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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,040

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 30, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 13, 2022

Status Verified

January 1, 2022

Enrollment Period

10.6 years

First QC Date

April 30, 2012

Last Update Submit

April 12, 2022

Conditions

Keywords

Chlorine water treatmentPoint-of-use water treatmentHousehold water treatment with safe storageHand washing with soapHand hygieneLatrinesChild pottiesPoint-of-use fortificationLipid-based nutrient supplementEnvironmental enteropathyTropical enteropathyGut functionIntestinal parasitic infectionSoil transmitted helminthsIntestinal protozoansAntibody responseWaterSanitationHand washingBreast FeedingComplementary FeedingMicronutrientsMalnutritionNutrition DisordersDiarrheaChild Development

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 24monthsafter intervention. Measurement techniques follow the FANTA 2003 protocol.

    Measured 24 months after intervention

  • Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence 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-monthsafter 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 (7)

Water quality

ACTIVE COMPARATOR

90 clusters, approx. 720 newborns

Behavioral: Water quality

Sanitation

ACTIVE COMPARATOR

90 clusters, approx. 720 newborns

Behavioral: Sanitation

Hand washing

ACTIVE COMPARATOR

90 clusters, approx. 720 newborns

Behavioral: Hand washing

Combined WASH

ACTIVE COMPARATOR

90 clusters, approx. 720 newborns

Behavioral: Water quality, Sanitation, Hand washing (Combined WASH)

Nutrition

ACTIVE COMPARATOR

90 clusters, approx. 720 newborns

Behavioral: Nutrition

Nutrition + Combined WASH

ACTIVE COMPARATOR

90 clusters, approx. 720 newborns

Behavioral: Nutrition, Water quality, Sanitation, Hand washing

Non-intervention

NO INTERVENTION

180 clusters, approx. 1,440 newborns

Interventions

Water qualityBEHAVIORAL

Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children \< 36 months of age.

Water quality
SanitationBEHAVIORAL

Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly 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.

Sanitation
Hand washingBEHAVIORAL

Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.

Hand washing

Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children \< 36 months of age. Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly 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. Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.

Combined WASH
NutritionBEHAVIORAL

Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months. Promotion: Local promoters will visit study compounds at least monthly 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.

Nutrition

Each of the interventions described above for Water Quality, Sanitation \& Hand washing (Combined WASH) Plus the intervention described above for nutrition.

Nutrition + Combined WASH

Eligibility Criteria

Age1 Day - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (1) Infants (target child) will be eligible to participate in the study if they are:
  • They are in utero at the baseline survey
  • 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:
  • They are \< 36 months old at the baseline survey
  • 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:
  • They are 18 - 27 months old at the baseline survey
  • Their parents/guardians are planning to stay in the study village for the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Mahbubur Rahman

Dhaka, 1212, Bangladesh

Location

Related Publications (17)

  • Chen B, Mertens AN, Lin CH, Tan ST, Jamshed F, Figueroa D, Hemlock C, Butzin-Dozier Z, Fernald LC, Stewart CP, Hubbard AE, Rahman MZ, Ali S, Arnold BF, Dhabhar FS, Granger DA, Rahman M, Luby SP, Colford JM Jr, Lin A. Associations Between Micronutrient Status, Hormones, and Immune Status During Pregnancy and Child Growth in Rural Bangladesh: A Prospective Cohort Study. Curr Dev Nutr. 2025 Nov 8;9(12):107596. doi: 10.1016/j.cdnut.2025.107596. eCollection 2025 Dec.

  • Tofail F, Pitchik HO, Islam M, Khan R, Shoab AK, Akter F, Aktar S, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. Effects of early water, sanitation, handwashing, and nutrition interventions on child development at school age: a follow-on study of a cluster-randomized trial in rural Bangladesh. PLoS Med. 2025 Dec 16;22(12):e1004793. doi: 10.1371/journal.pmed.1004793. eCollection 2025 Dec.

  • Lin A, Mertens AN, Rahman MZ, Tan ST, Il'yasova D, Spasojevic I, Ali S, Stewart CP, Fernald LCH, Kim L, Yan L, Meyer A, Karim MR, Shahriar S, Shuman G, Arnold BF, Hubbard AE, Famida SL, Akther S, Hossen MS, Mutsuddi P, Shoab AK, Shalev I, Rahman M, Unicomb L, Heaney CD, Kariger P, Colford JM Jr, Luby SP, Granger DA. A cluster-randomized trial of water, sanitation, handwashing and nutritional interventions on stress and epigenetic programming. Nat Commun. 2024 Apr 26;15(1):3572. doi: 10.1038/s41467-024-47896-z.

  • 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.

  • Lin A, Mertens AN, Arnold BF, Tan S, Lin J, Stewart CP, Hubbard AE, Ali S, Benjamin-Chung J, Shoab AK, Rahman MZ, Famida SL, Hossen MS, Mutsuddi P, Akther S, Rahman M, Unicomb L, Naved RT, Mamun MMA, Parvin K, Dhabhar FS, Kariger P, Fernald LC, Luby SP, Colford JM Jr. Telomere length is associated with growth in children in rural Bangladesh. Elife. 2021 Sep 8;10:e60389. doi: 10.7554/eLife.60389.

  • Kwong LH, Sen D, Islam S, Shahriar S, Benjamin-Chung J, Arnold BF, Hubbard A, Parvez SM, Islam M, Unicomb L, Rahman MM, Nelson K, Colford JM Jr, Luby SP, Ercumen A. Effect of sanitation improvements on soil-transmitted helminth eggs in courtyard soil from rural Bangladesh: Evidence from a cluster-randomized controlled trial. PLoS Negl Trop Dis. 2021 Jul 28;15(7):e0008815. doi: 10.1371/journal.pntd.0008815. eCollection 2021 Jul.

  • Contreras JD, Islam M, Mertens A, Pickering AJ, Kwong LH, Arnold BF, Benjamin-Chung J, Hubbard AE, Alam M, Sen D, Islam S, Rahman M, Unicomb L, Luby SP, Colford JM, Ercumen A. Longitudinal Effects of a Sanitation Intervention on Environmental Fecal Contamination in a Cluster-Randomized Controlled Trial in Rural Bangladesh. Environ Sci Technol. 2021 Jun 15;55(12):8169-8179. doi: 10.1021/acs.est.1c01114. Epub 2021 Jun 4.

  • Parvez SM, Rahman MJ, Azad R, Rahman M, Unicomb L, Ashraf S, Mondol MH, Jahan F, Winch PJ, Luby SP. Achieving equitable uptake of handwashing and sanitation by addressing both supply and demand-based constraints: findings from a randomized controlled trial in rural Bangladesh. Int J Equity Health. 2021 Jan 6;20(1):16. doi: 10.1186/s12939-020-01353-7.

  • Ercumen A, Benjamin-Chung J, Arnold BF, Lin A, Hubbard AE, Stewart C, Rahman Z, Parvez SM, Unicomb L, Rahman M, Haque R, Colford JM Jr, Luby SP. Effects of water, sanitation, handwashing and nutritional interventions on soil-transmitted helminth infections in young children: A cluster-randomized controlled trial in rural Bangladesh. PLoS Negl Trop Dis. 2019 May 3;13(5):e0007323. doi: 10.1371/journal.pntd.0007323. eCollection 2019 May.

  • Lin A, Ali S, Arnold BF, Rahman MZ, Alauddin M, Grembi J, Mertens AN, Famida SL, Akther S, Hossen MS, Mutsuddi P, Shoab AK, Hussain Z, Rahman M, Unicomb L, Ashraf S, Naser AM, Parvez SM, Ercumen A, Benjamin-Chung J, Haque R, Ahmed T, Hossain MI, Choudhury N, Jannat K, Alauddin ST, Minchala SG, Cekovic R, Hubbard AE, Stewart CP, Dewey KG, Colford JM, Luby SP. Effects of Water, Sanitation, Handwashing, and Nutritional Interventions on Environmental Enteric Dysfunction in Young Children: A Cluster-randomized, Controlled Trial in Rural Bangladesh. Clin Infect Dis. 2020 Feb 14;70(5):738-747. doi: 10.1093/cid/ciz291.

  • 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.

  • Parvez SM, Azad R, Rahman M, Unicomb L, Ram PK, Naser AM, Stewart CP, Jannat K, Rahman MJ, Leontsini E, Winch PJ, Luby SP. Achieving optimal technology and behavioral uptake of single and combined interventions of water, sanitation hygiene and nutrition, in an efficacy trial (WASH benefits) in rural Bangladesh. Trials. 2018 Jul 6;19(1):358. doi: 10.1186/s13063-018-2710-8.

  • Rahman M, Ashraf S, Unicomb L, Mainuddin AKM, Parvez SM, Begum F, Das KK, Naser AM, Hussain F, Clasen T, Luby SP, Leontsini E, Winch PJ. WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial. Trials. 2018 Jul 6;19(1):360. doi: 10.1186/s13063-018-2708-2.

  • Lin A, Ercumen A, Benjamin-Chung J, Arnold BF, Das S, Haque R, Ashraf S, Parvez SM, Unicomb L, Rahman M, Hubbard AE, Stewart CP, Colford JM Jr, Luby SP. Effects of Water, Sanitation, Handwashing, and Nutritional Interventions on Child Enteric Protozoan Infections in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Clin Infect Dis. 2018 Oct 30;67(10):1515-1522. doi: 10.1093/cid/ciy320.

  • Tofail F, Fernald LC, Das KK, Rahman M, Ahmed T, Jannat KK, Unicomb L, Arnold BF, Ashraf S, Winch PJ, Kariger P, Stewart CP, Colford JM Jr, Luby SP. Effect of water quality, sanitation, hand washing, and nutritional interventions on child development in rural Bangladesh (WASH Benefits Bangladesh): a cluster-randomised controlled trial. Lancet Child Adolesc Health. 2018 Apr;2(4):255-268. doi: 10.1016/S2352-4642(18)30031-2.

  • Lin A, Arnold BF, Mertens AN, Lin J, Benjamin-Chung J, Ali S, Hubbard AE, Stewart CP, Shoab AK, Rahman MZ, Hossen MS, Mutsuddi P, Famida SL, Akther S, Rahman M, Unicomb L, Dhabhar FS, Fernald LCH, Colford JM Jnr, Luby SP. Effects of water, sanitation, handwashing, and nutritional interventions on telomere length among children in a cluster-randomized controlled trial in rural Bangladesh. Elife. 2017 Oct 5;6:e29365. doi: 10.7554/eLife.29365.

  • 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.

Related Links

MeSH Terms

Conditions

MalnutritionDiarrheaSprue, TropicalIntestinal Diseases, ParasiticBreast FeedingNutrition Disorders

Interventions

Water QualitySanitationHand DisinfectionNutritional Status

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesParasitic DiseasesInfectionsFeeding BehaviorBehavior

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

  • Stephen P Luby, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 13, 2022

Record last verified: 2022-01

Locations