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Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01214785
Enrollment
100
Registered
2010-10-05
Start date
2010-09-30
Completion date
2017-06-30
Last updated
2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhoea, Nutritional Status, Soil-transmitted Helminth Infection

Brief summary

The study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.

Interventions

BEHAVIORALProvision of household latrines

WaterAid and local NGO partners mobilize householders in target villages to construct and use latrines in accordance with the Government of India's Total Sanitation Campaign.

Sponsors

WaterAid
CollaboratorOTHER
Xavier Institute of Management, Bhubaneswar
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
International Initiative for Impact Evaluation
CollaboratorOTHER
Department for International Development, United Kingdom
CollaboratorOTHER_GOV
University of California, Davis
CollaboratorOTHER
Emory University
CollaboratorOTHER
Asian Institute of Public Health
CollaboratorOTHER
Kalinga Institute of Industrial Technology
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

Village level: * Little existing sanitation coverage (\<10%) * WaterAid and implementing partners expects normal scale up * Stable and reasonably acceptable water supply * No other WASH interventions planned or anticipated in next 30 months * Reasonable year-round access by road to permit household visits by surveillance staff Household level: * Presence of a child\<4 or a pregnant woman * Consent to participate * Reside permanently in the village

Design outcomes

Primary

MeasureTime frameDescription
Diarrhoea (<5s)21 monthsLongitudinal prevalence of diarrhoea (7-day period prevalence) measured repeatedly every 3 months over a 21-month follow-up period. Diarrhoea is defined according to the WHO definition (three of more stools passed in 24 hrs)

Secondary

MeasureTime frameDescription
bacteriological water quality21 months
fly counts21 months
Height-for-agebaseline and endlineRecumbent length measured for children \<2 at baseline and endline following standardised procedures for anthropometric assessment.
Soil-transmitted helminth infectionbaseline and endlinePrevalence of soil-transmitted helminth infection at the end of the follow-up period
latrine coverage and use21 months
lost days at school and work21 months
healthcare expenditure21 months
Diarrhoea (all ages)21 monthsLongitudinal prevalence of diarrhoea (7-day period prevalence) measured repeatedly every 3 months over a 21-month follow-up period. Diarrhoea is defined according to the WHO definition (passage of three or more loose stools in 24 hrs).
Weight-for-age (<5s)21 monthsWeight of children \<5 is recorded at each diarrhoea surveillance visit (every 3 months over the 21-month follow-up). Weight-for-age Z (WAZ) scores are calculated using the WHO growth standards. WAZ is used a proxy indicator of recent diarrhoea.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026