Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

Nutritional Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214785
• Other study ID #: MR03
• Status: Completed
• Phase: N/A
• First received: October 4, 2010
• Last updated: August 22, 2017
• Start date: September 2010
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea
• Helminthiasis
• Infection
• Nutritional Status
• Soil-transmitted Helminth Infection

Intervention

Behavioral:
• Provision 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.

Locations

Country	Name	City	State
India	Xavier Institute of Management	Bhubaneswar	Orissa

Sponsors (10)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhoea (<5s)	Longitudinal 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)	21 months
Secondary	Soil-transmitted helminth infection	Prevalence of soil-transmitted helminth infection at the end of the follow-up period	baseline and endline
Secondary	Weight-for-age (<5s)	Weight 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.	21 months
Secondary	lost days at school and work		21 months
Secondary	healthcare expenditure		21 months
Secondary	latrine coverage and use		21 months
Secondary	bacteriological water quality		21 months
Secondary	fly counts		21 months
Secondary	Height-for-age	Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.	baseline and endline
Secondary	Diarrhoea (all ages)	Longitudinal 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).	21 months