MalnutritionWASHB-KenyaNCT01704105
WASH Benefits Kenya
A study testing Water Quality, Sanitation and Handwashing in people with Malnutrition and Diarrhea, run by Innovations for Poverty Action at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Diarrhea, Child Development
- What is being tested?
- Water Quality, Sanitation and Handwashing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,246 participants
- Where
- 1 siteKenya
- Study dates
- Nov 2012to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The study excludes households who do not own their home to help mitigate attrition during follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Malnutrition, Diarrhea, Child Development
- Being tested
- Water Quality, Sanitation, Handwashing, Nutrition
- 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
- Medical subject headings
- Malnutrition, Diarrhea, Breast Feeding, Nutrition Disorders, Sprue, Tropical, Intestinal Diseases, Parasitic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water QualityBehavioural
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.
SanitationBehavioural
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.
HandwashingBehavioural
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.
NutritionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Water Quality | Active comparator | 100 clusters, approximately 1,000 newborns Receives: Behavioral: Water Quality |
| Sanitation | Active comparator | 100 clusters, approximately 1,000 newborns Receives: Behavioral: Sanitation |
| Handwashing | Active comparator | 100 clusters, approximately 1,000 newborns Receives: Behavioral: Handwashing |
| Combined Water, Sanitation, and Handwashing | Active comparator | 100 clusters, approximately 1,000 newborns Receives: Behavioral: Water Quality; Behavioral: Sanitation; Behavioral: Handwashing |
| Nutrition | Active comparator | 100 clusters, approximately 1,000 newborns Receives: Dietary Supplement: Nutrition |
| Nutrition + Combined Water, Sanitation, and Handwashing | Active comparator | 100 clusters, approximately 1,000 newborns Receives: Behavioral: Water Quality; Behavioral: Sanitation; Behavioral: Handwashing; Dietary Supplement: Nutrition |
| Active control arm | No intervention | 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. |
| Passive control arm | No intervention | 100 clusters, approximately 1,000 newborns. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-for-Age Z-scores
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.
Measured: Measured 24 months after intervention
Diarrhea Prevalence
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.
Measured: Measured 12 and 24 months after intervention
Secondary outcomes (4)
Length-for-Age Z-scores
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
Measured: Measured 12 months after intervention
Stunting Prevalence
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.
Measured: Measured 24 months after intervention
Enteropathy Biomarkers
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.
Measured: Measured 12- and 24 months after intervention
ASQ Child Development Scores
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).
Measured: Measured 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovations for Poverty Action
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of California, Berkeley, University of California, Davis, Tufts University, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Clair Null, Innovations for Poverty Action
- Investigators
- Clair Null, PhD, Principal investigator, Innovations for Poverty Action and Mathematica Policy ResearchChristine Stewart, PhD, Principal investigator, University of California, DavisAmy Pickering, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704105
- Sponsor's protocol ID
- IPA-2012-KE
- Other IDs
- 2011-09-3654
- Acronym
- WASHB-Kenya
- Status last verified
- Jul 2018
- First submitted
- 5 Oct 2012
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haghighi P, Wolf PL. Tropical sprue and subclinical enteropathy: a vision for the nineties. Crit Rev Clin Lab Sci. 1997;34(4):313-41. doi: 10.3109/10408369708998096.
PubMed 9288443Borghi J, Guinness L, Ouedraogo J, Curtis V. Is hygiene promotion cost-effective? A case study in Burkina Faso. Trop Med Int Health. 2002 Nov;7(11):960-9. doi: 10.1046/j.1365-3156.2002.00954.x.
PubMed 12390603Alderman H, Hoddinott J, Kinsey B. Long term consequences of early childhood malnutrition. Oxford Economic Papers-New Series 2006;58:450-474.
Checkley W, Buckley G, Gilman RH, Assis AM, Guerrant RL, Morris SS, Molbak K, Valentiner-Branth P, Lanata CF, Black RE; Childhood Malnutrition and Infection Network. Multi-country analysis of the effects of diarrhoea on childhood stunting. Int J Epidemiol. 2008 Aug;37(4):816-30. doi: 10.1093/ije/dyn099. Epub 2008 Jun 20.
PubMed 18567626Lorntz B, Soares AM, Moore SR, Pinkerton R, Gansneder B, Bovbjerg VE, Guyatt H, Lima AM, Guerrant RL. Early childhood diarrhea predicts impaired school performance. Pediatr Infect Dis J. 2006 Jun;25(6):513-20. doi: 10.1097/01.inf.0000219524.64448.90.
PubMed 16732149Niehaus MD, Moore SR, Patrick PD, Derr LL, Lorntz B, Lima AA, Guerrant RL. Early childhood diarrhea is associated with diminished cognitive function 4 to 7 years later in children in a northeast Brazilian shantytown. Am J Trop Med Hyg. 2002 May;66(5):590-3. doi: 10.4269/ajtmh.2002.66.590.
PubMed 12201596Petri WA Jr, Miller M, Binder HJ, Levine MM, Dillingham R, Guerrant RL. Enteric infections, diarrhea, and their impact on function and development. J Clin Invest. 2008 Apr;118(4):1277-90. doi: 10.1172/JCI34005.
PubMed 18382740Boissiere M, Knight JB, Sabot RH. Earnings, schooling, ability, and cognitive skills. American Economic Review 1985;75:1016-1030.
Stewart CP, Arnold CD, Williams AM, Arnold BF, Pickering AJ, Dentz H, Kiprotich M, Lin A, Null C, Colford JM Jr, Dewey KG. Social Desirability Bias in a Randomized Controlled Trial That Included Breastfeeding Promotion in Western Kenya. Curr Dev Nutr. 2024 Sep 23;9(Suppl 1):103779. doi: 10.1016/j.cdnut.2024.103779. eCollection 2025 Feb.
PubMed 40454163Pickering AJ, Njenga SM, Steinbaum L, Swarthout J, Lin A, Arnold BF, Stewart CP, Dentz HN, Mureithi M, Chieng B, Wolfe M, Mahoney R, Kihara J, Byrd K, Rao G, Meerkerk T, Cheruiyot P, Papaiakovou M, Pilotte N, Williams SA, Colford JM Jr, Null C. Effects of single and integrated water, sanitation, handwashing, and nutrition interventions on child soil-transmitted helminth and Giardia infections: A cluster-randomized controlled trial in rural Kenya. PLoS Med. 2019 Jun 26;16(6):e1002841. doi: 10.1371/journal.pmed.1002841. eCollection 2019 Jun.
PubMed 31242190Stewart CP, Dewey KG, Lin A, Pickering AJ, Byrd KA, Jannat K, Ali S, Rao G, Dentz HN, Kiprotich M, Arnold CD, Arnold BF, Allen LH, Shahab-Ferdows S, Ercumen A, Grembi JA, Naser AM, Rahman M, Unicomb L, Colford JM Jr, Luby SP, Null C. Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh. Am J Clin Nutr. 2019 Jan 1;109(1):148-164. doi: 10.1093/ajcn/nqy239.
PubMed 30624600Byrd KA, Williams TN, Lin A, Pickering AJ, Arnold BF, Arnold CD, Kiprotich M, Dentz HN, Njenga SM, Rao G, Colford JM Jr, Null C, Stewart CP. Sickle Cell and alpha+-Thalassemia Traits Influence the Association between Ferritin and Hepcidin in Rural Kenyan Children Aged 14-26 Months. J Nutr. 2018 Dec 1;148(12):1903-1910. doi: 10.1093/jn/nxy229.
PubMed 30517728Stewart CP, Kariger P, Fernald L, Pickering AJ, Arnold CD, Arnold BF, Hubbard AE, Dentz HN, Lin A, Meerkerk TJ, Milner E, Swarthout J, Colford JM Jr, Null C. Effects of water quality, sanitation, handwashing, and nutritional interventions on child development in rural Kenya (WASH Benefits Kenya): a cluster-randomised controlled trial. Lancet Child Adolesc Health. 2018 Apr;2(4):269-280. doi: 10.1016/S2352-4642(18)30025-7.
PubMed 29616236Null C, Stewart CP, Pickering AJ, Dentz HN, Arnold BF, Arnold CD, Benjamin-Chung J, Clasen T, Dewey KG, Fernald LCH, Hubbard AE, Kariger P, Lin A, Luby SP, Mertens A, Njenga SM, Nyambane G, Ram PK, Colford JM Jr. Effects of water quality, sanitation, handwashing, and nutritional interventions on diarrhoea and child growth in rural Kenya: a cluster-randomised controlled trial. Lancet Glob Health. 2018 Mar;6(3):e316-e329. doi: 10.1016/S2214-109X(18)30005-6. Epub 2018 Jan 29.
PubMed 29396219Williams AM, Stewart CP, Shahab-Ferdows S, Hampel D, Kiprotich M, Achando B, Lin A, Null CA, Allen LH, Chantry CJ. Infant Serum and Maternal Milk Vitamin B-12 Are Positively Correlated in Kenyan Infant-Mother Dyads at 1-6 Months Postpartum, Irrespective of Infant Feeding Practice. J Nutr. 2018 Jan 1;148(1):86-93. doi: 10.1093/jn/nxx009.
PubMed 29378045
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01704105
- Acronym / sponsor ID
- WASHB-Kenya / IPA-2012-KE
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,246 participants (actual)
- Lead sponsor
- Innovations for Poverty ActionUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of California, Berkeley, University of California, Davis, Tufts University, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Nov 2012 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Water Quality | Active comparator | Behavioral: Water Quality100 clusters, approximately 1,000 newborns |
| Sanitation | Active comparator | Behavioral: Sanitation100 clusters, approximately 1,000 newborns |
| Handwashing | Active comparator | Behavioral: Handwashing100 clusters, approximately 1,000 newborns |
| Combined Water, Sanitation, and Handwashing | Active comparator | Behavioral: Water Quality, Behavioral: Sanitation, Behavioral: Handwashing100 clusters, approximately 1,000 newborns |
| Nutrition | Active comparator | Dietary Supplement: Nutrition100 clusters, approximately 1,000 newborns |
| Nutrition + Combined Water, Sanitation, and Handwashing | Active comparator | Behavioral: Water Quality, Behavioral: Sanitation, Behavioral: Handwashing, Dietary Supplement: Nutrition100 clusters, approximately 1,000 newborns |
| Active control arm | No intervention | –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. |
| Passive control arm | No intervention | –100 clusters, approximately 1,000 newborns. No intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The study excludes households who do not own their home to help mitigate attrition during follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water QualityHardware: 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. | Behavioural | Combined Water, Sanitation, and Handwashing, Nutrition + Combined Water, Sanitation, and Handwashing, Water Quality |
| SanitationHardware: 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. | Behavioural | Combined Water, Sanitation, and Handwashing, Nutrition + Combined Water, Sanitation, and Handwashing, Sanitation |
| HandwashingHardware: 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. | Behavioural | Combined Water, Sanitation, and Handwashing, Handwashing, Nutrition + Combined Water, Sanitation, and Handwashing |
| NutritionSupplement: 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. | Dietary supplement | Nutrition, Nutrition + Combined Water, Sanitation, and Handwashing |
Primary outcome
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.
4 secondary outcomes
Length-for-Age Z-scores
Time frame: Measured 12 months after intervention
Stunting Prevalence
Time frame: Measured 24 months after intervention
Enteropathy Biomarkers
Time frame: Measured 12- and 24 months after intervention
ASQ Child Development Scores
Time frame: Measured 24 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Background: PubMed 9288443Haghighi P, Wolf PL. Tropical sprue and subclinical enteropathy: a vision for the nineties. Crit Rev Clin Lab Sci. 1997;34(4):313-41. doi: 10.3109/10408369708998096.
- Background: PubMed 12390603Borghi J, Guinness L, Ouedraogo J, Curtis V. Is hygiene promotion cost-effective? A case study in Burkina Faso. Trop Med Int Health. 2002 Nov;7(11):960-9. doi: 10.1046/j.1365-3156.2002.00954.x.
- BackgroundAlderman H, Hoddinott J, Kinsey B. Long term consequences of early childhood malnutrition. Oxford Economic Papers-New Series 2006;58:450-474.
- Background: PubMed 18567626Checkley W, Buckley G, Gilman RH, Assis AM, Guerrant RL, Morris SS, Molbak K, Valentiner-Branth P, Lanata CF, Black RE; Childhood Malnutrition and Infection Network. Multi-country analysis of the effects of diarrhoea on childhood stunting. Int J Epidemiol. 2008 Aug;37(4):816-30. doi: 10.1093/ije/dyn099. Epub 2008 Jun 20.
- Background: PubMed 16732149Lorntz B, Soares AM, Moore SR, Pinkerton R, Gansneder B, Bovbjerg VE, Guyatt H, Lima AM, Guerrant RL. Early childhood diarrhea predicts impaired school performance. Pediatr Infect Dis J. 2006 Jun;25(6):513-20. doi: 10.1097/01.inf.0000219524.64448.90.
- Background: PubMed 12201596Niehaus MD, Moore SR, Patrick PD, Derr LL, Lorntz B, Lima AA, Guerrant RL. Early childhood diarrhea is associated with diminished cognitive function 4 to 7 years later in children in a northeast Brazilian shantytown. Am J Trop Med Hyg. 2002 May;66(5):590-3. doi: 10.4269/ajtmh.2002.66.590.
- Background: PubMed 18382740Petri WA Jr, Miller M, Binder HJ, Levine MM, Dillingham R, Guerrant RL. Enteric infections, diarrhea, and their impact on function and development. J Clin Invest. 2008 Apr;118(4):1277-90. doi: 10.1172/JCI34005.
- BackgroundBoissiere M, Knight JB, Sabot RH. Earnings, schooling, ability, and cognitive skills. American Economic Review 1985;75:1016-1030.
- Derived from this study: PubMed 40454163Stewart CP, Arnold CD, Williams AM, Arnold BF, Pickering AJ, Dentz H, Kiprotich M, Lin A, Null C, Colford JM Jr, Dewey KG. Social Desirability Bias in a Randomized Controlled Trial That Included Breastfeeding Promotion in Western Kenya. Curr Dev Nutr. 2024 Sep 23;9(Suppl 1):103779. doi: 10.1016/j.cdnut.2024.103779. eCollection 2025 Feb.
- Derived from this study: PubMed 31242190Pickering AJ, Njenga SM, Steinbaum L, Swarthout J, Lin A, Arnold BF, Stewart CP, Dentz HN, Mureithi M, Chieng B, Wolfe M, Mahoney R, Kihara J, Byrd K, Rao G, Meerkerk T, Cheruiyot P, Papaiakovou M, Pilotte N, Williams SA, Colford JM Jr, Null C. Effects of single and integrated water, sanitation, handwashing, and nutrition interventions on child soil-transmitted helminth and Giardia infections: A cluster-randomized controlled trial in rural Kenya. PLoS Med. 2019 Jun 26;16(6):e1002841. doi: 10.1371/journal.pmed.1002841. eCollection 2019 Jun.
- Derived from this study: PubMed 30624600Stewart CP, Dewey KG, Lin A, Pickering AJ, Byrd KA, Jannat K, Ali S, Rao G, Dentz HN, Kiprotich M, Arnold CD, Arnold BF, Allen LH, Shahab-Ferdows S, Ercumen A, Grembi JA, Naser AM, Rahman M, Unicomb L, Colford JM Jr, Luby SP, Null C. Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh. Am J Clin Nutr. 2019 Jan 1;109(1):148-164. doi: 10.1093/ajcn/nqy239.
- Derived from this study: PubMed 30517728Byrd KA, Williams TN, Lin A, Pickering AJ, Arnold BF, Arnold CD, Kiprotich M, Dentz HN, Njenga SM, Rao G, Colford JM Jr, Null C, Stewart CP. Sickle Cell and alpha+-Thalassemia Traits Influence the Association between Ferritin and Hepcidin in Rural Kenyan Children Aged 14-26 Months. J Nutr. 2018 Dec 1;148(12):1903-1910. doi: 10.1093/jn/nxy229.
- Related protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clair Null, PhD principal investigator
Innovations for Poverty Action and Mathematica Policy Research
Christine Stewart, PhD principal investigator
University of California, Davis
Amy Pickering, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Quality, Sanitation and Handwashing in people with Malnutrition and Diarrhea, run by Innovations for Poverty Action at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length-for-Age Z-scores (time frame: Measured 24 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704105, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.