DiarrheaWASHNCT02779010
Impact of Hand Washing and WASH Educational Intervention on Under-five Diarrheal Diseases
A study testing Hand washing with soap and Health education in people with Diarrhea, run by Ethiopian Institute of Water Resources.
Trial summary
The investigators evaluated the impact of water, sanitation and hygiene educational Intervention and hand washing with soap on the incidence of diarrhea among under-five children. Read more about this study
- Who is it for?
- Ages 1 month to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Hand washing with soap and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,190 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one child aged 0-59 months living in the home
- And non model health extension household.
Who cannot join
- A household was excluded if the household graduated model health extension households.
About this study
Official title: Hand Washing and WASH Educational Intervention in Reducing Incidence of Diarrhea Among Under-five Children in Eastern Ethiopia: A Community-based Cluster Randomized Controlled Trial
The investigators evaluated the impact of water, sanitation and hygiene educational Intervention and hand washing with soap on the incidence of diarrhea among under-five children.
Read the detailed description
METHODS Ethics statement The study protocols have been reviewed and approved by the Jigjiga University ethical review committee. Study consent was obtained from district administration, district health office and community leaders. Control group received books and pens to support the children's education during the study period and health education after the completion of the study. Written consent was taken from the mothers of the children. During the study no one was harmed nor died of the disease.
Study Setting The current study was conducted in the rural areas of Jigjiga district of Ethiopian-Somali Regional State (ESRS) in the Eastern Ethiopia from February 1 to July 30, 2015. The ESRS is one of the nine regional states that constitute the Federal Democratic Republic of Ethiopia. Pastoralism is a way of life whereby the livelihood of the people depends on raising livestock and living on its milk and meat (23). Nearly 90% of the population in ESRS resides in rural areas, leading either a pastoralist or agro-pastoralist lifestyle. The majority of these pastoralists are nomadic and have a pattern of seasonal movement from place to place for cattle grazing. Jigjiga district is one of the 68 districts of the region, part of Fafan zone, with a total population of 277,560 according to 2007 census conducted by the central statiscal agency of Ethiopia of whom 149,292 are men and 128,268 women. A total of 34 Kebele is found in the district of which 4 are urban and 30 are rural Kebele in the district. Finally Jigjiga district was selected for the study because of its notable of high incidence of diarrhea disease and acute watery diarrhea epidemics as reported by the Regional Health Bureau.
Sample size determination The sample was calculated by using methods published by Hayes and Bennett (24) to determine the number of communities required to detect a between-group difference in diarrhea incidence density for the under five years old. Given recent studies conducted in Eastern Ethiopia indicated disease rates for incidence of child diarrhea among home based chlorine treatment intervention and non intervention group of 4.5 episodes/100 person week observations and 10.4 episodes/100 person week observations respectively (13), 80% power, 95% confidence interval, considering a coefficient of between-cluster variation (k) of 0.62, adjusting for loss of follow up of individual households, incomplete longitudinal data and 10% drop out and design effect of three from clustering. The final sample 24 communities was calculated (12 intervention and 12 controls) with 50 children of under-five in each cluster.
Study design and procedures The study subjects was divided into 2 study groups according to clusters of community that received hygiene education and hand washing with soap interventions and those control clusters that did not receive any interventions. Only rural community of the district were selected for the study. A household was considered eligible for the study if the following criteria are met: a) at least one child aged 0-59 months living in the home and b) non model health extension household. A household was excluded if the household graduated model health extension households. The 24 communities were allocated to the intervention and control arms by having a meeting with community leaders, Kebele heads and representative from the district health office.
Intervention
The intervention of this study was an educational intervention of water and sanitation hygiene and hand washing with soap to improve water-sanitation behaviours that shown to be associated with high rates of childhood diarrhea in this region from the baseline studies:
- Water storage behavior
- Latrine availability and utilization
- Hand washing after defecation and before meal preparation and eating by using soap Mothers/caretakers in the intervention group 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.
Mothers of the control group continued their way disposal of water storage behavior, latrine sanitation and hand washing practices.
Data collection A baseline survey was conducted on mother/caretaker, child and environmental characteristics and pre-intervention diarrhea rates by using questionnaire that was translated from English to local language, Somali. The field workers also arranged neighborhood meetings to illustrate the pamphlets and show health problems resulting from hand and water contamination and to show specific instruction on how to use the intervention assigned to the cluster in every week during the study period. Each participating household received a package of health education messages and soap (white bars). The field workers encouraged mothers/care takers to wet their hands, lather them completely with soap, and rub together for 1 minute after cleaning and child who had defecated, before food preparation, before eating and before feeding children.
Outcome assessment The Primary outcome was longitudinal incidence of diarrhea. Diarrhea is defined as the passage of three or more liquid or semi-liquid stools in a 24-hour period or the passage of at least one liquid or semi-liquid stool with blood or mucus (25). The data collectors visited intervention and control households in every 2 weeks period (12 visits) at the same time to collect outcome data. At each visit, daily episodes of diarrhea over the last previous 2 weeks were recorded for each under-five children based on the report of the mother/caretaker of the child. The secondary outcome was bacteriological quality of drinking water at household level.
Data analysis All data collected was cross checked by the field supervisors at the field sites on a daily basis. Prior to data entry, base line and surveillance data forms were checked for completeness and consistence. Data was double entered on to EPI data Version 3.5.3 and statistical analysis was performed by using STATA Version 13. Intention- to- treat analysis was used to compare the incidence of diarrhea among children under-five years of age between intervention and control arms. During the six months after the intervention, the rate of diarrhea (per 100 person-weeks) in children under-five years of age was measured for the intervention communities and for the control communities. Water quality parameters were also determined and compared among the intervention and control communities.
- Conditions
- Diarrhea
- Being tested
- Hand washing with soap and Health education
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand washing with soap and Health educationBehavioural
Health education on key environmental variables and hand washing with soap
| Study group | Role | What they receive |
|---|---|---|
| Hand washing with soap | Experimental | Hand washing with soap and health education every 2 weeks for 6 months Receives: Behavioral: Hand washing with soap and Health education |
| Books and pens | No intervention | Books and pens for every 2 months for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrheal disease among under five children
Incidence of diarrheal diseases among under five children in both the intervention group and non intervention group
Measured: 6 months
Secondary outcomes (1)
Bacteriological quality of drinking water at household level measured at baseline and end line of the 6 months study. Determination of Escherichia coli counts and presence were done.
Status of the drinking water quality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethiopian Institute of Water Resources
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdiwahab Hashi, Ethiopian Institute of Water Resources
- Investigators
- Abdiwahab Hashi, MPH, Principal investigator, Addis Ababa Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779010
- Sponsor's protocol ID
- JJU-RERC 006/2015
- Acronym
- WASH
- Status last verified
- May 2016
- First submitted
- 16 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Washing and WASH Educational Intervention in Reducing Incidence of Diarrhea Among Under-five Children in Eastern Ethiopia: A Community-based Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02779010
- Acronym / sponsor ID
- WASH / JJU-RERC 006/2015
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,190 participants (actual)
- Lead sponsor
- Ethiopian Institute of Water ResourcesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluated the impact of water, sanitation and hygiene educational Intervention and hand washing with soap on the incidence of diarrhea among under-five children.
Detailed description
METHODS Ethics statement The study protocols have been reviewed and approved by the Jigjiga University ethical review committee. Study consent was obtained from district administration, district health office and community leaders. Control group received books and pens to support the children's education during the study period and health education after the completion of the study. Written consent was taken from the mothers of the children. During the study no one was harmed nor died of the disease.
Study Setting The current study was conducted in the rural areas of Jigjiga district of Ethiopian-Somali Regional State (ESRS) in the Eastern Ethiopia from February 1 to July 30, 2015. The ESRS is one of the nine regional states that constitute the Federal Democratic Republic of Ethiopia. Pastoralism is a way of life whereby the livelihood of the people depends on raising livestock and living on its milk and meat (23). Nearly 90% of the population in ESRS resides in rural areas, leading either a pastoralist or agro-pastoralist lifestyle. The majority of these pastoralists are nomadic and have a pattern of seasonal movement from place to place for cattle grazing. Jigjiga district is one of the 68 districts of the region, part of Fafan zone, with a total population of 277,560 according to 2007 census conducted by the central statiscal agency of Ethiopia of whom 149,292 are men and 128,268 women. A total of 34 Kebele is found in the district of which 4 are urban and 30 are rural Kebele in the district. Finally Jigjiga district was selected for the study because of its notable of high incidence of diarrhea disease and acute watery diarrhea epidemics as reported by the Regional Health Bureau.
Sample size determination The sample was calculated by using methods published by Hayes and Bennett (24) to determine the number of communities required to detect a between-group difference in diarrhea incidence density for the under five years old. Given recent studies conducted in Eastern Ethiopia indicated disease rates for incidence of child diarrhea among home based chlorine treatment intervention and non intervention group of 4.5 episodes/100 person week observations and 10.4 episodes/100 person week observations respectively (13), 80% power, 95% confidence interval, considering a coefficient of between-cluster variation (k) of 0.62, adjusting for loss of follow up of individual households, incomplete longitudinal data and 10% drop out and design effect of three from clustering. The final sample 24 communities was calculated (12 intervention and 12 controls) with 50 children of under-five in each cluster.
Study design and procedures The study subjects was divided into 2 study groups according to clusters of community that received hygiene education and hand washing with soap interventions and those control clusters that did not receive any interventions. Only rural community of the district were selected for the study. A household was considered eligible for the study if the following criteria are met: a) at least one child aged 0-59 months living in the home and b) non model health extension household. A household was excluded if the household graduated model health extension households. The 24 communities were allocated to the intervention and control arms by having a meeting with community leaders, Kebele heads and representative from the district health office.
Intervention
The intervention of this study was an educational intervention of water and sanitation hygiene and hand washing with soap to improve water-sanitation behaviours that shown to be associated with high rates of childhood diarrhea in this region from the baseline studies:
- Water storage behavior
- Latrine availability and utilization
- Hand washing after defecation and before meal preparation and eating by using soap Mothers/caretakers in the intervention group 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.
Mothers of the control group continued their way disposal of water storage behavior, latrine sanitation and hand washing practices.
Data collection A baseline survey was conducted on mother/caretaker, child and environmental characteristics and pre-intervention diarrhea rates by using questionnaire that was translated from English to local language, Somali. The field workers also arranged neighborhood meetings to illustrate the pamphlets and show health problems resulting from hand and water contamination and to show specific instruction on how to use the intervention assigned to the cluster in every week during the study period. Each participating household received a package of health education messages and soap (white bars). The field workers encouraged mothers/care takers to wet their hands, lather them completely with soap, and rub together for 1 minute after cleaning and child who had defecated, before food preparation, before eating and before feeding children.
Outcome assessment The Primary outcome was longitudinal incidence of diarrhea. Diarrhea is defined as the passage of three or more liquid or semi-liquid stools in a 24-hour period or the passage of at least one liquid or semi-liquid stool with blood or mucus (25). The data collectors visited intervention and control households in every 2 weeks period (12 visits) at the same time to collect outcome data. At each visit, daily episodes of diarrhea over the last previous 2 weeks were recorded for each under-five children based on the report of the mother/caretaker of the child. The secondary outcome was bacteriological quality of drinking water at household level.
Data analysis All data collected was cross checked by the field supervisors at the field sites on a daily basis. Prior to data entry, base line and surveillance data forms were checked for completeness and consistence. Data was double entered on to EPI data Version 3.5.3 and statistical analysis was performed by using STATA Version 13. Intention- to- treat analysis was used to compare the incidence of diarrhea among children under-five years of age between intervention and control arms. During the six months after the intervention, the rate of diarrhea (per 100 person-weeks) in children under-five years of age was measured for the intervention communities and for the control communities. Water quality parameters were also determined and compared among the intervention and control communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand washing with soap | Experimental | Behavioral: Hand washing with soap and Health educationHand washing with soap and health education every 2 weeks for 6 months |
| Books and pens | No intervention | –Books and pens for every 2 months for 6 months |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- At least one child aged 0-59 months living in the home
- And non model health extension household.
Key exclusion criteria (1 listed)
- A household was excluded if the household graduated model health extension households.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand washing with soap and Health educationHealth education on key environmental variables and hand washing with soap | Behavioural | Hand washing with soap |
Primary outcome
Diarrheal disease among under five children
Time frame: 6 months
Incidence of diarrheal diseases among under five children in both the intervention group and non intervention group
1 secondary outcome
Bacteriological quality of drinking water at household level measured at baseline and end line of the 6 months study. Determination of Escherichia coli counts and presence were done.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdiwahab Hashi, MPH principal investigator
Addis Ababa Univeristy
Questions about this trial
What is this clinical trial studying?
A study testing Hand washing with soap and Health education in people with Diarrhea, run by Ethiopian Institute of Water Resources.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrheal disease among under five children (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.