Blood PressureNCT02658383
Community-Engaged Research: A Tool to Advance Cookstove Interventions
A study testing Cleaner cookstove received after visit 2 and Cleaner cookstove received after visit 4 in people with Blood Pressure and Inflammation, run by Colorado State University at 1 site in Honduras.
Trial summary
Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. Read more about this study
- Who is it for?
- Ages 24 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Inflammation, Glycated Hemoglobin (HbA1c)
- What is being tested?
- Cleaner cookstove received after visit 2 and Cleaner cookstove received after visit 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteHonduras
- Study dates
- Aug 2015to May 2018
- 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 24 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary cooks for the household
- Uses a traditional stove
- Latina women (representative of the rural Honduran population, no exclusions based on race/ethnicity)
Who cannot join
- Non-smoking
- Not pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-Based Participatory Research: A Tool to Advance Cookstove Interventions
Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. Indoor air pollution from biomass combustion accounts for an estimated 3.9 million premature deaths per year, representing about 4.8% of the global disease burden. Improved stove designs have the potential to substantially reduce indoor air pollution exposures. However, there are few randomized intervention trials, and previous stove intervention studies have been plagued by low improved stove adoption and sustained use, severely limiting interpretations of these studies. This research proposes to conduct community surveys and in-depth interviews among Honduran cookstove users to gain insight into the complex pathways surrounding barriers to and predictors of sustained improved cookstove adoption (among the target population for the proposed intervention). This information will be used to conduct and enhance a randomized improved cookstove intervention among 300 Honduran families, incorporating qualitative and quantitative measures of cookstove use and measuring pre- to post-intervention changes in pollutant exposures and subclinical indicators of cardiovascular health.
The primary goals are twofold:
Read more
- To incorporate community-engaged approaches throughout all aspects of the research
- To maximize sustained stove use (thereby maximizing the health impact of the intervention) to achieve valid exposure-response estimates.
Both objectives utilize innovative strategies to fill knowledge gaps. The research team will build upon previous studies in Latin America that have focused on identifying and validating appropriate field techniques for exposure and health assessments in rural areas of developing countries.
In summary, the proposed project will provide insight regarding barriers/predictors of sustained cookstove adoption, an issue impeding research in this field; assess the relationship between stove use and indicators of cardiovascular health, a substantial and quickly growing disease burden in developing countries; and result in a more comprehensive and valid assessment of the impact of a cookstove intervention.
- Conditions
- Blood Pressure, Inflammation, Glycated Hemoglobin (HbA1c)
- Being tested
- Cleaner cookstove received after visit 2, Cleaner cookstove received after visit 4
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleaner cookstove received after visit 2Other
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2).
Cleaner cookstove received after visit 4Other
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).
| Study group | Role | What they receive |
|---|---|---|
| Cleaner cookstove received after visit 2 | Experimental | This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months) Receives: Other: Cleaner cookstove received after visit 2 |
| Cleaner cookstove received after visit 4 | Experimental | This arm receives the cleaner cookstove later in the study (thus acting as a control arm until after visit 4 which is after approximately 1 yr and 6 months) Receives: Other: Cleaner cookstove received after visit 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood pressure
Intention to treat analyses will incorporate the repeated measures within participants and the change in blood pressure comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
Measured: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Change in glycated hemoglobin (HbA1c)
Intention to treat analyses will incorporate the repeated measures within participants and the change in HbA1c comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
Measured: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Change in C-reactive protein (CRP)
Intention to treat analyses will incorporate the repeated measures within participants and the change in CRP comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
Measured: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Secondary outcomes (3)
Change in Inflammation
Inflammatory markers will be measured in dried blood spots collected at each of 6 visits spaced approximately 6 months apart. Exhaled nitric oxide will also be measured at each visit to assess pulmonary inflammation (in a subset of the population). The lab will analyze the dried blood spots after the completion of the study (not at each 6 month interval); planned inflammatory markers (apart from C-reactive protein, which is a primary outcome) are intracellular adhesion molecule (ICAM-1), Serum amyloid A, and vascular endothelial cell adhesion molecule (VCAM-1)
Measured: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Change in metabolomics
The lab will analyze the dried blood spots for untargeted metabolomics after the completion of the study (not at each 6 month interval).
Measured: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Change in augmentation index and central pulse pressure
These outcomes will be assessed using the SphygmoCor XCEL.
Measured: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Maggie L Clark, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658383
- Sponsor's protocol ID
- 12-3870H
- Other IDs
- R00ES022269
- Status last verified
- Apr 2025
- First submitted
- 24 Aug 2015
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Young BN, Peel JL, Benka-Coker ML, Rajkumar S, Walker ES, Brook RD, Nelson TL, Volckens J, L'Orange C, Good N, Quinn C, Keller JP, Weller ZD, Africano S, Osorto Pinel AB, Clark ML. Study protocol for a stepped-wedge randomized cookstove intervention in rural Honduras: household air pollution and cardiometabolic health. BMC Public Health. 2019 Jul 8;19(1):903. doi: 10.1186/s12889-019-7214-2.
PubMed 31286921Young BN, Good N, Peel JL, Benka-Coker ML, Keller JP, Rajkumar S, Walker ES, Volckens J, L'Orange C, Quinn C, Africano S, Osorto Pinel AB, Clark ML. Reduced Black Carbon Concentrations following a Three-Year Stepped-Wedge Randomized Trial of the Wood-Burning Justa Cookstove in Rural Honduras. Environ Sci Technol Lett. 2022 Jun 14;9(6):538-542. doi: 10.1021/acs.estlett.2c00098. Epub 2022 May 4.
PubMed 38037640Benka-Coker ML, Young BN, Keller JP, Walker ES, Rajkumar S, Volckens J, Good N, Quinn C, L'Orange C, Weller ZD, Africano S, Osorto Pinel AB, Peel JL, Clark ML. Impact of the wood-burning Justa cookstove on fine particulate matter exposure: A stepped-wedge randomized trial in rural Honduras. Sci Total Environ. 2021 May 1;767:144369. doi: 10.1016/j.scitotenv.2020.144369. Epub 2020 Dec 29.
PubMed 33429278
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Participatory Research: A Tool to Advance Cookstove Interventions
- ClinicalTrials.gov ID
- NCT02658383
- Acronym / sponsor ID
- 12-3870H
- Conditions
- Blood Pressure, Inflammation, Glycated Hemoglobin (HbA1c)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Aug 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 18 Jan 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.
Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. Indoor air pollution from biomass combustion accounts for an estimated 3.9 million premature deaths per year, representing about 4.8% of the global disease burden. Improved stove designs have the potential to substantially reduce indoor air pollution exposures. However, there are few randomized intervention trials, and previous stove intervention studies have been plagued by low improved stove adoption and sustained use, severely limiting interpretations of these studies. This research proposes to conduct community surveys and in-depth interviews among Honduran cookstove users to gain insight into the complex pathways surrounding barriers to and predictors of sustained improved cookstove adoption (among the target population for the proposed intervention). This information will be used to conduct and enhance a randomized improved cookstove intervention among 300 Honduran families, incorporating qualitative and quantitative measures of cookstove use and measuring pre- to post-intervention changes in pollutant exposures and subclinical indicators of cardiovascular health.
The primary goals are twofold:
- To incorporate community-engaged approaches throughout all aspects of the research
- To maximize sustained stove use (thereby maximizing the health impact of the intervention) to achieve valid exposure-response estimates.
Both objectives utilize innovative strategies to fill knowledge gaps. The research team will build upon previous studies in Latin America that have focused on identifying and validating appropriate field techniques for exposure and health assessments in rural areas of developing countries.
In summary, the proposed project will provide insight regarding barriers/predictors of sustained cookstove adoption, an issue impeding research in this field; assess the relationship between stove use and indicators of cardiovascular health, a substantial and quickly growing disease burden in developing countries; and result in a more comprehensive and valid assessment of the impact of a cookstove intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleaner cookstove received after visit 2 | Experimental | Other: Cleaner cookstove received after visit 2This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months) |
| Cleaner cookstove received after visit 4 | Experimental | Other: Cleaner cookstove received after visit 4This arm receives the cleaner cookstove later in the study (thus acting as a control arm until after visit 4 which is after approximately 1 yr and 6 months) |
Who may qualify
- Ages
- 24 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primary cooks for the household
- Uses a traditional stove
- Latina women (representative of the rural Honduran population, no exclusions based on race/ethnicity)
Key exclusion criteria (2 listed)
- Non-smoking
- Not pregnant
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 |
|---|---|---|
| Cleaner cookstove received after visit 2The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2). | Other | Cleaner cookstove received after visit 2 |
| Cleaner cookstove received after visit 4The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4). | Other | Cleaner cookstove received after visit 4 |
Primary outcome
Change in Blood pressure
Time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Intention to treat analyses will incorporate the repeated measures within participants and the change in blood pressure comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
Change in glycated hemoglobin (HbA1c)
Time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Intention to treat analyses will incorporate the repeated measures within participants and the change in HbA1c comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
Change in C-reactive protein (CRP)
Time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Intention to treat analyses will incorporate the repeated measures within participants and the change in CRP comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
3 secondary outcomes
Change in Inflammation
Time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Change in metabolomics
Time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Change in augmentation index and central pulse pressure
Time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
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 4 Apr 2025.
- Background: PubMed 31286921Young BN, Peel JL, Benka-Coker ML, Rajkumar S, Walker ES, Brook RD, Nelson TL, Volckens J, L'Orange C, Good N, Quinn C, Keller JP, Weller ZD, Africano S, Osorto Pinel AB, Clark ML. Study protocol for a stepped-wedge randomized cookstove intervention in rural Honduras: household air pollution and cardiometabolic health. BMC Public Health. 2019 Jul 8;19(1):903. doi: 10.1186/s12889-019-7214-2.
- Results publication: PubMed 38037640Young BN, Good N, Peel JL, Benka-Coker ML, Keller JP, Rajkumar S, Walker ES, Volckens J, L'Orange C, Quinn C, Africano S, Osorto Pinel AB, Clark ML. Reduced Black Carbon Concentrations following a Three-Year Stepped-Wedge Randomized Trial of the Wood-Burning Justa Cookstove in Rural Honduras. Environ Sci Technol Lett. 2022 Jun 14;9(6):538-542. doi: 10.1021/acs.estlett.2c00098. Epub 2022 May 4.
- Results publication: PubMed 33429278Benka-Coker ML, Young BN, Keller JP, Walker ES, Rajkumar S, Volckens J, Good N, Quinn C, L'Orange C, Weller ZD, Africano S, Osorto Pinel AB, Peel JL, Clark ML. Impact of the wood-burning Justa cookstove on fine particulate matter exposure: A stepped-wedge randomized trial in rural Honduras. Sci Total Environ. 2021 May 1;767:144369. doi: 10.1016/j.scitotenv.2020.144369. Epub 2020 Dec 29.
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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.
Maggie L Clark, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleaner cookstove received after visit 2 and Cleaner cookstove received after visit 4 in people with Blood Pressure and Inflammation, run by Colorado State University at 1 site in Honduras.
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 3 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: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. 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?
Change in Blood pressure (time frame: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.). 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 NCT02658383, which also lists 3 linked publications.
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 4 Apr 2025.