Signs and Symptoms, RespiratoryNCT02821650
A Study to Test the Impact of an Improved Chulha on Respiratory Health of Women and Children in Indian Slums
A study testing TEJ (Traditional stove to Efficient stove in Jhuggi) in people with Signs and Symptoms, Respiratory and Air Pollution, Indoor, run by Maastricht University at 4 sites in India.
Trial summary
The present study documents a randomized controlled study investigating the efficacy of improved cookstove on the personal exposure to air pollution and the respiratory health of women and children in an Indian slum. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Respiratory, Air Pollution, Indoor
- What is being tested?
- TEJ (Traditional stove to Efficient stove in Jhuggi)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 4 sitesIndia
- Study dates
- 19 Apr 2017to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Households with a cooking area outside the house will be excluded
- Persons who are seriously ill will be excluded from the study
Trial locations and contacts
4 sites in 1 country.
India4 sites
Ashrayanagar slum
Bangalore, Karnataka, 560058
Mathikere slum
Bangalore
Muneshwaranagar slum
Bangalore
Peenya slum
Bangalore
About this study
Official title: Low-smoke Chulha in Indian Slums
The present study documents a randomized controlled study investigating the efficacy of improved cookstove on the personal exposure to air pollution and the respiratory health of women and children in an Indian slum. The improved cookstove is based on co-creation of a low-smoke chulha with local communities in order to support adaption and sustained uptake. The study is conducted in notified and non-notified slums in Bangalore, India. The study design is be a 1:1 randomised controlled intervention trial. Outcomes include change in lung function (FEV1/FVC), incidence of pneumonia, change in personal PM2.5 and CO exposure, incidence of respiratory symptoms (cough, phlegm, wheeze and shortness of breath), prevalence of other related symptoms (headache and burning eyes), change in behaviour and adoption of the stove.
Read the 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.
- Being tested
- TEJ (Traditional stove to Efficient stove in Jhuggi)
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEJ (Traditional stove to Efficient stove in Jhuggi)Other
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'
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi). Receives: Other: TEJ (Traditional stove to Efficient stove in Jhuggi) |
| control | No intervention | control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook
Measured: 1 year
Pneumonia
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
Measured: 1 year
Secondary outcomes (3)
PM2.5 and CO exposure
Personal exposure to PM2.5 and CO will be measured for the primary cook using personal samplers
Measured: 1 year
Respiratory symptoms
Measure incidence of respiratory symptoms, including cough, phlegm, wheeze and shortness of breath for the primary cook
Measured: 1 year
Other related symptoms
Measure prevalence of other related symptoms, including headache and burning eyes for the primary cook
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start19 Apr 2017
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: Because of COVID-19, we could complete the follow-ups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Signs and Symptoms, RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megha Thakur, Maastricht University
- Investigators
- Constant Paul Van Schayck, PhD, Principal investigator, Maastricht University, Caphri School of Public Health and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821650
- Sponsor's protocol ID
- 076-00051
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2016
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28511647
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-smoke Chulha in Indian Slums
- ClinicalTrials.gov ID
- NCT02821650
- Acronym / sponsor ID
- 076-00051
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of COVID-19, we could complete the follow-ups
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study documents a randomized controlled study investigating the efficacy of improved cookstove on the personal exposure to air pollution and the respiratory health of women and children in an Indian slum. The improved cookstove is based on co-creation of a low-smoke chulha with local communities in order to support adaption and sustained uptake. The study is conducted in notified and non-notified slums in Bangalore, India. The study design is be a 1:1 randomised controlled intervention trial. Outcomes include change in lung function (FEV1/FVC), incidence of pneumonia, change in personal PM2.5 and CO exposure, incidence of respiratory symptoms (cough, phlegm, wheeze and shortness of breath), prevalence of other related symptoms (headache and burning eyes), change in behaviour and adoption of the stove.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: TEJ (Traditional stove to Efficient stove in Jhuggi)Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi). |
| control | No intervention | –control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Households with a cooking area outside the house will be excluded
- Persons who are seriously ill will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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' | Other | Intervention |
Primary outcome
Lung function
Time frame: 1 year
Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook
Pneumonia
Time frame: 1 year
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
3 secondary outcomes
PM2.5 and CO exposure
Time frame: 1 year
Respiratory symptoms
Time frame: 1 year
Other related symptoms
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Because of COVID-19, we could complete the follow-ups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 28511647Thakur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constant Paul Van Schayck, PhD principal investigator
Maastricht University, Caphri School of Public Health and Primary Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEJ (Traditional stove to Efficient stove in Jhuggi) in people with Signs and Symptoms, Respiratory and Air Pollution, Indoor, run by Maastricht University at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of COVID-19, we could complete the follow-ups). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.