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Pakistan Flocculent Health Outcome Study

Primary Purpose

Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
handwashing
flocculent-disinfectant for water treatment
water treatment with sodium hypochlorite
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring diarrhea, handwashing, point-of-use water treatment, diarrhea longitudinal prevalence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • households in study neighborhoods
  • contain a child < 5 years old
  • have access to water for handwashing

Exclusion Criteria:

  • participated in handwashing or drinking water treatment programs with HOPE previously

Sites / Locations

  • Health-Oriented Preventive Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Handwashing

handwashing and water treatment

Water treatment with sodium hypochlorite

Water treatment with flocculent-disinfectant

Control

Arm Description

participants received weekly, in-home handwashing promotion and soap as needed

participants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water

Outcomes

Primary Outcome Measures

diarrhea longitudinal prevalence

Secondary Outcome Measures

Full Information

First Posted
February 21, 2012
Last Updated
February 24, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
Health Oriented Preventive Education, Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT01538953
Brief Title
Pakistan Flocculent Health Outcome Study
Official Title
Pakistan Flocculent Health Outcome Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Health Oriented Preventive Education, Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. The households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
diarrhea, handwashing, point-of-use water treatment, diarrhea longitudinal prevalence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8949 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handwashing
Arm Type
Experimental
Arm Description
participants received weekly, in-home handwashing promotion and soap as needed
Arm Title
handwashing and water treatment
Arm Type
Experimental
Arm Title
Water treatment with sodium hypochlorite
Arm Type
Experimental
Arm Title
Water treatment with flocculent-disinfectant
Arm Type
Experimental
Arm Description
participants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
handwashing
Intervention Description
participants received weekly in-home handwashing promotion and soap as needed
Intervention Type
Other
Intervention Name(s)
flocculent-disinfectant for water treatment
Intervention Description
participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it
Intervention Type
Other
Intervention Name(s)
water treatment with sodium hypochlorite
Intervention Description
participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it
Primary Outcome Measure Information:
Title
diarrhea longitudinal prevalence

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: households in study neighborhoods contain a child < 5 years old have access to water for handwashing Exclusion Criteria: participated in handwashing or drinking water treatment programs with HOPE previously
Facility Information:
Facility Name
Health-Oriented Preventive Education
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
16553931
Citation
Luby SP, Agboatwalla M, Painter J, Altaf A, Billhimer W, Keswick B, Hoekstra RM. Combining drinking water treatment and hand washing for diarrhoea prevention, a cluster randomised controlled trial. Trop Med Int Health. 2006 Apr;11(4):479-89. doi: 10.1111/j.1365-3156.2006.01592.x.
Results Reference
result
PubMed Identifier
1955657
Citation
Boudier E, Zurlinden B, Cour A, Rognon M, Devalland-Monnin C, Nirhy-Lanto A, el Khadissi H. [Antenatal diagnosis of achondrogenesis. Two successive cases in the same family]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):623-6. French.
Results Reference
result
PubMed Identifier
22986783
Citation
Bowen A, Agboatwalla M, Luby S, Tobery T, Ayers T, Hoekstra RM. Association between intensive handwashing promotion and child development in Karachi, Pakistan: a cluster randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Nov;166(11):1037-44. doi: 10.1001/archpediatrics.2012.1181.
Results Reference
derived

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Pakistan Flocculent Health Outcome Study

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