- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02441699
Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
20 augusti 2019 uppdaterad 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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
2940
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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London, Storbritannien, WC1E 7HT
- London School of Hygiene & Tropical Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Rural householders living in Ganjam district, Orissa, India.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Reported diarrhoea in children <5 years
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Reported lower respiratory infection in children <5
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2015
Primärt slutförande (Förväntat)
1 december 2019
Avslutad studie (Förväntat)
1 december 2019
Studieregistreringsdatum
Först inskickad
27 april 2015
Först inskickad som uppfyllde QC-kriterierna
7 maj 2015
Första postat (Uppskatta)
12 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 9071
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .