WASH Benefits Bangladesh

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01590095
First received: April 30, 2012
Last updated: August 29, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention
Malnutrition
Diarrhea
Child Development
Behavioral: Water quality
Behavioral: Sanitation
Behavioral: Hand washing
Behavioral: Water quality, Sanitation, Hand washing (Combined WASH)
Behavioral: Nutrition
Behavioral: Nutrition, Water quality, Sanitation, Hand washing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Length-for-Age Z-scores [ Time Frame: Measured 24 months after intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Length-for-Age Z-scores [ Time Frame: Measured 12 months after intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 5040
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Water quality
90 clusters, approx. 720 newborns
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.

Active Comparator: Sanitation
90 clusters, approx. 720 newborns
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.
Active Comparator: Hand washing
90 clusters, approx. 720 newborns
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.

Active Comparator: Combined WASH
90 clusters, approx. 720 newborns
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.

Active Comparator: Nutrition
90 clusters, approx. 720 newborns
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.

Active Comparator: Nutrition + Combined WASH
90 clusters, approx. 720 newborns
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.
No Intervention: Non-intervention
180 clusters, approx. 1,440 newborns

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.

  Eligibility

Ages Eligible for Study:   up to 63 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590095

Locations
Bangladesh
Dr. Leanne Unicomb
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of California, Berkeley
University of California, Davis
Stanford University
Emory University
Innovations for Poverty Action
Investigators
Principal Investigator: Stephen P Luby, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01590095     History of Changes
Other Study ID Numbers: PR-11063, 2011-09-3652 (UC Berkeley)
Study First Received: April 30, 2012
Last Updated: August 29, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Chlorine water treatment
Point-of-use water treatment
Household water treatment with safe storage
Hand washing with soap
Hand hygiene
Latrines
Child potties
Point-of-use fortification
Lipid-based nutrient supplement
Environmental enteropathy
Tropical enteropathy
Gut function
Intestinal parasitic infection
Soil transmitted helminths
Intestinal protozoans
Antibody response
Water
Sanitation
Hand washing
Breast Feeding
Complementary Feeding
Micronutrients
Malnutrition
Nutrition Disorders
Diarrhea
Child Development

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014