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WASH Benefits Bangladesh

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ClinicalTrials.gov Identifier: NCT01590095
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
University of California, Berkeley
University of California, Davis
Stanford University
Emory University
Innovations for Poverty Action
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE April 30, 2012
First Posted Date  ICMJE May 2, 2012
Last Update Posted Date August 20, 2019
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2013)
  • Length-for-Age Z-scores [ Time Frame: Measured 24 months after intervention ]
    Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
  • Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence [ Time Frame: Measured 12- and 24-months after intervention ]
    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-monthsafter intervention.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • Length-for-Age Z-scores [ Time Frame: Measured 24 months after intervention ]
    Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
  • Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence [ Time Frame: Measured 12- and 24-months after intervention ]
    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-monthsafter intervention.
  • ASQ Child Development Scores [ Time Frame: Measured 24 months after intervention ]
    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).
Change History Complete list of historical versions of study NCT01590095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2013)
  • Length-for-Age Z-scores [ Time Frame: Measured 12 months after intervention ]
    Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 12monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
  • Stunting Prevalence [ Time Frame: Measured 24 months after intervention ]
    Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol. Children with length-for-age Z-scores < - 2 will be classified as stunted.
  • Enteropathy Biomarkers [ Time Frame: Measured 12- and 24 months after intervention ]
    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 additionally measure Total IgG antibody titers in the blood, and we will compare groups using logged values of the antibody levels.
  • ASQ Child Development Scores [ Time Frame: Measured 24 months after intervention ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • Length-for-Age Z-scores [ Time Frame: Measured 12 months after intervention ]
    Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 12monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.
  • Stunting Prevalence [ Time Frame: Measured 24 months after intervention ]
    Child's recumbent length, standardized to Z-scores using the WHO 2006 growth standards, measured 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol. Children with length-for-age Z-scores < - 2 will be classified as stunted.
  • Enteropathy Biomarkers [ Time Frame: Measured 12- and 24 months after intervention ]
    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 additionally measure Total IgG antibody titers in the blood, and we will compare groups using logged values of the antibody levels.
Current Other Pre-specified Outcome Measures
 (submitted: July 2, 2018)
  • Infection with ascaris, trichuris, hookworm, and giardia [ Time Frame: Measured 24 months after interventions began ]
    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 from these children. Prevalence and eggs per gram of feces will be recorded.
  • Hemoglobin concentration and anemia [ Time Frame: Measured 24 months after interventions began ]
    Hemoglobin concentrations will be measured using venous blood samples with a Hemocue 301 analyzer
  • Micronutrient status, including iron, vitamin A, folate, and B12 [ Time Frame: Measured 24 months after interventions began ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WASH Benefits Bangladesh
Official Title  ICMJE WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary

Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.

Detailed Description

Detailed Description:

Infection and inadequate diet are proximate risk factors for under-nutrition 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 the 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 a subclinical condition called environmental enteropathy (EE).

There is limited evidence to demonstrate whether or not water quality, sanitation, and hand washing (WASH) interventions can improve measures of EE, 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 Bangladesh, the study will include 720 clusters, and each cluster will enroll 8 household compounds (baris) with pregnant women in their second or third trimester. The study will randomize 90 clusters to each of 6 active intervention arms (water quality, sanitation, hand washing, combined WSH, nutrition, nutrition+WSH), and 180 clusters to a standard practices non-intervention arm. 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 (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. At 24-months in all arms, the study will collect specimens stool from target children, children 18 - 27 months old at baseline, a school-aged child, and an adult who are living in the same compound as target children to test for intestinal parasitic infections. At 36-months in all arms, the study will collect specimens stool from target children, a school-aged child, and an adult who are living in the same compound as target children to test for intestinal parasitic infections.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Malnutrition
  • Diarrhea
  • Child Development
Intervention  ICMJE
  • Behavioral: Water quality

    Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.

    Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.

  • Behavioral: Sanitation
    Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly 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.
  • Behavioral: Hand washing

    Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.

    Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.

  • Behavioral: Water quality, Sanitation, Hand washing (Combined WASH)

    Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.

    Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly 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.

    Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.

  • Behavioral: Nutrition

    Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.

    Promotion: Local promoters will visit study compounds at least monthly 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.

  • Behavioral: Nutrition, Water quality, Sanitation, Hand washing
    Each of the interventions described above for Water Quality, Sanitation & Hand washing (Combined WASH) Plus the intervention described above for nutrition.
Study Arms  ICMJE
  • Active Comparator: Water quality
    90 clusters, approx. 720 newborns
    Intervention: Behavioral: Water quality
  • Active Comparator: Sanitation
    90 clusters, approx. 720 newborns
    Intervention: Behavioral: Sanitation
  • Active Comparator: Hand washing
    90 clusters, approx. 720 newborns
    Intervention: Behavioral: Hand washing
  • Active Comparator: Combined WASH
    90 clusters, approx. 720 newborns
    Intervention: Behavioral: Water quality, Sanitation, Hand washing (Combined WASH)
  • Active Comparator: Nutrition
    90 clusters, approx. 720 newborns
    Intervention: Behavioral: Nutrition
  • Active Comparator: Nutrition + Combined WASH
    90 clusters, approx. 720 newborns
    Intervention: Behavioral: Nutrition, Water quality, Sanitation, Hand washing
  • No Intervention: Non-intervention
    180 clusters, approx. 1,440 newborns
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2012)
5040
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

(1) Infants (target child) will be eligible to participate in the study if they are:

  1. They are in utero at the baseline survey
  2. Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment)

(2) Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if:

  1. They are < 36 months old at the baseline survey
  2. Their parents/guardians are planning to stay in the study village for the next 12 months

(3) Children 18 - 27 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if:

  1. They are 18 - 27 months old at the baseline survey
  2. Their parents/guardians are planning to stay in the study village for the next 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 63 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590095
Other Study ID Numbers  ICMJE PR-11063
2011-09-3652 (UC Berkeley)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE
  • University of California, Berkeley
  • University of California, Davis
  • Stanford University
  • Emory University
  • Innovations for Poverty Action
Investigators  ICMJE
Principal Investigator: Stephen P Luby, MD Stanford University
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP