Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India

This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.

Study Overview

Detailed Description

We will undertake a matched-cohort study among 84 villages in Ganjam district, Orissa, India to assess the health impact of a program that provides improved water supplies and sanitation to rural villages.

Study Type

Observational

Enrollment (Anticipated)

2940

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, WC1E 7HT
        • London School of Hygiene & Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rural householders living in Ganjam district, Orissa, India.

Description

Inclusion Criteria:

  • Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group
Rural villages in which Gram Vikas has fully implemented its water supply and sanitation (Mantra) intervention. Intervention villages must: 1) be within 3 hours travel to the study office in Brahmapur, 2) have started the intervention by January 2003, and 3) have completed the intervention by January 2013.
Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.
Control group
Rural villages that have been matched with intervention villages on demographics and other criteria. The sampling frame for control villages is limited to those: 1) within 3 hours travel to the study office in Brahmapur, and 2) within Gram Panchayats which do not include an intervention village and are not adjacent to an intervention village, to minimize spillover effects. In addition, both intervention and control villages must appear in the Government of India Census in 2001.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reported diarrhoea in children <5 years
Time Frame: 7-day recall, assessed 4 times during 3-month follow-up rounds
7-day recall, assessed 4 times during 3-month follow-up rounds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported lower respiratory infection in children <5
Time Frame: 7-day recall, assessed 4 times during 3-month follow-up rounds
7-day recall, assessed 4 times during 3-month follow-up rounds
Diarrhoea among all ages
Time Frame: 7-day recall, assessed 4 times during 3-month follow-up roundsits
7-day recall, assessed 4 times during 3-month follow-up roundsits
Lower respiratory infection among all ages
Time Frame: 7-day recall, assessed 4 times during 3-month follow-up roundsts
7-day recall, assessed 4 times during 3-month follow-up roundsts
Soil-transmitted helminth infection
Time Frame: Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
Stool samples taken and assayed for ascaris, trichuris, hookworm
Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
Height-for-age among children < 2 years
Time Frame: Assessed approximately every 90 days for a total of four measurement over study period
Children height measured and HAZ scores computed
Assessed approximately every 90 days for a total of four measurement over study period
Weight-for-age among children <5
Time Frame: Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
Children weighed and WAZ scores computed
Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
Biomarkers of environmental enteropathy and enteric infection
Time Frame: Assessed once during round 3 (approximately 180 to 240 days following commencement of study
Assessed once during round 3 (approximately 180 to 240 days following commencement of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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