NCT07867860

Brief Summary

Background: Childhood malnutrition and diarrhea remains life-threatening, yet these conditions are preventable. Water, Sanitation, and Hygiene (WASH) interventions are among the most effective measures against diarrhea and stunting. Objective: To evaluate the effect of WASH education intervention on incidence of diarrhea and childhood stunting among under-five children in Southern Ethiopia. Methods: A Community based cluster randomized controlled trial was conducted in Bule Hora Woreda, West Guji Zone, Southern Ethiopia from November 1, 2024 - April 30, 2025. A total sample of 26 clusters (13 intervention groups and 13 control groups) were randomly selected and assigned to the intervention and control groups. Diarrhea incidence was measured through caregiver reporting of diarrheal episodes over 2 weeks for 6 month. Stunting was assessed using standardized anthropometry and calculated height-for-age Z-scores based on WHO growth standards. Generalized estimating equation with log link Poisson distribution family was used to assess the effect of intervention after adjusting for potential confounders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 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

Study Start

First participant enrolled

November 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

6 months

First QC Date

September 12, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

WASH Interventionincidence of diarrheaStuntingCluster randomized trialEthiopia

Outcome Measures

Primary Outcomes (1)

  • The effect of WASH education intervention on incidence of diarrhea among under-five children in Bule hora wereda, Southern Ethiopia

    The primary outcome was incidence of diarrhea at every 2 weeks period. Primary care takers were instructed to follow the child and report incidence of diarrhea in the previous two weeks. One health extension workers from each cluster was recruited and trained to collect information on the longitudinal incidence of diarrhea. These health extension workers visited each enrolled household every 2 weeks for 6 months after baseline. The bi-monthly report included information on any episodes of diarrhea for each under five child of the household.

    6 months

Secondary Outcomes (1)

  • The effect of WASH education intervention on childhood stunting among under-five children in Bule hora wereda, Southern Ethiopia

    6 months

Study Arms (2)

13 clusters in Berdaye district

EXPERIMENTAL

From 6 districts that originally organized by the Bule Hora woreda health office for the ease of health service program implementation, 2 districts were randomly selected. Accordingly, Garba district containing 10 kebeles ((54 sub-kebeles)), which is found at the north direction from the Bule Hora town, and the Berdaye district containing 9 kebeles (47 sub-kebeles) that found at the southern direction from the Bule Hora town was selected to include in the study. Besides, from each of the north and south districts 3 kebeles (that accounts 30% of the total kebeles in each cluster) was randomly selected. The selected kebele was further divided in to sub-kebelles (neighbourhood villages). Finally, 26 Sub-kebeles (Clusters), 13 from Gerba district in the north direction and 13 from Berdaye district in the south direction were selected randomly and assigned to the intervention and control group respectively.

Other: WASH Education Intervention

Control Arm: 13 clusters in Gerba district

NO INTERVENTION

From 6 districts that originally organized by the Bule Hora woreda health office for the ease of health service program implementation, 2 districts were randomly selected. Accordingly, Garba district containing 10 kebeles ((54 sub-kebeles)), which is found at the north direction from the Bule Hora town, and the Berdaye district containing 9 kebeles (47 sub-kebeles) that found at the southern direction from the Bule Hora town was selected to include in the study. Besides, from each of the north and south districts 3 kebeles (that accounts 30% of the total kebeles in each cluster) was randomly selected. The selected kebele was further divided in to sub-kebelles (neighbourhood villages). Finally, 26 Sub-kebeles (Clusters), 13 from Gerba district in the north direction and 13 from Berdaye district in the south direction were selected randomly and assigned to the intervention and control group respectively.

Interventions

Health education on key hygiene and environmental sanitation components of the Ethiopian Health Extension Program, plus handwashing-with-soap for demonstration.

13 clusters in Berdaye district

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
* A household that have at least one child aged 6-59 months living in the home * Not a model household

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Bule Hora University

Addis Ababa, Oromiya, 144, Ethiopia

Location

Related Publications (1)

  • 1. Merid MW, Alem AZ, Chilot D, Belay DG. Impact of access to improved water and sanitation on diarrhea reduction among rural under-five children in low and middle-income countries: a propensity score matched analysis. Trop Med Health [Internet]. 2023;51:36. Available from: https://doi.org/10.1186/s41182-023-00525-92. Dhital SR, Chojenta C, Loxton D, Asia E. Effects of mothers' water, sanitation and hygiene habits on diarrhoea and malnutrition among children under 5 years in Nepal. BMJ Public Heal. 2025;3(e001815). 3. Auma B, Id MM, Ojuka E, Kigongo E, Tumwesigye R, Id WA, et al. Prevalence of diarrhea and water sanitation and hygiene (WASH) associated factors among children under five years in Lira City Northern Uganda: Community based study. PLoS One [Internet]. 2024;425:1-14. Available from: http://dx.doi.org/10.1371/journal.pone.03050544. World Health Organization (WHO). Preventing diarrhoea through better water, sanitation and hygiene: exposures and impacts in low- and middle-income countries. 2014. 5. Zhu H, Xu F, Zhao W, Wang H, Wang H. The global burden of childhood diarrhea and its epidemiological characteristics from 1990 to 2021. Front Pediatr [Internet]. 2025;13(1656234):1-13. Available from: doi: 10.3389/fped.2025.16562346. Ri E, Je E, Arikpo D, Mm M, Ja C. Hand washing promotion for preventing diarrhoea (Review). Cochrane Database Syst Rev. 2015;(9). 7. UNICEF. Integrating water, sanitation and hygiene interventions across sectors to impact child health outcomes. In: Baby WASH Programming. 2020. 8. Ademas A, Adane M, Keleb A, Berihun G, Tesfaw G. Water, sanitation, and hygiene as a priority intervention for stunting in under-five children in northwest Ethiopia: a community-based cross-sectional study. Ital J Pediatr. 2021;47(174):1-11. 9. GBD 2019 Ethiopia Subnational-Level Disease Burden Initiative Collaborators. Progress in health among regions of Ethiopia, 1990-2019: a subnational country analysis for the Global Burden of Disease Study 2019

    BACKGROUND

MeSH Terms

Conditions

DiarrheaGrowth Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
From 6 districts that originally organized by the Bule Hora woreda health office for the ease of health service program implementation, 2 districts were randomly selected. Accordingly, Garba district containing 10 kebeles ((54 sub-kebeles)), which is found at the north direction from the Bule Hora town, and the Berdaye district containing 9 kebeles (47 sub-kebeles) that found at the southern direction from the Bule Hora town was selected to include in the study. Besides, from each of the north and south districts 3 kebeles (that accounts 30% of the total kebeles in each cluster) was randomly selected. The selected kebele was further divided in to sub-kebelles (neighbourhood villages). Finally, 26 Sub-kebeles (Clusters), 13 from Gerba district in the north direction and 13 from Berdaye district in the south direction were selected randomly and assigned to the intervention and control group respectively (Figure 1). Data collectors and outcome assessors were blinded to group allocation. P
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

September 12, 2026

First Posted

October 9, 2026

Study Start

November 1, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

for privacy of the data of study participants

Locations