Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Community-Engaged Research: A Tool to Advance Cookstove Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658383
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Colorado State University

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

Layout table for study information
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

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).




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658383


Locations
Layout table for location information
Honduras
Field site in Honduras
La Esperanza, Intibuca, Honduras
Sponsors and Collaborators
Colorado State University
Investigators
Layout table for investigator information
Principal Investigator: Maggie L Clark, PhD Colorado State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT02658383     History of Changes
Other Study ID Numbers: R00ES022269 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes