Clinical trial NCT01704105: WASH Benefits Kenya
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Diarrhea
Child Development
Keywords: Chlorine water treatment
Point-of-use water treatment
Household water treatment with safe storage
Handwashing with soap
Hand hygiene
Latrines
Water
Sanitation
Handwashing
Breast Feeding
Complementary Feeding
Micronutrients
Malnutrition
Nutrition Disorders
Diarrhea
Child Development
Child potties
Point-of-use fortification
Lipid-based nutrient supplement
Exclusive breastfeeding
Environmental enteropathy
Tropical enteropathy
Gut function
Intestinal parasitic infection
Soil transmitted helminths
Intestinal protozoans
Antibody response
Lead sponsor: Innovations for Poverty Action
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: University of California, Berkeley
name: University of California, Davis
name: Tufts University
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2012-10-11
Enrollment: 8246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Study Population Description:

The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following criteria:

* Located in a rural area (defined as villages with \<25% residents living in rental houses, \<2 gas/petrol stations and \<10 shops)
* Not enrolled in ongoing WASH or nutrition programs
* No chlorine dispensers at water sources installed by programs separate from the present study
* Majority (\>80%) of households do not have access to piped water into the home
* At least six eligible pregnant women in the cluster at baseline.

From enrolled communities, household compounds will be enrolled if they meet the following criteria.

Inclusion Criteria:

1. One or more women who self-identify as pregnant at the time of the baseline survey
2. The woman plans to stay in the community for the next 12 months.

Exclusion Criteria:

(1) The study excludes households who do not own their home to help mitigate attrition during follow-up.

Primary outcomes:
measure: Length-for-Age Z-scores
timeFrame: Measured 24 months after intervention
measure: 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: Kisumu
country: Kenya
facility: Innovations for Poverty Action, Kenya
state: P.O Box 2663
Study officials:
affiliation: Innovations for Poverty Action and Mathematica Policy Research
name: Clair Null, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Christine Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University
name: Amy Pickering, PhD
role: PRINCIPAL_INVESTIGATOR
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