NCT02779010

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

May 16, 2016

Last Update Submit

May 18, 2016

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Diarrheal disease among under five children

    Incidence of diarrheal diseases among under five children in both the intervention group and non intervention group

    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.

    6 months

Study Arms (2)

Hand washing with soap

EXPERIMENTAL

Hand washing with soap and health education every 2 weeks for 6 months

Behavioral: Hand washing with soap and Health education

Books and pens

NO INTERVENTION

Books and pens for every 2 months for 6 months

Interventions

Hand washing with soap and Health educationBEHAVIORAL

Health education on key environmental variables and hand washing with soap

Hand washing with soap

Eligibility Criteria

Age1 Month - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At least one child aged 0-59 months living in the home
  • And non model health extension household.

You may not qualify if:

  • A household was excluded if the household graduated model health extension households.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diarrhea

Interventions

Hand DisinfectionSoaps

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public HealthDetergentsSurface-Active AgentsSpecialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and Agriculture

Study Officials

  • Abdiwahab Hashi, MPH

    Addis Ababa Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Abdiwahab Hashi

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 20, 2016

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 20, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share