Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
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ClinicalTrials.gov Identifier: NCT01214785 |
Recruitment Status :
Completed
First Posted : October 5, 2010
Last Update Posted : August 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diarrhoea Soil-transmitted Helminth Infection Nutritional Status | Behavioral: Provision of household latrines | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | June 30, 2017 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Sanitation 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. |
No Intervention: Control |
- Diarrhoea (<5s) [ Time Frame: 21 months ]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)
- Soil-transmitted helminth infection [ Time Frame: baseline and endline ]Prevalence of soil-transmitted helminth infection at the end of the follow-up period
- Weight-for-age (<5s) [ Time Frame: 21 months ]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 [ Time Frame: 21 months ]
- healthcare expenditure [ Time Frame: 21 months ]
- latrine coverage and use [ Time Frame: 21 months ]
- bacteriological water quality [ Time Frame: 21 months ]
- fly counts [ Time Frame: 21 months ]
- Height-for-age [ Time Frame: baseline and endline ]Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.
- Diarrhoea (all ages) [ Time Frame: 21 months ]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).

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214785
India | |
Xavier Institute of Management | |
Bhubaneswar, Orissa, India |
Principal Investigator: | Thomas Clasen, PhD | London School of Hygiene and Tropical Medicine |
Responsible Party: | Thomas Clasen, Dr, London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT01214785 |
Other Study ID Numbers: |
MR03 |
First Posted: | October 5, 2010 Key Record Dates |
Last Update Posted: | August 24, 2017 |
Last Verified: | August 2017 |
Infections Helminthiasis Diarrhea Signs and Symptoms, Digestive Parasitic Diseases |