AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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:

  1. Water storage behavior
  2. Latrine availability and utilization
  3. 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 groups in NCT02779010
Study groupRoleWhat they receive
Hand washing with soapExperimentalHand washing with soap and health education every 2 weeks for 6 months
Receives: Behavioral: Hand washing with soap and Health education
Books and pensNo interventionBooks 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.

  1. 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)
  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.

  1. First posted20 May 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in