An interventional study of WASH Education Intervention in Diarrhea, Stunting and Children Under 5 Years, sponsored by Bule Hora University. Completed at 1 site in Ethiopia. Open to participants aged 6 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Bule Hora University · Not applicable, Interventional, and Prevention
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.
hern Ethiopia. Introduction The global burden of childhood malnutrition and diarrhea remains life-threatening, yet these conditions are preventable1,2. Factors contributing to morbidity, mortality, and impaired growth in children under five are particularly high in low- and middle-income countries3. Diarrhea is the second leading cause of child morbidity and mortality worldwide and is responsible for more than 90% of deaths in children under 5 years of age in low and middle-income countries4.
Childhood diarrhea stems from interconnected environmental, host, and socioeconomic determinants where contaminated water and inadequate sanitation perpetuate fecal-oral transmission while nutritional deficiencies including nonexclusive breastfeeding, zinc deficiency, and malnutrition compromise intestinal immunity5. Inadequate water quality, open defecation, poor waste disposal, and insufficient hand hygiene expose children to bacteria, viruses, and parasites. These repeated infections cause acute episodes of diarrhea while simultaneously inducing chronic inflammation of the intestinal mucosa. Persistent intestinal injury disrupts the epithelial barrier, allowing microbial products to translocate into the bloodstream and trigger systemic inflammation6.
As intestinal permeability increases, nutrient digestion and absorption become impaired. Chronic inflammation reduces the absorptive surface area of intestinal villi and increases energy expenditure for immune responses. Consequently, children experience mal-absorption of essential nutrients, micronutrient deficiencies, impaired immune function, and poor physical growth7. Even in the absence of overt diarrhea, chronic exposure to fecal pathogens leads to Environmental Enteric Dysfunction (EED). EED is a subclinical disorder marked by increased intestinal permeability ("leaky gut") and chronic inflammation. This silent pathway continuously impairs nutrient absorption, establishing a direct link between a dirty environment and stunting without presenting visible symptoms of illness8.
Despite a global decline in stunting rates in recent time, Ethiopia continues to report a high prevalence, with national figures revealed that around 39%, and even higher rates in rural, drought-prone districts such as pastoralist communities with poor water supply, sanitation and hygiene (WASH) conditions9. Water supply, sanitation, and hygiene interventions are among the most effective measures to protect against diarrhea and stunting10. Behaviors that encourage human contact with fecal matter include: improper disposal of feces; children defecating on the floor; rags being used to cleanse the child open defecation; and lack of hand washing open defecation, handling feces (including children's feces) or cleansing the child's perineum and before handling food by caregivers and children11. WASH interventions may be effectively promoted using culture- and context-specific behavior change strategies.
There are no "silver bullets" that apply to all settings equally, and each setting requires a unique intervention approach when implementing WASH education packages12. Noticeably, in agro-pastoral and pastoralist communities in southern Ethiopia, infants and young children regularly contact with livestock and their feces, and this poses a constant health risk. In West Guji zone, the prevalence of diarrhea among children less than two years of age was found to be as high as 36.5%, while maternal educational status, waste disposal method are major factors significantly associated with childhood diarrhea in this setting13. Evidence-based and context-specific behavioral interventions that can impact community-level knowledge, perceptions, and practices are required to effectively implement the WASH components.
Therefore, this cluster-randomized controlled trial aims to evaluate the impact of a comprehensive, behavioral change-focused WASH education intervention on the incidence of diarrhea and stunting among children under five, thereby providing crucial evidence on the efficacy of such targeted approaches in high-risk agro-pastoral and pastoralist communities.
Method and Materials Study area and period The study was conducted in Bule Hora Woreda, West Guji zone, Southern Ethiopia from November 1, 2024 - April 30, 2025. Bule Hora Woreda is one of the 10 Woredas found in west Guji zone, Oromia regional state of Ethiopia. Annual rainfall of the area ranges between 801mm to 1000mm which is high monthly (i.e. May, Jun July, August and September) and is followed by long dry season (November, December, January, February and sometimes to March and May13. The area is a rapidly developing area characterized by a mix of agricultural and urban livelihoods, while livestock production is one of the economic activities in Bule Hora Woreda. The population of the area was estimated to be over 393,000 as of 2022, with approximately 9,990 births in the past year14.
Study design A cluster randomized controlled trial was used to determine the effect of WASH education intervention on incidence diarrhea and childhood stunting among children less than five years old in Bule Hora Woreda, West Guji zone Southern Ethiopia.
Sample size determination Sample size calculation was based on the primary outcome by using the method published by Hayes and Bennett16, and thus by taking 35% reduction in incidence of diarrhea from a recent study conducted in Eastern Ethiopia17. Using this incidence, along with 80% power and 95% confidence interval (α = 0.05), and considering a Mancl DeRouen correction, the final sample of 26 clusters (13 for the intervention group and 13 for the control group) was randomly selected and included in the study.
Assumptions:
Figure 1 CONSORT flow diagram. Intervention A health education on key hygiene and environmental sanitation components of Ethiopian health extension program20, and demonstration of hand washing with soap were given to all of the intervention clusters by graduate class environmental health science students of Bule Hora University, during their attachment at the study site and health extension workers (field workers) who have taken training for 5 days.
Primary care takers of the children in the households were instructed to keep their water storage container clean and covered, to have a latrine and utilize properly, and to wash their hands and children's hands ideally with soap after defecation, before meal preparation and eating. Intervention happened every 2 weeks in a period of 6 months follow up. All interventions were delivered as planned. All households in the intervention clusters received a package of health education messages (Table 1) bi-monthly for 6 months. Each intervention took up to 3-hour time from 8:30 am to 11:30 am local time since most village residents were available in the morning time. The field workers demonstrated by face to face approach how to wash their hands with soap and rub together for 1 min. Moreover, field workers was encourage the intervention group by promoting of using latrines for defecation, removal of human and animal waste from the household area, and safe disposal of children's faeces, and household water treatment and safe storage practices to prevent diseases. Primary caretakers of the control group continued their usual way of hand washing practices, disposal of water storage behaviour and latrine sanitation and did not receive any intervention.
Data collection and Outcome assessment A baseline survey of socio-demographic factors, prevalence of childhood stunting, diarrhea, and WASH related factors was conducted on primary care takers, children and household by using face-to-face- interview questionnaire after enrolment.
Ten data collectors (field workers) and two supervisors were visited intervention and control households for a baseline and end line assessment. The primary outcome was incidence of diarrhea at every 2 weeks period and along with secondary outcome of childhood stunting; that was measured by mean height for age Z score (HFA z-score) to detect the improvement in child growth. Anthropometric measurement (height/length of the children) was collected using a measuring board with a headboard and sliding foot piece for length and a Stadio meter to measure height, following the procedure stipulated by the World Health Organization/ United Nations Children's Fund21,22.
Moreover, 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.
Operational definitions
Data processing and analysis Prior to data entry, base line and follow up visit of data forms was checked by the field supervisors for completeness and consistence. Data was double entered on to Epi-Data Version 4.2 and statistical analysis was performed by using SPSS version 25. Intention-to-treat analysis was used to compare the incidence of diarrhea among under-five children between intervention and control groups.
The baseline data was analysed and compared among the intervention and control group. The rate of diarrhea (per 100 person-weeks) in children under-five years of age was measured for the intervention and control groups. Generalized estimating equation with log link Poisson distribution family was used to compute adjusted incidence rate ratio and the corresponding 95% confidence interval of the dependent variable (longitudinal incidence of diarrhea) and covariates. Potential confounding variables (child age, child sex, and the number of under-five children, mother age and sex, type of water source, point-use water treatment and category of sanitation) are adjusted by including them as covariates in the marginal mean model. For the prevalence of stunting, Emergency Nutrition Assessment (ENA) for Standardizing Monitoring and Assessment of Relief and Transition 2011 software was used to convert raw anthropometric data into Z-scores, and compared among the intervention and control groups.
Data Quality assurances The data quality was assured by pre-testing 5% of the baseline data collection tool before the actual survey in Dugda Dawa Woreda. The data was collected by trained enumerators who spoke the local dialect. To ensure validity and reliability, the field teams was verify the proper functioning and calibration of the measurement instruments before the commencement of fieldwork and on a daily basis before starting their activities. Supervisors checked the proper implementation of the education sessions and data collection. Moreover, on spot checks was also incorporated in the process that including: minimizing clothing on the child, ensuring the scale is not over-heated in the sun and is placed on an even surface, and calibration checks conducted for the scale after each household.
Ethical statement Ethical clearance was obtained from Bule Hora University (Ref.No: BHU/IOH/IRERC/017/25). Verbal informed consent was obtained from all participating households after explaining the study purpose, procedures, risks, and benefits. For community-level agreement, verbal consent was also obtained from Woreda administration and community leaders. Participants were informed of their right to withdraw at any time without penalty.
865 studies on the registry are indexed under Diarrhea; 77 are open to participants now.
This study's enrollment of 287 is above the median of 138 across 721 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Bule Hora University is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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.
Health education on key hygiene and environmental sanitation components of the Ethiopian Health Extension Program, plus handwashing-with-soap for demonstration.
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.
Time frame: 6 months
The effect of WASH education intervention on childhood stunting among under-five children in Bule hora wereda, Southern Ethiopia
The secondary outcome of childhood stunting was measured by mean height for age Z score (HFA z-score) to detect the improvement in child growth. Anthropometric measurement (height/length of the children) was collected using a measuring board with a headboard and sliding foot piece for length and a Stadio meter to measure height, following the procedure stipulated by the World Health Organization/ United Nations Children's Fund.
Time frame: 6 months
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Plan to share: No — for privacy of the data of study participants
Ran from Nov 2024 to primary completion in Apr 2025, 5 months.
Of 125 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 5 months is below that.
Counting every sponsor, half of 156 studies reached it within 19 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bule Hora University