WASH Benefits Kenya (WASHB-Kenya)
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| ClinicalTrials.gov Identifier: NCT01704105 |
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Recruitment Status :
Completed
First Posted : October 11, 2012
Last Update Posted : July 12, 2018
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| Condition or disease | Intervention/treatment | Phase |
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| Malnutrition Diarrhea Child Development | Behavioral: Water Quality Behavioral: Sanitation Behavioral: Handwashing Dietary Supplement: Nutrition | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 8246 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | November 2012 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | July 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Water Quality
100 clusters, approximately 1,000 newborns
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Behavioral: Water Quality
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. |
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Active Comparator: Sanitation
100 clusters, approximately 1,000 newborns
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Behavioral: Sanitation
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. |
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Active Comparator: Handwashing
100 clusters, approximately 1,000 newborns
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Behavioral: Handwashing
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. |
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Active Comparator: Combined Water, Sanitation, and Handwashing
100 clusters, approximately 1,000 newborns
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Behavioral: Water Quality
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. Behavioral: Sanitation 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. Behavioral: Handwashing 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. |
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Active Comparator: Nutrition
100 clusters, approximately 1,000 newborns
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Dietary Supplement: Nutrition
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. |
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Active Comparator: Nutrition + Combined Water, Sanitation, and Handwashing
100 clusters, approximately 1,000 newborns
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Behavioral: Water Quality
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. Behavioral: Sanitation 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. Behavioral: Handwashing 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. Dietary Supplement: Nutrition 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. |
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No Intervention: Active control arm
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.
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No Intervention: Passive control arm
100 clusters, approximately 1,000 newborns. No intervention.
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- 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 24 months after intervention. Measurement techniques follow the FANTA 2003 protocol.
- 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 months after intervention.
- 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 12 months after 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 24 months after 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 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.
- 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).
- 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 form 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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:
- One or more women who self-identify as pregnant at the time of the baseline survey
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704105
| Kenya | |
| Innovations for Poverty Action, Kenya | |
| Kisumu, P.O Box 2663, Kenya, 40100 | |
| Principal Investigator: | Clair Null, PhD | Innovations for Poverty Action and Mathematica Policy Research | |
| Principal Investigator: | Christine Stewart, PhD | University of California, Davis | |
| Principal Investigator: | Amy Pickering, PhD | Tufts University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clair Null, Research Affiliate, Innovations for Poverty Action |
| ClinicalTrials.gov Identifier: | NCT01704105 |
| Other Study ID Numbers: |
IPA-2012-KE 2011-09-3654 ( Other Identifier: UC Berkeley ) |
| First Posted: | October 11, 2012 Key Record Dates |
| Last Update Posted: | July 12, 2018 |
| Last Verified: | July 2018 |
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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 |
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Malnutrition Diarrhea Signs and Symptoms, Digestive Nutrition Disorders |