An interventional study of Cleaner cookstove received after visit 2 and Cleaner cookstove received after visit 4 in Blood Pressure, Inflammation and Glycated Hemoglobin (HbA1c), sponsored by Colorado State University. Completed at 1 site in Honduras. Open to female participants aged 24 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Colorado State University · Not applicable, Interventional, and Prevention
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:
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 222 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months)
Other: Cleaner cookstove received after visit 2
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)
Other: Cleaner cookstove received after visit 4
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2).
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).
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.
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 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.
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 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.
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 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)
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
The lab will analyze the dried blood spots for untargeted metabolomics after the completion of the study (not at each 6 month interval).
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
These outcomes will be assessed using the SphygmoCor XCEL.
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.
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Colorado State University