Condition category
Digestive System
Date applied
21/02/2015
Date assigned
13/03/2015
Last edited
13/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Globally, about 88% of cases of diarrheal disease is due to an unsafe water supply and lack of sufficient sanitation and hygiene. Although a number of studies have been conducted to explore the effect of water quality treatments, the majority of them were based on inadequately randomized trials, used excessive recall period or trials were not blinded. In addition, there has been debate over the difference in the effect of household-based water treatment and improved water supply or source-based water between enthusiasts and sceptics of point-of-use treatment. This study aims to investigate the effect of an improved source-based water supply on the number of children under 5 suffering from diarrheal disease, employing rigorous methodology to overcome limitations previous studies encountered. We also aim ensure key findings are used as a basis for a better approach to providing good quality water.

Who can participate?
Households with children under 5 years of age living in communities located in Krachi East and West district (Ghana).

What does the study involve?
Communities taking place in the study are randomly allocated into one of two groups, an intervention group and a control group. Water boreholes are drilled in all communities but only those allocated to the intervention group are used for the duration of the study. Assessments include cases of diarrhoea in children under five, amount of safe drinking water, whether there is an increase in awareness and practice of handwashing and how long it takes to fetch water on a daily basis.

What are the possible benefits and risks of participating?
We expect that the people living in communities in the intervention group to be less likely to contract diarrhoea, benefiting from clean water supply. Risks are not expected.

Where is the study run from?
Communities in the Krachi West and Krachi East districts, Volta Region (Ghana)

When is the study starting and how long is it expected to run for?
January 2012 to March 2015

Who is funding the study?
Korea International Cooperation Agency

Who is the main contact?
Dr Seungman Cha
jesusdongja@hanmail.net

Trial website

Contact information

Type

Public

Primary contact

Dr Seungman Cha

ORCID ID

Contact details

825 Daewangpangyo-ro
Sujeong-gu
Seongnam-si
461-833
Korea
South
01039593286
jesusdongja@hanmail.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of clean water supply by drilling boreholes on diarrhoea incidence of under-five children in Krachi East and Krachi West districts, Volta region, Ghana using cluster randomized controlled trial

Acronym

Study hypothesis

Supplying safe water will reduce the diarrhoeal incidence of children under five children in Krachi West and Krachi East district, Volta Region, Ghana

Ethics approval

Ghana Health Service Ethical Review Committee, 21/03/2014, ref: GHS-ERC: 07/01/14

Study design

Phased-in design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Diarrhoeal incidence of children under five.

Intervention

For intervention communities, boreholes were drilled and for control group, boreholes were also drilled but were utilized after conducting survey.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Diarrhoeal prevalence of children under five (in the previous two weeks)

Secondary outcome measures

1. Quantity of safe water drinking
2. Time for fetching water per day
3. Knowledge, attitude, practice of handwashing at critical times

Overall trial start date

01/01/2012

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Household with children under 5 years of age
2. Mothers or caretakers agreeing on the participation of the survey with informed consent in written form.

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

600

Participant exclusion criteria

Children whose mothers or caretakers did not agree to register, by not signing a informed consent form

Recruitment start date

03/10/2012

Recruitment end date

05/02/2014

Locations

Countries of recruitment

Gibraltar, Greece, Greenland

Trial participating centre

Korea International Cooperation Agency (KOICA)
825 Daewangpangyo-ro Sejeong-gu Seongman-si
Gyeonggi-do
461-833
Korea, South

Trial participating centre

Training,Research and Networking for Development (TREND)
PO Box CT 6135
Ghana

Sponsor information

Organisation

Korea International Cooperation Agency

Sponsor details

825 Daewangpangyo-ro
Sejeong-gu
Seongman-si
Gyeonggi-do
461-833
Korea
South
031-740-0245
webmaster@koica.go.kr

Sponsor type

Government

Website

www.koica.go.kr

Funders

Funder type

Government

Funder name

Korea International Cooperation Agency

Alternative name(s)

KOICA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes