A Study to Test the Impact of an Improved Chulha on Respiratory Health of Women and Children in Indian Slums
NCT ID: NCT02821650
Last Updated: 2021-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
262 participants
INTERVENTIONAL
2017-04-19
2020-03-10
Brief Summary
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Detailed Description
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The aim of the present trial is to reduce the levels of household air pollution and improve the respiratory health of women and children by using a locally designed and manufactured improved cook stove. The study design will be a 1:1 randomised controlled intervention trial.
The intervention group will receive a locally designed and manufactured improved cookstove (low-smoke chulha). The control group will continue using the traditional cookstove (chulha) or a combination of the traditional stove and the kerosene/diesel stove.
The first part of project EXHALE was based upon an iterative process of co-creation of a low-smoke chulha with local communities in order to support adaption and sustained uptake. A qualitative study was conducted to gain insight into the cooking practices and challenges faced with the traditional stoves. Workshops were conducted where people were involved in creating an ideal stove, using thermocol blocks. Feedback was continuously used to optimize the design of the cookstove. Improved cookstoves were evaluated in a qualitative study in a slum called Siddhaarthanagar colony in Peenya, Bangalore.
Block randomization will be performed to reduce bias and achieve balance in the allocation of participants to treatment arms. Block sizes vary between two, four and six households to reduce the possibility of knowing the next randomization allocation. The study will be single-blinded (data-analyst). Randomization is stratified for having a child aged 5 years or younger or not.
Data for the questionnaires and for the assessment of pneumonia will be collected using a tablet computer with a pre-formatted questionnaire sheet. All data collection and storage devices will be password protected. Only supervisors and the main researcher will have access to the data files, identifiers, and keys. An intention-to-treat analysis will be conducted in order to ensure external validity of the study and minimize bias.
Since the intervention is not a clinical intervention, and does not have adverse effect on the participants, a data monitoring committee has not been formed. However, to review and keep track of the progress of the trial, a clinical advisory committee comprising of relevant experts has been formed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention
Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi).
TEJ (Traditional stove to Efficient stove in Jhuggi)
TEJ (means 'Bright' in Hindi) is an improved cook stove, locally designed and manufactured, aimed at reducing the indoor air emissions and improving health outcomes. 'Jhuggi' is a Hindi word which stands for a 'slum dwelling'
control
control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove.
No interventions assigned to this group
Interventions
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TEJ (Traditional stove to Efficient stove in Jhuggi)
TEJ (means 'Bright' in Hindi) is an improved cook stove, locally designed and manufactured, aimed at reducing the indoor air emissions and improving health outcomes. 'Jhuggi' is a Hindi word which stands for a 'slum dwelling'
Eligibility Criteria
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Inclusion Criteria
* Both households with and without children will be included
* Women/mothers who are capable of being interviewed
* Will not migrate in the upcoming 2 months as far as the participants can predict
* Households cooking solely with traditional stove (chulha) or a combination of a traditional stove and a kerosene/diesel stove will be included
Exclusion Criteria
* Persons who are seriously ill will be excluded from the study
18 Years
FEMALE
Yes
Sponsors
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Maastricht University
OTHER
Responsible Party
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Megha Thakur
External PhD student at CAPHRI school of public health and primary care
Principal Investigators
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Constant Paul Van Schayck, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University, Caphri School of Public Health and Primary Care
Locations
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Ashrayanagar slum
Bangalore, Karnataka, India
Mathikere slum
Bangalore, , India
Muneshwaranagar slum
Bangalore, , India
Peenya slum
Bangalore, , India
Countries
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References
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Thakur M, Boudewijns EA, Babu GR, Winkens B, de Witte LP, Gruiskens J, Sushama P, Ghergu CT, van Schayck OCP. Low-smoke chulha in Indian slums: study protocol for a randomised controlled trial. BMC Public Health. 2017 May 16;17(1):454. doi: 10.1186/s12889-017-4369-6.
Related Links
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Other Identifiers
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076-00051
Identifier Type: -
Identifier Source: org_study_id
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