- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821650
A Study to Test the Impact of an Improved Chulha on Respiratory Health of Women and Children in Indian Slums
Low-smoke Chulha in Indian Slums
Study Overview
Status
Intervention / Treatment
Detailed Description
Noting the significant health impact of the use of solid fuels and traditional cooking systems on (public) health indicators, it is imperative to find clean cooking solutions for urban slum dwelling communities. While several efforts have been made to reduce indoor air pollution in India, most efforts focused on "enhancing stove energy efficiency, and not reducing emissions." Also, use of a strict top-down approach in the community was responsible for many unsuccessful projects. The current project is based on principles of co-creation, involving the local community in designing and producing clean cook stoves; a more scalable and sustainable solution than fully subsidized efforts.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bangalore, India
- Mathikere slum
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Bangalore, India
- Muneshwaranagar slum
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Bangalore, India
- Peenya slum
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Karnataka
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Bangalore, Karnataka, India, 560058
- Ashrayanagar slum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Woman ≥18 years who cooked more than 50% of the meals during the past 30 days (primary cook) and one child per household (0-5 years) will be included
- 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:
- Households with a cooking area outside the house will be excluded
- Persons who are seriously ill will be excluded from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi).
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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'
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No Intervention: control
control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function
Time Frame: 1 year
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Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook
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1 year
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Pneumonia
Time Frame: 1 year
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Measure incidence of pneumonia for children ≤5 years.
The incidence of pneumonia for children ≤5 years will be determined according to the definition of the WHO Integrated Management of Childhood Illness (IMCI).
Screening for pneumonia will be done every three months for one year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PM2.5 and CO exposure
Time Frame: 1 year
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Personal exposure to PM2.5 and CO will be measured for the primary cook using personal samplers
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1 year
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Respiratory symptoms
Time Frame: 1 year
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Measure incidence of respiratory symptoms, including cough, phlegm, wheeze and shortness of breath for the primary cook
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1 year
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Other related symptoms
Time Frame: 1 year
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Measure prevalence of other related symptoms, including headache and burning eyes for the primary cook
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Constant Paul Van Schayck, PhD, Maastricht University, Caphri School of Public Health and Primary Care
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 076-00051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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