Chronic Obstructive Pulmonary DiseaseSTARNCT03726957
Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves
A study testing Improved Cookstoves in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Boston College.
Trial summary
Household air pollution (HAP) is a leading risk factor for global burden of disease. Resource-constrained communities of the world especially women and children are significantly impacted by this challenge. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- What is being tested?
- Improved Cookstoves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The household had a traditional wood burning cookstove and had at least one woman (primary cook) at least the age of 18, and one child between age 8-15 (both included).
- If a household had more than one child within the target age range, the oldest child within the age range was selected for study.
Who cannot join
- Both the woman and the child could not successfully undertake spirometry.
About this study
Household air pollution (HAP) is a leading risk factor for global burden of disease. Resource-constrained communities of the world especially women and children are significantly impacted by this challenge. To address household air pollution, cleaner and more efficient improved cookstoves (ICS) have been disseminated to low resource communities. Although there has been initial uptake of these stoves, sustained use has been inconsistent adding to the challenge of household air pollution. There is limited understanding at the intersections of social, ecological, and technical determinants of sustained use of ICS, and how is sustained use of ICS associated with exposure and health outcomes in poor communities.
The overarching goal of this exploratory study is to initiate a comprehensive research program that will facilitate the use of ICS and investigate whether they render significant health benefits among rural Indian households.
Read more
The investigators installed ICS (model: Eco-Chulla XXL) in select households that primarily use biomass for cooking, and evaluate the intervention based on three specific aims:
- To generate preliminary emissions data [particulate matter - mass and surface area based, carbon monoxide (CO)] from ICS and its effect on respiratory health outcomes that will facilitate the development of a pivotal clean cookstove intervention
- To generate effect size data that establish the feasibility and inform the sample size of a pivotal trial whose primary objective will be sustained improvements in the respiratory health of women and children in rural India
- To evaluate factors which enable and hinder the sustained use of clean cookstove technologies by the rural poor in India so that the investigators can develop a more refined pivotal intervention focused on improving respiratory health
Read the detailed description
In this study, the investigators undertake a 12-month cluster randomized trial in 96 households in the rural areas of Andhra Pradesh and Karnataka states of India. The investigators enrolled women (primary cook) and one child (age 8-15) in each of these 96 households. The investigators compare the effect of traditional wood burning stoves (the control condition) to that of improved wood burning stoves on the respiratory health of women and children, and also undertake community-based system dynamics modeling to delineate the feedback mechanisms involved in sustained use or abandonment of improved cookstoves. The study and research program are aligned with recent international attention to explore determinants impacting the sustained use of cleaner cooking systems in poor communities of the world. Thus, in achieving the aims of this R21, the investigators will then have: 1) necessary preliminary data; 2) pre-emptive strategies for most of these unanticipated but preventable challenges. The investigators will leverage these insights to proceed with a larger scale intervention: 1) to examine the effect of sustained use of cleaner cooking systems and respiratory health outcomes in women and children due to reduced HAP in rural India; 2) to explore barriers and enablers of implementation of cleaner cooking systems in multiple resource poor settings. Numerous studies have shown that sustained and exclusive use of cleaner cooking systems irrespective of their types have been a challenge. Lukewarm sustenance of cleaner cooking systems in poor households stems from a limited understanding on the grounds of social, technical, economic, and ecological intersections of energy security. The investigators intend to address this gap by using a trans-disciplinary approach to contribute to our understanding of factors that influence the implementation of cleaner cooking systems for rural poor in India.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Being tested
- Improved Cookstoves
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved CookstovesBehavioural
Villages were randomized to have participating households assigned to either a traditional biomass burning cookstove or to an improved cookstove. Once the participating villages had been selected, the investigators used their list of eligible households within each village to randomly order these households. Within each village, the investigators then approached the eligible households in the order that had been randomly chosen and continued that process until four households within each village had agreed to participate. The selection of villages and households preceded randomization and was pursued with the clear understanding that group assignment would be random, and that participation reflected a willingness to be randomized to either study group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention arm included households which received improved cookstoves Receives: Behavioral: Improved Cookstoves |
| Control group | No intervention | The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume 1 (FEV1)
The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Nov 2014
- Primary completion3 Dec 2016
- Study completion31 Dec 2026 (estimated)
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators adopted a cluster randomized controlled trial with village as the unit of randomization. Villages were randomized to have participating households assigned to either a traditional biomass burning cookstove (control group) or to an improved cookstove (intervention group). A household that was willing to participate was considered eligible: 1) if it had a traditional wood burning cookstove; and 2) if the household included at least one child between the ages of 8-15. If a household had more than one child within the target age range, the oldest child within the age range was selected for study. Study participants within each household were the mother and the selected child.
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Sri Ramachandra University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726957
- Sponsor's protocol ID
- 1R21ES021585-01A1
- Acronym
- STAR
- Status last verified
- Jun 2025
- First submitted
- 17 Oct 2018
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel S, Leavey A, Sheshadri A, Kumar P, Kandikuppa S, Tarsi J, Mukhopadhyay K, Johnson P, Balakrishnan K, Schechtman KB, Castro M, Yadama G, Biswas P. Associations between household air pollution and reduced lung function in women and children in rural southern India. J Appl Toxicol. 2018 Nov;38(11):1405-1415. doi: 10.1002/jat.3659. Epub 2018 Jul 25.
PubMed 30047157
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves
- ClinicalTrials.gov ID
- NCT03726957
- Acronym / sponsor ID
- STAR / 1R21ES021585-01A1
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Sri Ramachandra University
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 3 Dec 2016 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Nov 2018 (actual)
- 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.
Household air pollution (HAP) is a leading risk factor for global burden of disease. Resource-constrained communities of the world especially women and children are significantly impacted by this challenge. To address household air pollution, cleaner and more efficient improved cookstoves (ICS) have been disseminated to low resource communities. Although there has been initial uptake of these stoves, sustained use has been inconsistent adding to the challenge of household air pollution. There is limited understanding at the intersections of social, ecological, and technical determinants of sustained use of ICS, and how is sustained use of ICS associated with exposure and health outcomes in poor communities.
The overarching goal of this exploratory study is to initiate a comprehensive research program that will facilitate the use of ICS and investigate whether they render significant health benefits among rural Indian households.
The investigators installed ICS (model: Eco-Chulla XXL) in select households that primarily use biomass for cooking, and evaluate the intervention based on three specific aims:
- To generate preliminary emissions data [particulate matter - mass and surface area based, carbon monoxide (CO)] from ICS and its effect on respiratory health outcomes that will facilitate the development of a pivotal clean cookstove intervention
- To generate effect size data that establish the feasibility and inform the sample size of a pivotal trial whose primary objective will be sustained improvements in the respiratory health of women and children in rural India
- To evaluate factors which enable and hinder the sustained use of clean cookstove technologies by the rural poor in India so that the investigators can develop a more refined pivotal intervention focused on improving respiratory health
Detailed description
In this study, the investigators undertake a 12-month cluster randomized trial in 96 households in the rural areas of Andhra Pradesh and Karnataka states of India. The investigators enrolled women (primary cook) and one child (age 8-15) in each of these 96 households. The investigators compare the effect of traditional wood burning stoves (the control condition) to that of improved wood burning stoves on the respiratory health of women and children, and also undertake community-based system dynamics modeling to delineate the feedback mechanisms involved in sustained use or abandonment of improved cookstoves. The study and research program are aligned with recent international attention to explore determinants impacting the sustained use of cleaner cooking systems in poor communities of the world. Thus, in achieving the aims of this R21, the investigators will then have: 1) necessary preliminary data; 2) pre-emptive strategies for most of these unanticipated but preventable challenges. The investigators will leverage these insights to proceed with a larger scale intervention: 1) to examine the effect of sustained use of cleaner cooking systems and respiratory health outcomes in women and children due to reduced HAP in rural India; 2) to explore barriers and enablers of implementation of cleaner cooking systems in multiple resource poor settings. Numerous studies have shown that sustained and exclusive use of cleaner cooking systems irrespective of their types have been a challenge. Lukewarm sustenance of cleaner cooking systems in poor households stems from a limited understanding on the grounds of social, technical, economic, and ecological intersections of energy security. The investigators intend to address this gap by using a trans-disciplinary approach to contribute to our understanding of factors that influence the implementation of cleaner cooking systems for rural poor in India.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators adopted a cluster randomized controlled trial with village as the unit of randomization. Villages were randomized to have participating households assigned to either a traditional biomass burning cookstove (control group) or to an improved cookstove (intervention group). A household that was willing to participate was considered eligible: 1) if it had a traditional wood burning cookstove; and 2) if the household included at least one child between the ages of 8-15. If a household had more than one child within the target age range, the oldest child within the age range was selected for study. Study participants within each household were the mother and the selected child.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Improved CookstovesThe intervention arm included households which received improved cookstoves |
| Control group | No intervention | –The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The household had a traditional wood burning cookstove and had at least one woman (primary cook) at least the age of 18, and one child between age 8-15 (both included).
- If a household had more than one child within the target age range, the oldest child within the age range was selected for study.
Key exclusion criteria (1 listed)
- Both the woman and the child could not successfully undertake spirometry.
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 |
|---|---|---|
| Improved CookstovesVillages were randomized to have participating households assigned to either a traditional biomass burning cookstove or to an improved cookstove. Once the participating villages had been selected, the investigators used their list of eligible households within each village to randomly order these households. Within each village, the investigators then approached the eligible households in the order that had been randomly chosen and continued that process until four households within each village had agreed to participate. The selection of villages and households preceded randomization and was pursued with the clear understanding that group assignment would be random, and that participation reflected a willingness to be randomized to either study group. | Behavioural | Intervention group |
Primary outcome
Forced Expiratory Volume 1 (FEV1)
Time frame: 12 months
The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 30047157Patel S, Leavey A, Sheshadri A, Kumar P, Kandikuppa S, Tarsi J, Mukhopadhyay K, Johnson P, Balakrishnan K, Schechtman KB, Castro M, Yadama G, Biswas P. Associations between household air pollution and reduced lung function in women and children in rural southern India. J Appl Toxicol. 2018 Nov;38(11):1405-1415. doi: 10.1002/jat.3659. Epub 2018 Jul 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Improved Cookstoves in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Boston College.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Forced Expiratory Volume 1 (FEV1) (time frame: 12 months). 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 NCT03726957, 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 13 Jun 2025.