + Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>200 clusters, approximately 2,000 newborns. Village-level promoter will visit household and will strictly engage in recording the child's MUAC, which will also be conducted in all active comparator arms as well.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>100 clusters, approximately 1,000 newborns. No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Water Quality</intervention_name>
    <description>Hardware: Chlorine dispensers provided for free at communal water sources. Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on the treatment of drinking water for all children living in the household.</description>
    <arm_group_label>Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_label>Nutrition + Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_label>Water Quality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sanitation</intervention_name>
    <description>Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, and new or upgraded pit latrine for each study compound. Upgrades may include structural improvements, plastic slabs, and superstructure improvements.&#xD;
Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.</description>
    <arm_group_label>Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_label>Nutrition + Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_label>Sanitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Handwashing</intervention_name>
    <description>Hardware: Handwashing &quot;dual tippy tap&quot; stations, including jugs for clean and for soapy water. Handwashing stations will be stocked with soap for the duration of the trial.&#xD;
Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on handwashing with soap at critical times around food preparation, defecation, and contact with feces.</description>
    <arm_group_label>Combined Water, Sanitation, and Handwashing</arm_group_label>
    <arm_group_label>Handwashing</arm_group_label>
    <arm_group_label>Nutrition + Combined Water, Sanitation, and Handwashing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrition</intervention_name>
    <description>Supplement: Lipid-based Nutrient Supplement (LNS) twice daily from ages 6 to 24 months.&#xD;
Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices. General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old.</description>
    <arm_group_label>Nutrition</arm_group_label>
    <arm_group_label>Nutrition + Combined Water, Sanitation, and Handwashing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Study Population Description:&#xD;
&#xD;
        The subject population will be young children and their mothers/guardians living in several&#xD;
        contiguous districts of Western Province, in the rural areas outside the towns of Bungoma&#xD;
        and Kakamega. Communities must meet the following criteria:&#xD;
&#xD;
          -  Located in a rural area (defined as villages with &lt;25% residents living in rental&#xD;
             houses, &lt;2 gas/petrol stations and &lt;10 shops)&#xD;
&#xD;
          -  Not enrolled in ongoing WASH or nutrition programs&#xD;
&#xD;
          -  No chlorine dispensers at water sources installed by programs separate from the&#xD;
             present study&#xD;
&#xD;
          -  Majority (&gt;80%) of households do not have access to piped water into the home&#xD;
&#xD;
          -  At least six eligible pregnant women in the cluster at baseline.&#xD;
&#xD;
        From enrolled communities, household compounds will be enrolled if they meet the following&#xD;
        criteria.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. One or more women who self-identify as pregnant at the time of the baseline survey&#xD;
&#xD;
          2. The woman plans to stay in the community for the next 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) The study excludes households who do not own their home to help mitigate attrition&#xD;
        during follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clair Null, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Innovations for Poverty Action and Mathematica Policy Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christine Stewart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amy Pickering, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innovations for Poverty Action, Kenya</name>
      <address>
        <city>Kisumu</city>
        <state>P.O Box 2663</state>
        <zip>40100</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <link>
    <url>http://www.washbenefits.net</url>
    <description>Click here for more information about this study</description>
  </link>
  <link>
    <url>http://www.clinicaltrials.gov/ct2/show/NCT01590095</url>
    <description>Related protocol</description>
  </link>
  <reference>
    <citation>Haghighi P, Wolf PL. Tropical sprue and subclinical enteropathy: a vision for the nineties. Crit Rev Clin Lab Sci. 1997;34(4):313-41. doi: 10.3109/10408369708998096.</citation>
    <PMID>9288443</PMID>
  </reference>
  <reference>
    <citation>Borghi J, Guinness L, Ouedraogo J, Curtis V. Is hygiene promotion cost-effective? A case study in Burkina Faso. Trop Med Int Health. 2002 Nov;7(11):960-9. doi: 10.1046/j.1365-3156.2002.00954.x.</citation>
    <PMID>12390603</PMID>
  </reference>
  <reference>
    <citation>Alderman H, Hoddinott J, Kinsey B. Long term consequences of early childhood malnutrition. Oxford Economic Papers-New Series 2006;58:450-474.</citation>
  </reference>
  <reference>
    <citation>Checkley W, Buckley G, Gilman RH, Assis AM, Guerrant RL, Morris SS, Molbak K, Valentiner-Branth P, Lanata CF, Black RE; Childhood Malnutrition and Infection Network. Multi-country analysis of the effects of diarrhoea on childhood stunting. Int J Epidemiol. 2008 Aug;37(4):816-30. doi: 10.1093/ije/dyn099. Epub 2008 Jun 20.</citation>
    <PMID>18567626</PMID>
  </reference>
  <reference>
    <citation>Lorntz B, Soares AM, Moore SR, Pinkerton R, Gansneder B, Bovbjerg VE, Guyatt H, Lima AM, Guerrant RL. Early childhood diarrhea predicts impaired school performance. Pediatr Infect Dis J. 2006 Jun;25(6):513-20. doi: 10.1097/01.inf.0000219524.64448.90.</citation>
    <PMID>16732149</PMID>
  </reference>
  <reference>
    <citation>Niehaus MD, Moore SR, Patrick PD, Derr LL, Lorntz B, Lima AA, Guerrant RL. Early childhood diarrhea is associated with diminished cognitive function 4 to 7 years later in children in a northeast Brazilian shantytown. Am J Trop Med Hyg. 2002 May;66(5):590-3. doi: 10.4269/ajtmh.2002.66.590.</citation>
    <PMID>12201596</PMID>
  </reference>
  <reference>
    <citation>Petri WA Jr, Miller M, Binder HJ, Levine MM, Dillingham R, Guerrant RL. Enteric infections, diarrhea, and their impact on function and development. J Clin Invest. 2008 Apr;118(4):1277-90. doi: 10.1172/JCI34005.</citation>
    <PMID>18382740</PMID>
  </reference>
  <reference>
    <citation>Boissiere M, Knight JB, Sabot RH. Earnings, schooling, ability, and cognitive skills. American Economic Review 1985;75:1016-1030.</citation>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>July 10, 2018</last_update_submitted>
  <last_update_submitted_qc>July 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Innovations for Poverty Action</investigator_affiliation>
    <investigator_full_name>Clair Null</investigator_full_name>
    <investigator_title>Research Affiliate</investigator_title>
  </responsible_party>
  <keyword>Chlorine water treatment</keyword>
  <keyword>Point-of-use water treatment</keyword>
  <keyword>Household water treatment with safe storage</keyword>
  <keyword>Handwashing with soap</keyword>
  <keyword>Hand hygiene</keyword>
  <keyword>Latrines</keyword>
  <keyword>Water</keyword>
  <keyword>Sanitation</keyword>
  <keyword>Handwashing</keyword>
  <keyword>Breast Feeding</keyword>
  <keyword>Complementary Feeding</keyword>
  <keyword>Micronutrients</keyword>
  <keyword>Malnutrition</keyword>
  <keyword>Nutrition Disorders</keyword>
  <keyword>Diarrhea</keyword>
  <keyword>Child Development</keyword>
  <keyword>Child potties</keyword>
  <keyword>Point-of-use fortification</keyword>
  <keyword>Lipid-based nutrient supplement</keyword>
  <keyword>Exclusive breastfeeding</keyword>
  <keyword>Environmental enteropathy</keyword>
  <keyword>Tropical enteropathy</keyword>
  <keyword>Gut function</keyword>
  <keyword>Intestinal parasitic infection</keyword>
  <keyword>Soil transmitted helminths</keyword>
  <keyword>Intestinal protozoans</keyword>
  <keyword>Antibody response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Diarrhea</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/NCT01704105
org study id: IPA-2012-KE
secondary id: 2011-09-3654
nct id: NCT01704105
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to measure the independent and combined effects of interventions
      that improve sanitation, water quality, handwashing, and nutrition on child health and
      development in the first years of life.
Children in resource-poor settings are at risk of multiple episodes of diarrhea, enteric
      infections, and environmental enteropathy, an inflammatory disorder of the intestines that
      compromises nutrient absorption (1). In cross-sectional analyses, repeated episodes of
      diarrhea and chronic environmental enteropathy in early childhood are associated with reduced
      growth and cognitive function, and impaired school performance which can reduce income later
      in life (2-8). Although more evidence is needed to establish causal links, repeated episodes
      of childhood diarrhea and enteric infection may exact a long-run toll, perpetuating a cycle
      of poverty and ill health.

      Infection and inadequate diet are proximate risk factors for undernutrition and early life
      growth faltering; the two processes likely act reciprocally in a vicious cycle that
      perpetuates physiologic and metabolic deficits and increases the risk of mortality. Children
      who exhibit growth faltering are more likely to have deficits in cognitive development and
      long-term human capital, and are more likely to have children who also suffer from growth
      deficits - perpetuating the cycle into the next generation.

      There are two probable interdependent pathways that link enteric infections to child growth
      and development. The first pathway includes repeated infections that lead to acute illness or
      parasitic infection in the first years of life, which increase the risk of stunting and
      subsequent cognitive deficits in childhood and later in life. The second pathway is through
      subclinical environmental enteropathy.

      There is limited evidence to demonstrate whether or not water quality, sanitation, and
      handwashing (WASH) interventions can improve measures of environmental enteropathy, child
      growth and development, and whether nutritional interventions could be enhanced if provided
      concurrently with WASH interventions. To help fill this evidence gap, the WASH Benefits study
      will deliver randomized interventions designed to reduce infection and improve nutrition, and
      will measure intervention effects on child illness, growth and development. WASH Benefits
      includes two, comparable but standalone trials in Bangladesh and Kenya that are registered
      under separate protocols.

      In Kenya, the study will include approximately 800 clusters, and each cluster will enroll
      approximately 10 household compounds with pregnant women in their second or third trimester.
      The study will randomize 100 clusters to each of 6 active intervention arms (water quality,
      sanitation, handwashing, combined WSH, nutrition, nutrition+WSH), 200 clusters to a double
      size active control arm, and 100 clusters to a single-sized passive control arm (measurement
      pending future funding). Children born into the cohort will be followed for 2 years after the
      intervention, with measurements at 12 and 24 months after intervention delivery. (anticipated
      age range: 20 - 27 months old at the final measurement). At the 12- and 24-month follow-up
      visits, the study will collect child anthropometric measurements and caregiver-reported
      diarrhea. In the final visit the study will administer a test to measure child development
      outcomes. The study will collect urine, blood, and stool specimens from a subsample of 1,500
      children distributed across four arms of the study (Active Control, Combined WSH, Nutrition,
      Nutrition+WSH) to measure biomarkers of gut function and intestinal parasitic infections at
      the 12- and 24-month follow-up visits. In addition, the study will collect specimens (blood,
      stool) from children 18 - 27 months old at baseline who are living in the same compound as
      target children to test for intestinal parasitic infections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
masking description: Analysts and lab technicians were masked to intervention status. Outcome collectors were not informed of intervention status, but could have inferred status from observing intervention hardware during household visits.
measure: Length-for-Age Z-scores
time frame: Measured 24 months after intervention
description: Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24 months after intervention. Measurement techniques follow the FANTA 2003 protocol.
measure: Diarrhea Prevalence
time frame: Measured 12 and 24 months after intervention
description: Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 12 and 24 months after intervention.
measure: Length-for-Age Z-scores
time frame: Measured 12 months after intervention
description: Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 12 months after intervention. Measurement techniques follow the FANTA 2003 protocol
measure: Stunting Prevalence
time frame: Measured 24 months after intervention
description: Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24 months after intervention. Measurement techniques follow the FANTA 2003 protocol. Children with length-for-age Z-scores < - 2 will be classified as stunted.
measure: Enteropathy Biomarkers
time frame: Measured 12- and 24 months after intervention
description: The lactulose / mannitol dual sugar permeability test will be administered to children. The ratio of the recovery of the two sugars in the urine will be used to calculate the L:M ratio, and we will compare groups using logged values of the ratio. We will measure myeloperoxidase, alpha 1-antitrypsin, and neopterin levels in the stool. We will additionally measure Total IgG antibody titers in the blood, and we will compare groups using logged values of the antibody levels.
measure: ASQ Child Development Scores
time frame: Measured 24 months after intervention
description: Interviewers will administer a locally adapted version of the Ages and Stages Questionnaire (ASQ) to children after 24 months of intervention. The ASQ includes item sets of caregiver-reported milestones that measure child development in three separate domains (gross motor, communication, personal/social skills).
measure: Infection with ascaris, trichuris, hookworm, and giardia
time frame: Measured 24 months after interventions began
description: Infection with soil transmitted helminths (ascaris, trichuris, hookworm) will be enumerated in stool collected from all index children and one older child per study compound. Giardia will also be measured in stool samples collected form these children. Prevalence and eggs per gram of feces will be recorded.
measure: Hemoglobin concentration and anemia
time frame: Measured 24 months after interventions began
description: Hemoglobin concentrations will be measured using venous blood samples with a Hemocue 301 analyzer.
measure: Micronutrient status, including iron, vitamin A, folate, and B12
time frame: Measured 24 months after interventions began
description: Iron status will be assessed using the biomarkers of ferritin, soluble transferrin receptor (sTfR), and hepcidin. Vitamin A status will be assessed using retinol binding protein. Folate and B12 status will be measured using plasma folate and B12.
arm group label: Water Quality
arm group type: Active Comparator
description: 100 clusters, approximately 1,000 newborns
arm group label: Sanitation
arm group type: Active Comparator
description: 100 clusters, approximately 1,000 newborns
arm group label: Handwashing
arm group type: Active Comparator
description: 100 clusters, approximately 1,000 newborns
arm group label: Combined Water, Sanitation, and Handwashing
arm group type: Active Comparator
description: 100 clusters, approximately 1,000 newborns
arm group label: Nutrition
arm group type: Active Comparator
description: 100 clusters, approximately 1,000 newborns
arm group label: Nutrition + Combined Water, Sanitation, and Handwashing
arm group type: Active Comparator
description: 100 clusters, approximately 1,000 newborns
arm group label: Active control arm
arm group type: No Intervention
description: 200 clusters, approximately 2,000 newborns. Village-level promoter will visit household and will strictly engage in recording the child's MUAC, which will also be conducted in all active comparator arms as well.
arm group label: Passive control arm
arm group type: No Intervention
description: 100 clusters, approximately 1,000 newborns. No intervention.
intervention type: Behavioral
intervention name: Water Quality
description: Hardware: Chlorine dispensers provided for free at communal water sources. Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on the treatment of drinking water for all children living in the household.
arm group label: Combined Water, Sanitation, and Handwashing
arm group label: Nutrition + Combined Water, Sanitation, and Handwashing
arm group label: Water Quality
intervention type: Behavioral
intervention name: Sanitation
description: Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, and new or upgraded pit latrine for each study compound. Upgrades may include structural improvements, plastic slabs, and superstructure improvements.
Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
arm group label: Combined Water, Sanitation, and Handwashing
arm group label: Nutrition + Combined Water, Sanitation, and Handwashing
arm group label: Sanitation
intervention type: Behavioral
intervention name: Handwashing
description: Hardware: Handwashing "dual tippy tap" stations, including jugs for clean and for soapy water. Handwashing stations will be stocked with soap for the duration of the trial.
Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on handwashing with soap at critical times around food preparation, defecation, and contact with feces.
arm group label: Combined Water, Sanitation, and Handwashing
arm group label: Handwashing
arm group label: Nutrition + Combined Water, Sanitation, and Handwashing
intervention type: Dietary Supplement
intervention name: Nutrition
description: Supplement: Lipid-based Nutrient Supplement (LNS) twice daily from ages 6 to 24 months.
Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices. General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old.
arm group label: Nutrition
arm group label: Nutrition + Combined Water, Sanitation, and Handwashing
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clair Null, PhD
role: Principal Investigator
affiliation: Innovations for Poverty Action and Mathematica Policy Research
last name: Christine Stewart, PhD
role: Principal Investigator
affiliation: University of California, Davis
last name: Amy Pickering, PhD
role: Principal Investigator
affiliation: Tufts University
facility: 
country: Kenya
url: http://www.washbenefits.net
description: Click here for more information about this study
url: http://www.clinicaltrials.gov/ct2/show/NCT01590095
description: Related protocol
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responsible party type: Principal Investigator
investigator affiliation: Innovations for Poverty Action
investigator full name: Clair Null
investigator title: Research Affiliate
mesh term: Malnutrition
mesh term: Diarrhea