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Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

Primary Purpose

Diarrhoea, Soil-transmitted Helminth Infection, Nutritional Status

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Provision of household latrines
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhoea

Eligibility Criteria

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

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

Sites / Locations

  • Xavier Institute of Management

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sanitation intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Soil-transmitted helminth infection
Prevalence of soil-transmitted helminth infection at the end of the follow-up period
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.
lost days at school and work
healthcare expenditure
latrine coverage and use
bacteriological water quality
fly counts
Height-for-age
Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.
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).

Full Information

First Posted
October 4, 2010
Last Updated
August 22, 2017
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
WaterAid, Xavier Institute of Management, Bhubaneswar, Bill and Melinda Gates Foundation, International Initiative for Impact Evaluation, Department for International Development, United Kingdom, University of California, Davis, Emory University, Asian Institute of Public Health, Kalinga Institute of Industrial Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01214785
Brief Title
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
Official Title
Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
WaterAid, Xavier Institute of Management, Bhubaneswar, Bill and Melinda Gates Foundation, International Initiative for Impact Evaluation, Department for International Development, United Kingdom, University of California, Davis, Emory University, Asian Institute of Public Health, Kalinga Institute of Industrial Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea, Soil-transmitted Helminth Infection, Nutritional Status

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sanitation intervention
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Provision of household latrines
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diarrhoea (<5s)
Description
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)
Time Frame
21 months
Secondary Outcome Measure Information:
Title
Soil-transmitted helminth infection
Description
Prevalence of soil-transmitted helminth infection at the end of the follow-up period
Time Frame
baseline and endline
Title
Weight-for-age (<5s)
Description
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.
Time Frame
21 months
Title
lost days at school and work
Time Frame
21 months
Title
healthcare expenditure
Time Frame
21 months
Title
latrine coverage and use
Time Frame
21 months
Title
bacteriological water quality
Time Frame
21 months
Title
fly counts
Time Frame
21 months
Title
Height-for-age
Description
Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.
Time Frame
baseline and endline
Title
Diarrhoea (all ages)
Description
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).
Time Frame
21 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Clasen, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xavier Institute of Management
City
Bhubaneswar
State/Province
Orissa
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
28511653
Citation
Routray P, Torondel B, Jenkins MW, Clasen T, Schmidt WP. Processes and challenges of community mobilisation for latrine promotion under Nirmal Bharat Abhiyan in rural Odisha, India. BMC Public Health. 2017 May 16;17(1):453. doi: 10.1186/s12889-017-4382-9.
Results Reference
derived
PubMed Identifier
27496512
Citation
Freeman MC, Majorin F, Boisson S, Routray P, Torondel B, Clasen T. The impact of a rural sanitation programme on safe disposal of child faeces: a cluster randomised trial in Odisha, India. Trans R Soc Trop Med Hyg. 2016 Jul;110(7):386-92. doi: 10.1093/trstmh/trw043.
Results Reference
derived
PubMed Identifier
25442689
Citation
Clasen T, Boisson S, Routray P, Torondel B, Bell M, Cumming O, Ensink J, Freeman M, Jenkins M, Odagiri M, Ray S, Sinha A, Suar M, Schmidt WP. Effectiveness of a rural sanitation programme on diarrhoea, soil-transmitted helminth infection, and child malnutrition in Odisha, India: a cluster-randomised trial. Lancet Glob Health. 2014 Nov;2(11):e645-53. doi: 10.1016/S2214-109X(14)70307-9. Epub 2014 Oct 9.
Results Reference
derived
PubMed Identifier
25084699
Citation
Boisson S, Sosai P, Ray S, Routray P, Torondel B, Schmidt WP, Bhanja B, Clasen T. Promoting latrine construction and use in rural villages practicing open defecation: process evaluation in connection with a randomised controlled trial in Orissa, India. BMC Res Notes. 2014 Aug 1;7:486. doi: 10.1186/1756-0500-7-486.
Results Reference
derived

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Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

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