- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02658383
Community-Engaged Research: A Tool to Advance Cookstove Interventions
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:
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Intibuca
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La Esperanza, Intibuca, Honduras
- Field site in Honduras
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary cooks for the household
- Uses a traditional stove
- Latina women (representative of the rural Honduran population, no exclusions based on race/ethnicity)
Exclusion Criteria:
- Non-smoking
- Not pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cleaner cookstove received after visit 2
This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months)
|
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2).
|
Experimental: Cleaner cookstove received after visit 4
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)
|
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 the two research arms 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
The lab will analyze the dried blood spots after the completion of the study (not at each 6 month interval); planned inflammatory markers include C-reactive protein, intracellular adhesion molecule (ICAM-1), Serum amyloid A, and vascular endothelial cell adhesion molecule (VCAM-1)
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maggie L Clark, PhD, Colorado State University
Publications and helpful links
General Publications
- Benka-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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R00ES022269 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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