Community-Engaged Research: A Tool to Advance Cookstove Interventions

Inflammation Clinical Trial

Official title:

Community-Based Participatory Research: A Tool to Advance Cookstove Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658383
• Other study ID #: R00ES022269
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2018
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Inflammation

Intervention

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).
• 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).

Locations

Country	Name	City	State
Honduras	Field site in Honduras	La Esperanza	Intibuca

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood pressure	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	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. 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.