Community-Engaged Research: A Tool to Advance Cookstove Interventions

• ClinicalTrials.gov Identifier: NCT02658383
• Recruitment Status: Completed
• First Posted: January 18, 2016
• Last Update Posted: July 12, 2018
• Sponsor: Colorado State University
• Information provided by (Responsible Party): Colorado State University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure; Inflammation	Other: Cleaner cookstove received after visit 2; Other: Cleaner cookstove received after visit 4	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community-Based Participatory Research: A Tool to Advance Cookstove Interventions
• Study Start Date: August 2015
• Actual Primary Completion Date: May 2018
• Actual Study Completion Date: May 2018

Arms and Interventions

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)	Other: Cleaner cookstove received after visit 2; 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)	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 4).

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 24 Years to 59 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Honduras

Field site in Honduras

La Esperanza, Intibuca, Honduras

Sponsors and Collaborators

Colorado State University

Investigators

• Principal Investigator: Maggie L Clark, PhD; Colorado State University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 2020 Dec 29;767:144369. doi: 10.1016/j.scitotenv.2020.144369. [Epub ahead of print]

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.

• Responsible Party: Colorado State University
• ClinicalTrials.gov Identifier: NCT02658383
• Other Study ID Numbers: R00ES022269 ( U.S. NIH Grant/Contract )
• First Posted: January 18, 2016
• Last Update Posted: July 12, 2018
• Last Verified: February 2018

Additional relevant MeSH terms:

Inflammation; Pathologic Processes