NCT01704105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

3.7 years

First QC Date

October 5, 2012

Last Update Submit

July 10, 2018

Conditions

MalnutritionDiarrheaChild Development

Keywords

Chlorine water treatmentPoint-of-use water treatmentHousehold water treatment with safe storageHandwashing with soapHand hygieneLatrinesWaterSanitationHandwashingBreast FeedingComplementary FeedingMicronutrientsMalnutritionNutrition DisordersDiarrheaChild DevelopmentChild pottiesPoint-of-use fortificationLipid-based nutrient supplementExclusive breastfeedingEnvironmental enteropathyTropical enteropathyGut functionIntestinal parasitic infectionSoil transmitted helminthsIntestinal protozoansAntibody response

Outcome Measures

Primary Outcomes (2)

  • 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 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 12 and 24 months after intervention

Secondary Outcomes (4)

  • Length-for-Age Z-scores

    Measured 12 months after intervention

  • Stunting Prevalence

    Measured 24 months after intervention

  • Enteropathy Biomarkers

    Measured 12- and 24 months after intervention

  • ASQ Child Development Scores

    Measured 24 months after intervention

Other Outcomes (3)

  • Infection with ascaris, trichuris, hookworm, and giardia

    Measured 24 months after interventions began

  • Hemoglobin concentration and anemia

    Measured 24 months after interventions began

  • Micronutrient status, including iron, vitamin A, folate, and B12

    Measured 24 months after interventions began

Study Arms (8)

Water Quality

ACTIVE COMPARATOR

100 clusters, approximately 1,000 newborns

Behavioral: Water Quality

Sanitation

ACTIVE COMPARATOR

100 clusters, approximately 1,000 newborns

Behavioral: Sanitation

Handwashing

ACTIVE COMPARATOR

100 clusters, approximately 1,000 newborns

Behavioral: Handwashing

Combined Water, Sanitation, and Handwashing

ACTIVE COMPARATOR

100 clusters, approximately 1,000 newborns

Behavioral: Water QualityBehavioral: SanitationBehavioral: Handwashing

Nutrition

ACTIVE COMPARATOR

100 clusters, approximately 1,000 newborns

Dietary Supplement: Nutrition

Nutrition + Combined Water, Sanitation, and Handwashing

ACTIVE COMPARATOR

100 clusters, approximately 1,000 newborns

Behavioral: Water QualityBehavioral: SanitationBehavioral: HandwashingDietary 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.

Interventions

Water QualityBEHAVIORAL

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.

Combined Water, Sanitation, and HandwashingNutrition + Combined Water, Sanitation, and HandwashingWater Quality
SanitationBEHAVIORAL

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.

Combined Water, Sanitation, and HandwashingNutrition + Combined Water, Sanitation, and HandwashingSanitation
HandwashingBEHAVIORAL

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.

Combined Water, Sanitation, and HandwashingHandwashingNutrition + Combined Water, Sanitation, and Handwashing
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.

NutritionNutrition + Combined Water, Sanitation, and Handwashing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action, Kenya

Kisumu, P.O Box 2663, 40100, Kenya

Location

Related Publications (17)

  • 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.

    PMID: 9288443BACKGROUND

  • Borghi 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.

    PMID: 12390603BACKGROUND

  • Alderman H, Hoddinott J, Kinsey B. Long term consequences of early childhood malnutrition. Oxford Economic Papers-New Series 2006;58:450-474.

    BACKGROUND

  • 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.

    PMID: 18567626BACKGROUND

  • Lorntz 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.

    PMID: 16732149BACKGROUND

  • Niehaus 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.

    PMID: 12201596BACKGROUND

  • Petri 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.

    PMID: 18382740BACKGROUND

  • Boissiere M, Knight JB, Sabot RH. Earnings, schooling, ability, and cognitive skills. American Economic Review 1985;75:1016-1030.

    BACKGROUND

  • 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.

    PMID: 40454163DERIVED

  • Pickering 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.

    PMID: 31242190DERIVED

  • Stewart 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.

    PMID: 30624600DERIVED

  • Byrd 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.

    PMID: 30517728DERIVED

  • Stewart 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.

    PMID: 29616236DERIVED

  • Null 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.

    PMID: 29396219DERIVED

  • Williams 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.

    PMID: 29378045DERIVED

  • Williams AM, Chantry CJ, Young SL, Achando BS, Allen LH, Arnold BF, Colford JM Jr, Dentz HN, Hampel D, Kiprotich MC, Lin A, Null CA, Nyambane GM, Shahab-Ferdows S, Stewart CP. Vitamin B-12 Concentrations in Breast Milk Are Low and Are Not Associated with Reported Household Hunger, Recent Animal-Source Food, or Vitamin B-12 Intake in Women in Rural Kenya. J Nutr. 2016 May;146(5):1125-31. doi: 10.3945/jn.115.228189. Epub 2016 Apr 13.

    PMID: 27075905DERIVED

  • Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476.

    PMID: 23996605DERIVED

Related Links

MeSH Terms

Conditions

MalnutritionDiarrheaBreast FeedingNutrition DisordersSprue, TropicalIntestinal Diseases, Parasitic

Interventions

Water QualitySanitationHand DisinfectionNutritional Status

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehaviorMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

Environmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public HealthWater PollutionCommunicable Disease ControlPublic Health PracticeHand HygieneHygieneNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Affiliate

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 11, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations

KE(1)