Poisoning by Carbon Monoxide From Domestic FuelsNCT01686867
Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries
A study testing Improved, ventilated cookstove in people with Poisoning by Carbon Monoxide From Domestic Fuels and Respiratory Conditions Due to Other External Agents, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 3 countries.
Trial summary
The underlying concept behind this feasibility trial is to achieve a reduction in indoor smoke from biomass fuels and minimize changes in cooking practices such that it prompts one of the two improved, ventilated cookstoves to be the selection of choice. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poisoning by Carbon Monoxide From Domestic Fuels, Respiratory Conditions Due to Other External Agents
- What is being tested?
- Improved, ventilated cookstove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2012to May 2014
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have at least one woman aged 20 to 49 years who is the main cook.
- Have a traditional (i.e., open-fire) cookstove indoors with at least 3 walls and a roof.
- Are willing to have us install an improved cookstove and be willing to use it.
- Have household walls of mud, brick, cement, or wood.
- Capable of providing informed consent and responding to a questionnaire
- Full-time resident in the area
Who cannot join
- Have a new improved cookstove or a chimney in the household.
- Have household walls of thatch or bamboo no covered in mud.
- Plans to move from the area within one year.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The underlying concept behind this feasibility trial is to achieve a reduction in indoor smoke from biomass fuels and minimize changes in cooking practices such that it prompts one of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel sources used in developing countries include wood, dried dung, and agricultural waste. The investigators propose to reduce indoor air pollution by replacing the household traditional cookstove with an improved design that incorporates the following key elements:
- Burner openings customized to the size and shape of the cooking vessels in the home.
- Flue designed to draw air into the fire box under the cooking pots and pass it out through a chimney.
- A chimney with adequate height to create a draft and vented to the exterior.
- An exterior port that has bidirectional openings to prevent backflow of smoke.
- An access port for the chimney that permits cleaning of soot.
Read more
The investigators propose to use two types of improved cookstoves that meet these criteria. As part of piloting activities, the investigators will test several different types of commercially-available cookstoves with a chimney, and we may also want to test a locally-made improved cookstove. The investigators want to evaluate those designs by comparing their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functioning over time, the logistics of import/build locally, preferences and cultural compatibility, and costs. The investigators will select two types of improved cookstoves to use in the feasibility trial.
The study design will be a crossover intervention trial in which all patients will first have a run-in observational period of 4 months with the traditional cookstove prior to randomization. At baseline, the investigators will obtain sociodemographic information for each household, respiratory outcomes and other health data for the participating women, and cooking times and practices including the types of fuels used. All 40 patients at each site will receive the two types of improved cookstoves, one after the other: 20 will be randomized to receive the first type of cookstove with a chimney and the other 20 to first receive the second type of improved cookstove with a chimney. The patients will be followed for 4 months before the crossover. The investigators will assess cooking behavioral practices and compliance with cookstove use monthly, and respiratory and environmental measures at the mid-point of the 4 month period to minimize carry-over effects. At the end of second 4 month period, the investigators will switch the order of the improved cookstoves and follow all participants for another 4 months. The investigators will assess behavior, compliance, respiratory and environmental measures as above. The study is expected to require 12 months to complete.
- Conditions
- Poisoning by Carbon Monoxide From Domestic Fuels, Respiratory Conditions Due to Other External Agents
- Being tested
- Improved, ventilated cookstove
- Keywords
- improved cookstove, ventilated cookstove, behavior change, adoption, indoor air pollution, DLCO, spirometry, biomass fuel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved, ventilated cookstoveDevice
An improved, ventilated cookstove incorporates the following key elements: burner openings customized to the size and shape of the cooking utensils; a flue designed to draw air into the fire box and pass it out through a chimney; a chimney, vented to the exterior, of adequate height to create a draft; an exterior port that has bidirectional openings to prevent the backflow of smoke and an access port for the chimney that permits cleaning.
The investigators piloted cookstoves prior to the trial and compared their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functionality over time, preferences and cultural compatibility, and cost. The investigators selected the the Envirofit G-3300/3355, a modified Stovetec cookstove with a chimney and a locally-made improved, ventilated cookstove for use in the trial.
| Study group | Role | What they receive |
|---|---|---|
| Commercially-made followed by locally-made improved cookstove | Experimental | Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. Four months later the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period. Receives: Device: Improved, ventilated cookstove |
| Locally-made followed by commercially-made improved cookstove | Experimental | Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. Four months later the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period. Receives: Device: Improved, ventilated cookstove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to biomass fuel combustion
Measure change in levels of particulate matter concentrations and carbon monoxide between traditional cookstoves and improved, ventilated cookstoves in households in three rural populations in which biomass fuels are used almost exclusively for cooking.
Measured: One year
Respiratory Outcomes
Measure change in respiratory outcomes (spirometry for FEV1 and peak expiratory flow, carboxyhemoglobin and DLCO) in women aged 20 to 49 years in three rural populations between traditional cookstoves and the improved, ventilated cookstoves.
Measured: One year
Adoption process of improved cookstoves
Assess behaviors and attitudes in women 20-49 years of age in three rural populations regarding the adoption and continued use of improved cookstoves and evaluate the reasons for their preferred choice of cookstove at the end of the trial. Methodology includes: patient direct observations, in-depth interviews, semi-structured interviews and focus groups with study staff.
Measured: One year
Secondary outcomes (1)
Blood pressure
Measure change in blood pressure in women 20 to 49 years of age in three rural populations between traditional cookstoves and improved, ventilated cookstoves.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionMay 2014
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 Poisoning by Carbon Monoxide From Domestic FuelsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, National Institutes of Health (NIH), Brown University, Moi University, Asociacion Benefica Prisma, Nepal Nutrition Intervention Project Sarlahi
- Responsible party
- Principal investigator, William Checkley, Johns Hopkins Bloomberg School of Public Health
- Investigators
- William Checkley, MD, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686867
- Sponsor's protocol ID
- COCINAS
- Other IDs
- HHSN268200900033C
- Status last verified
- Apr 2015
- First submitted
- 10 Sep 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Klasen E, Miranda JJ, Khatry S, Menya D, Gilman RH, Tielsch JM, Kennedy C, Dreibelbis R, Naithani N, Kimaiyo S, Chiang M, Carter EJ, Sherman CB, Breysse PN, Checkley W; COCINAS Trial Working Group. Feasibility intervention trial of two types of improved cookstoves in three resource-limited settings: study protocol for a randomized controlled trial. Trials. 2013 Oct 10;14:327. doi: 10.1186/1745-6215-14-327.
PubMed 24112419
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries
- ClinicalTrials.gov ID
- NCT01686867
- Acronym / sponsor ID
- COCINAS
- Conditions
- Poisoning by Carbon Monoxide From Domestic Fuels, Respiratory Conditions Due to Other External Agents
- Keywords
- improved cookstove, ventilated cookstove, behavior change, adoption, indoor air pollution, DLCO, spirometry, biomass fuel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, National Institutes of Health (NIH), Brown University, Moi University, Asociacion Benefica Prisma, Nepal Nutrition Intervention Project Sarlahi
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Sep 2012 (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 underlying concept behind this feasibility trial is to achieve a reduction in indoor smoke from biomass fuels and minimize changes in cooking practices such that it prompts one of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel sources used in developing countries include wood, dried dung, and agricultural waste. The investigators propose to reduce indoor air pollution by replacing the household traditional cookstove with an improved design that incorporates the following key elements:
- Burner openings customized to the size and shape of the cooking vessels in the home.
- Flue designed to draw air into the fire box under the cooking pots and pass it out through a chimney.
- A chimney with adequate height to create a draft and vented to the exterior.
- An exterior port that has bidirectional openings to prevent backflow of smoke.
- An access port for the chimney that permits cleaning of soot.
The investigators propose to use two types of improved cookstoves that meet these criteria. As part of piloting activities, the investigators will test several different types of commercially-available cookstoves with a chimney, and we may also want to test a locally-made improved cookstove. The investigators want to evaluate those designs by comparing their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functioning over time, the logistics of import/build locally, preferences and cultural compatibility, and costs. The investigators will select two types of improved cookstoves to use in the feasibility trial.
The study design will be a crossover intervention trial in which all patients will first have a run-in observational period of 4 months with the traditional cookstove prior to randomization. At baseline, the investigators will obtain sociodemographic information for each household, respiratory outcomes and other health data for the participating women, and cooking times and practices including the types of fuels used. All 40 patients at each site will receive the two types of improved cookstoves, one after the other: 20 will be randomized to receive the first type of cookstove with a chimney and the other 20 to first receive the second type of improved cookstove with a chimney. The patients will be followed for 4 months before the crossover. The investigators will assess cooking behavioral practices and compliance with cookstove use monthly, and respiratory and environmental measures at the mid-point of the 4 month period to minimize carry-over effects. At the end of second 4 month period, the investigators will switch the order of the improved cookstoves and follow all participants for another 4 months. The investigators will assess behavior, compliance, respiratory and environmental measures as above. The study is expected to require 12 months to complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercially-made followed by locally-made improved cookstove | Experimental | Device: Improved, ventilated cookstoveFollowing a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. Four months later the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period. |
| Locally-made followed by commercially-made improved cookstove | Experimental | Device: Improved, ventilated cookstoveFollowing a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. Four months later the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have at least one woman aged 20 to 49 years who is the main cook.
- Have a traditional (i.e., open-fire) cookstove indoors with at least 3 walls and a roof.
- Are willing to have us install an improved cookstove and be willing to use it.
- Have household walls of mud, brick, cement, or wood.
- Capable of providing informed consent and responding to a questionnaire
Key exclusion criteria (3 listed)
- Have a new improved cookstove or a chimney in the household.
- Have household walls of thatch or bamboo no covered in mud.
- Plans to move from the area within one year.
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, ventilated cookstoveAn improved, ventilated cookstove incorporates the following key elements: burner openings customized to the size and shape of the cooking utensils; a flue designed to draw air into the fire box and pass it out through a chimney; a chimney, vented to the exterior, of adequate height to create a draft; an exterior port that has bidirectional openings to prevent the backflow of smoke and an access port for the chimney that permits cleaning. The investigators piloted cookstoves prior to the trial and compared their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functionality over time, preferences and cultural compatibility, and cost. The investigators selected the the Envirofit G-3300/3355, a modified Stovetec cookstove with a chimney and a locally-made improved, ventilated cookstove for use in the trial. | Device | Commercially-made followed by locally-made improved cookstove, Locally-made followed by commercially-made improved cookstove |
Primary outcome
Exposure to biomass fuel combustion
Time frame: One year
Measure change in levels of particulate matter concentrations and carbon monoxide between traditional cookstoves and improved, ventilated cookstoves in households in three rural populations in which biomass fuels are used almost exclusively for cooking.
Respiratory Outcomes
Time frame: One year
Measure change in respiratory outcomes (spirometry for FEV1 and peak expiratory flow, carboxyhemoglobin and DLCO) in women aged 20 to 49 years in three rural populations between traditional cookstoves and the improved, ventilated cookstoves.
Adoption process of improved cookstoves
Time frame: One year
Assess behaviors and attitudes in women 20-49 years of age in three rural populations regarding the adoption and continued use of improved cookstoves and evaluate the reasons for their preferred choice of cookstove at the end of the trial. Methodology includes: patient direct observations, in-depth interviews, semi-structured interviews and focus groups with study staff.
1 secondary outcome
Blood pressure
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 24112419Klasen E, Miranda JJ, Khatry S, Menya D, Gilman RH, Tielsch JM, Kennedy C, Dreibelbis R, Naithani N, Kimaiyo S, Chiang M, Carter EJ, Sherman CB, Breysse PN, Checkley W; COCINAS Trial Working Group. Feasibility intervention trial of two types of improved cookstoves in three resource-limited settings: study protocol for a randomized controlled trial. Trials. 2013 Oct 10;14:327. doi: 10.1186/1745-6215-14-327.
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.
William Checkley, MD, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved, ventilated cookstove in people with Poisoning by Carbon Monoxide From Domestic Fuels and Respiratory Conditions Due to Other External Agents, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 3 countries.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya, Nepal, Peru. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exposure to biomass fuel combustion (time frame: One year). The study lists 3 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 NCT01686867, 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 3 Apr 2015.