WASH Benefits Child Development Follow up

NCT ID: NCT04443855

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4932 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Globally, millions of children experience delays in physical health and cognitive development, due to their exposures to poverty and related issues. In low-and middle-income countries, children experience a dis-proportionally high burden of exposure to poverty and related risk factors for delayed development including of poor health and nutrition, inadequate responsive care giving, and a lack of opportunities for early learning. Water, sanitation and hygiene (WASH) interventions have the potential to positively affect the developmental trajectories of children by reducing enteric pathogen infection, improving child health, and altering parental care practices. A recent cluster-randomized controlled trial (cRCT) in Bangladesh (WASH-Benefits, or WASH-B, Clinical Trials.gov Identifier: NCT01590095), found that improvements in WASH or nutrition supported by intensive interpersonal communication, when delivered either individually or in combination, contributed to improvements in child development outcomes at 1 and 2 years of age, and mothers in all intervention groups reported lower depressive symptoms than mothers in the control households.

This follow-up study, funded by the Bill \& Melinda Gates foundation, includes assessments of the children and caregivers originally enrolled in the WASH Benefits intervention 5 years following intervention completion, when the children are 5-8 year of age. The original WASH Benefits intervention enrolled pregnant women between May 31, 2012, and July 7, 2013. The goal of this follow-up study is to examine whether the improvements in child development and maternal mental health are sustained when the children are in middle childhood. Our guiding hypothesis is that interventions that showed early impact will continue to improve child and maternal outcomes at this follow-up time period. Investigators will attempt to collect follow-up data from every household originally randomized to one of the 7 arms in the WASH Benefits trial.

Conditions

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Child Development Maternal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Water quality

90 clusters, approx. 720 newborns

Group Type ACTIVE_COMPARATOR

Water quality

Intervention Type BEHAVIORAL

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.

Sanitation

90 clusters, approx. 720 newborns

Group Type ACTIVE_COMPARATOR

Sanitation

Intervention Type BEHAVIORAL

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.

Hand washing

90 clusters, approx. 720 newborns

Group Type ACTIVE_COMPARATOR

Hand washing

Intervention Type BEHAVIORAL

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

90 clusters, approx. 720 newborns

Group Type ACTIVE_COMPARATOR

Water quality, Sanitation, Hand washing (Combined WASH)

Intervention Type 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.

Nutrition

90 clusters, approx. 720 newborns

Group Type ACTIVE_COMPARATOR

Nutrition

Intervention Type BEHAVIORAL

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+ Combined WASH

90 clusters, approx. 720 newborns

Group Type ACTIVE_COMPARATOR

Nutrition, Water quality, Sanitation, Hand washing

Intervention Type BEHAVIORAL

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

Non-intervention

180 clusters, approx. 1,440 newborns

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Water quality

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.

Intervention Type BEHAVIORAL

Sanitation

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.

Intervention Type BEHAVIORAL

Hand washing

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.

Intervention Type BEHAVIORAL

Water quality, Sanitation, Hand washing (Combined WASH)

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.

Intervention Type BEHAVIORAL

Nutrition

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.

Intervention Type BEHAVIORAL

Nutrition, Water quality, Sanitation, Hand washing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in the wash-benefits Bangladesh intervention
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahbubur Rahman, MD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Mahbubur Rahman, MD

Role: CONTACT

+880-2-9827001-10 ext. 4003

Facility Contacts

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Mahbubur Rahman, MD

Role: primary

+880-2-9827001-10 ext. 4003

Other Identifiers

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PR-19025

Identifier Type: -

Identifier Source: org_study_id

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