Clinical trial NCT01590095: WASH Benefits Bangladesh
Official title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Diarrhea
Child Development
Keywords: 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
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: University of California, Davis
name: Stanford University
name: Emory University
name: Innovations for Poverty Action
First posted: 2012-05-02
Enrollment: 5040
Sex: ALL
Minimum age (years): 1
Maximum age (years): 63
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Length-for-Age Z-scores
timeFrame: Measured 24 months after intervention
measure: Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence
timeFrame: Measured 12- and 24-months after intervention
Secondary outcomes:
measure: Length-for-Age Z-scores
timeFrame: Measured 12 months after intervention
measure: Stunting Prevalence
timeFrame: Measured 24 months after intervention
measure: Enteropathy Biomarkers
timeFrame: Measured 12- and 24 months after intervention
measure: ASQ Child Development Scores
timeFrame: Measured 24 months after intervention
Other outcomes:
measure: Infection with ascaris, trichuris, hookworm, and giardia
timeFrame: Measured 24 months after interventions began
measure: Hemoglobin concentration and anemia
timeFrame: Measured 24 months after interventions began
measure: Micronutrient status, including iron, vitamin A, folate, and B12
timeFrame: Measured 24 months after interventions began
Locations:
city: Dhaka
country: Bangladesh
facility: Dr. Mahbubur Rahman
Study officials:
affiliation: Stanford University
name: Stephen P Luby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Contreras JD, Islam M, Mertens A, Pickering AJ, Arnold BF, Benjamin-Chung J, Hubbard AE, Rahman M, Unicomb L, Luby SP, Colford JM Jr, Ercumen A. Evaluation of an on-site sanitation intervention against childhood diarrhea and acute respiratory infection 1 to 3.5 years after implementation: Extended follow-up of a cluster-randomized controlled trial in rural Bangladesh. PLoS Med. 2022 Aug 8;19(8):e1004041. doi: 10.1371/journal.pmed.1004041. eCollection 2022 Aug.
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