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Community-Engaged Research: A Tool to Advance Cookstove Interventions

Primary Purpose

Blood Pressure, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Honduras
Study Type
Interventional
Intervention
Cleaner cookstove received after visit 2
Cleaner cookstove received after visit 4
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure

Eligibility Criteria

24 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Field site in Honduras

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cleaner cookstove received after visit 2

Cleaner cookstove received after visit 4

Arm Description

This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
August 24, 2015
Last Updated
July 10, 2018
Sponsor
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT02658383
Brief Title
Community-Engaged Research: A Tool to Advance Cookstove Interventions
Official Title
Community-Based Participatory Research: A Tool to Advance Cookstove Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cleaner cookstove received after visit 2
Arm Type
Experimental
Arm Description
This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months)
Arm Title
Cleaner cookstove received after visit 4
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Cleaner cookstove received after visit 2
Intervention Description
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2).
Intervention Type
Other
Intervention Name(s)
Cleaner cookstove received after visit 4
Intervention Description
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).
Primary Outcome Measure Information:
Title
Change in Blood pressure
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in Inflammation
Description
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)
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie L Clark, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Field site in Honduras
City
La Esperanza
State/Province
Intibuca
Country
Honduras

12. IPD Sharing Statement

Citations:
PubMed Identifier
33429278
Citation
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.
Results Reference
derived
PubMed Identifier
31286921
Citation
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.
Results Reference
derived

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Community-Engaged Research: A Tool to Advance Cookstove Interventions

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