NCT04443855

Brief Summary

The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. This study is a follow-up assessment of the children and mothers enrolled in the WASH-Benefits Bangladesh study.

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
4,932

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration 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

Study Start

First participant enrolled

September 24, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 31, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

April 30, 2020

Last Update Submit

March 29, 2022

Conditions

Child DevelopmentMaternal Depression

Keywords

Child DevelopmentWASHNutrition

Outcome Measures

Primary Outcomes (5)

  • Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)

    The WPPSI-IV assessment measures cognitive development and general intellectual abilities in children 2 years 6 months to 7 years 7 months of age (2:6-7:7), and includes assessments of both performance and verbal skills.

    5 years after intervention completion

  • Executive Functioning

    This executive functioning assessment consists of three sub-scales to assess executive functioning in children including verbal memory, visual and non-verbal memory, and memory capacity.

    5 years after intervention completion

  • Child Socioemotional Development

    Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.

    5 years after intervention completion

  • Fine Motor Development

    Manual Dexterity component of Movement Assessment Battery for Children-2 (MABC-2) is a direct assessment tool used to measure fine motor skills in children 3 to 17 years of age.

    5 years after intervention completion

  • Academic achievement

    The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.

    5 years after intervention completion

Secondary Outcomes (5)

  • Maternal Mental Health

    5 years after intervention completion

  • Home environment

    5 years after intervention completion

  • School attendance

    5 years after intervention completion

  • Height-for-Age Z-scores

    5 years after intervention completion

  • Weight-for-Height Z-scores

    5 years after intervention completion

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
Water quality, Sanitation, Hand washing (Combined WASH)BEHAVIORAL

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 drinking water for children \< 36 months. 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, 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 as 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
Nutrition, Water quality, Sanitation, Hand washingBEHAVIORAL

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

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in the wash-benefits Bangladesh intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41401135DERIVED

MeSH Terms

Interventions

Water QualitySanitationHand DisinfectionNutritional Status

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

  • Mahbubur Rahman, MD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahbubur Rahman, MD

CONTACT

+880-2-9827001-10mahbubr@icddrb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The outcome assessment team is separate from the implementation team, however due to the nature of the interventions there may be intervention contents visible during the assessment. Data analysis will be masked to randomization status of clusters.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

June 23, 2020

Study Start

September 24, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 31, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

We will follow as per icddr,b data sharing policy

Locations

BA(1)