Pakistan Flocculent Health Outcome Study

NCT ID: NCT01538953

Last Updated: 2012-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8949 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Handwashing

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

Group Type EXPERIMENTAL

handwashing

Intervention Type OTHER

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

handwashing and water treatment

Group Type EXPERIMENTAL

handwashing

Intervention Type OTHER

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

flocculent-disinfectant for water treatment

Intervention Type OTHER

participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it

Water treatment with sodium hypochlorite

Group Type EXPERIMENTAL

water treatment with sodium hypochlorite

Intervention Type OTHER

participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it

Water treatment with flocculent-disinfectant

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

Group Type EXPERIMENTAL

flocculent-disinfectant for water treatment

Intervention Type OTHER

participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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handwashing

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

Intervention Type OTHER

flocculent-disinfectant for water treatment

participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it

Intervention Type OTHER

water treatment with sodium hypochlorite

participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Oriented Preventive Education

OTHER

Sponsor Role collaborator

Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Health-Oriented Preventive Education

Karachi, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type RESULT
PMID: 16553931 (View on PubMed)

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.

Reference Type RESULT
PMID: 1955657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22986783 (View on PubMed)

Other Identifiers

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CDC3794

Identifier Type: -

Identifier Source: org_study_id

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