Clinical trial NCT02441699: Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
Official title: Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diarrhea
Enteric Infection
Soil-transmitted Helminth Infection
Stunting
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Emory University
name: KIIT University, Bhubaneswar, Orissa
name: Gram Vikas, Bhubanesar, Orissa
name: Loyola Hospital, Bhubaneswar, Orissa
name: Bill and Melinda Gates Foundation
First posted: 2015-05-12
Enrollment: 2940
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rural householders living in Ganjam district, Orissa, India.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reported diarrhoea in children <5 years
timeFrame: 7-day recall, assessed 4 times during 3-month follow-up rounds
Secondary outcomes:
measure: Reported lower respiratory infection in children <5
timeFrame: 7-day recall, assessed 4 times during 3-month follow-up rounds
measure: Diarrhoea among all ages
timeFrame: 7-day recall, assessed 4 times during 3-month follow-up roundsits
measure: Lower respiratory infection among all ages
timeFrame: 7-day recall, assessed 4 times during 3-month follow-up roundsts
measure: Soil-transmitted helminth infection
timeFrame: Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
measure: Height-for-age among children < 2 years
timeFrame: Assessed approximately every 90 days for a total of four measurement over study period
measure: Weight-for-age among children <5
timeFrame: Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
measure: Biomarkers of environmental enteropathy and enteric infection
timeFrame: Assessed once during round 3 (approximately 180 to 240 days following commencement of study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London School of Hygiene & Tropical Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.