DiarrheaNCT02441699
Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
An observational study of Diarrhea and Enteric Infection, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diarrhea, Enteric Infection, Soil-transmitted Helminth Infection
- What is being tested?
- Improved water supply and sanitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,940 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Rural householders living in Ganjam district, Orissa, India.
Who may be able to join
- Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene & Tropical Medicine
London, WC1E 7HT
About this study
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.
Read the 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.
- Being tested
- Improved water supply and sanitation
- Medical subject headings
- Diarrhea, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved water supply and sanitationBehavioural
Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Improved water supply and sanitation | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Reported diarrhoea in children <5 years
Measured: 7-day recall, assessed 4 times during 3-month follow-up rounds
Secondary outcomes (7)
Reported lower respiratory infection in children <5
Measured: 7-day recall, assessed 4 times during 3-month follow-up rounds
Diarrhoea among all ages
Measured: 7-day recall, assessed 4 times during 3-month follow-up roundsits
Lower respiratory infection among all ages
Measured: 7-day recall, assessed 4 times during 3-month follow-up roundsts
Soil-transmitted helminth infection
Stool samples taken and assayed for ascaris, trichuris, hookworm
Measured: 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
Children height measured and HAZ scores computed
Measured: Assessed approximately every 90 days for a total of four measurement over study period
Weight-for-age among children <5
Children weighed and WAZ scores computed
Measured: 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
Measured: Assessed once during round 3 (approximately 180 to 240 days following commencement of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, KIIT University, Bhubaneswar, Orissa, Gram Vikas, Bhubanesar, Orissa, Loyola Hospital, Bhubaneswar, Orissa, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441699
- Sponsor's protocol ID
- 9071
- Status last verified
- Aug 2019
- First submitted
- 27 Apr 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinharoy SS, Reese HE, Praharaj I, Chang HH, Clasen T. Effects of a combined water and sanitation intervention on biomarkers of child environmental enteric dysfunction and associations with height-for-age z-score: A matched cohort study in rural Odisha, India. PLoS Negl Trop Dis. 2021 Mar 8;15(3):e0009198. doi: 10.1371/journal.pntd.0009198. eCollection 2021 Mar.
PubMed 33684111Reese H, Routray P, Torondel B, Sinharoy SS, Mishra S, Freeman MC, Chang HH, Clasen T. Assessing longer-term effectiveness of a combined household-level piped water and sanitation intervention on child diarrhoea, acute respiratory infection, soil-transmitted helminth infection and nutritional status: a matched cohort study in rural Odisha, India. Int J Epidemiol. 2019 Dec 1;48(6):1757-1767. doi: 10.1093/ije/dyz157.
PubMed 31363748Reese H, Routray P, Torondel B, Sclar G, Delea MG, Sinharoy SS, Zambrano L, Caruso B, Mishra SR, Chang HH, Clasen T. Design and rationale of a matched cohort study to assess the effectiveness of a combined household-level piped water and sanitation intervention in rural Odisha, India. BMJ Open. 2017 Mar 31;7(3):e012719. doi: 10.1136/bmjopen-2016-012719.
PubMed 28363920
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
- ClinicalTrials.gov ID
- NCT02441699
- Acronym / sponsor ID
- 9071
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,940 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Emory University, KIIT University, Bhubaneswar, Orissa, Gram Vikas, Bhubanesar, Orissa, Loyola Hospital, Bhubaneswar, Orissa, Bill and Melinda Gates Foundation
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: Improved water supply and sanitationRural 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rural householders living in Ganjam district, Orissa, India.
Key inclusion criteria (1 listed)
- Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved water supply and sanitationVillage-level reticulated water supply with distribution to household taps; pour-flush pit latrines. | Behavioural | Intervention group |
Primary outcome
Reported diarrhoea in children <5 years
Time frame: 7-day recall, assessed 4 times during 3-month follow-up rounds
7 secondary outcomes
Reported lower respiratory infection in children <5
Time frame: 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
Lower respiratory infection among all ages
Time frame: 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)
Height-for-age among children < 2 years
Time frame: 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
Biomarkers of environmental enteropathy and enteric infection
Time frame: Assessed once during round 3 (approximately 180 to 240 days following commencement of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Derived from this study: PubMed 33684111Sinharoy SS, Reese HE, Praharaj I, Chang HH, Clasen T. Effects of a combined water and sanitation intervention on biomarkers of child environmental enteric dysfunction and associations with height-for-age z-score: A matched cohort study in rural Odisha, India. PLoS Negl Trop Dis. 2021 Mar 8;15(3):e0009198. doi: 10.1371/journal.pntd.0009198. eCollection 2021 Mar.
- Derived from this study: PubMed 31363748Reese H, Routray P, Torondel B, Sinharoy SS, Mishra S, Freeman MC, Chang HH, Clasen T. Assessing longer-term effectiveness of a combined household-level piped water and sanitation intervention on child diarrhoea, acute respiratory infection, soil-transmitted helminth infection and nutritional status: a matched cohort study in rural Odisha, India. Int J Epidemiol. 2019 Dec 1;48(6):1757-1767. doi: 10.1093/ije/dyz157.
- Derived from this study: PubMed 28363920Reese H, Routray P, Torondel B, Sclar G, Delea MG, Sinharoy SS, Zambrano L, Caruso B, Mishra SR, Chang HH, Clasen T. Design and rationale of a matched cohort study to assess the effectiveness of a combined household-level piped water and sanitation intervention in rural Odisha, India. BMJ Open. 2017 Mar 31;7(3):e012719. doi: 10.1136/bmjopen-2016-012719.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea and Enteric Infection, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported diarrhoea in children <5 years (time frame: 7-day recall, assessed 4 times during 3-month follow-up rounds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441699, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.