Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
20. august 2019 opdateret af: London School of Hygiene and Tropical Medicine
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.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
2940
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, WC1E 7HT
- London School of Hygiene & Tropical Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Rural householders living in Ganjam district, Orissa, India.
Beskrivelse
Inclusion Criteria:
- Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.
Exclusion Criteria:
- None
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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.
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Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Reported diarrhoea in children <5 years
Tidsramme: 7-day recall, assessed 4 times during 3-month follow-up rounds
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7-day recall, assessed 4 times during 3-month follow-up rounds
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Reported lower respiratory infection in children <5
Tidsramme: 7-day recall, assessed 4 times during 3-month follow-up rounds
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7-day recall, assessed 4 times during 3-month follow-up rounds
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Diarrhoea among all ages
Tidsramme: 7-day recall, assessed 4 times during 3-month follow-up roundsits
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7-day recall, assessed 4 times during 3-month follow-up roundsits
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Lower respiratory infection among all ages
Tidsramme: 7-day recall, assessed 4 times during 3-month follow-up roundsts
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7-day recall, assessed 4 times during 3-month follow-up roundsts
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Soil-transmitted helminth infection
Tidsramme: Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
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Stool samples taken and assayed for ascaris, trichuris, hookworm
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Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
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Height-for-age among children < 2 years
Tidsramme: Assessed approximately every 90 days for a total of four measurement over study period
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Children height measured and HAZ scores computed
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Assessed approximately every 90 days for a total of four measurement over study period
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Weight-for-age among children <5
Tidsramme: Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
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Children weighed and WAZ scores computed
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Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
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Biomarkers of environmental enteropathy and enteric infection
Tidsramme: Assessed once during round 3 (approximately 180 to 240 days following commencement of study
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Assessed once during round 3 (approximately 180 to 240 days following commencement of study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Reese 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.
- Reese 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2015
Primær færdiggørelse (Forventet)
1. december 2019
Studieafslutning (Forventet)
1. december 2019
Datoer for studieregistrering
Først indsendt
27. april 2015
Først indsendt, der opfyldte QC-kriterier
7. maj 2015
Først opslået (Skøn)
12. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9071
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diarré
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Merck Sharp & Dohme LLCAfsluttetClostridium Difficile Associated Diarrhea (CDAD)
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Merck Sharp & Dohme LLCAfsluttetClostridium Difficile Associated Diarrhea (CDAD)
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PharmaPlanter Technologies IncIkke rekrutterer endnuIrritabel tyktarm (IBS) | Clostridioides Difficile-infektion | Irritable Towel Syndrome, Diarrhea-Predominant (IBS-D) | Gentagne Clostridioides difficile infektion (RCDI) | Fækal mikrobiota -terapi (FMT)