- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02441699
Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
20. august 2019 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Forventet)
2940
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia, WC1E 7HT
- London School of Hygiene & Tropical Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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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Hva måler studien?
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2015
Primær fullføring (Forventet)
1. desember 2019
Studiet fullført (Forventet)
1. desember 2019
Datoer for studieregistrering
Først innsendt
27. april 2015
Først innsendt som oppfylte QC-kriteriene
7. mai 2015
Først lagt ut (Anslag)
12. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9071
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