NCT02658383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

August 24, 2015

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Blood pressure

    Intention to treat analyses will incorporate the repeated measures within participants and the change in blood pressure comparing assigned stove type 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.

  • Change in glycated hemoglobin (HbA1c)

    Intention to treat analyses will incorporate the repeated measures within participants and the change in HbA1c comparing assigned stove type 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.

  • Change in C-reactive protein (CRP)

    Intention to treat analyses will incorporate the repeated measures within participants and the change in CRP comparing assigned stove type 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 Outcomes (3)

  • Change in Inflammation

    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.

  • Change in metabolomics

    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.

  • Change in augmentation index and central pulse pressure

    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.

Study Arms (2)

Cleaner cookstove received after visit 2

EXPERIMENTAL

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

Cleaner cookstove received after visit 4

EXPERIMENTAL

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

Interventions

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 2

The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).

Cleaner cookstove received after visit 4

Eligibility Criteria

Age24 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primary cooks for the household
  • Uses a traditional stove

You may not qualify if:

  • Non-smoking
  • Not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Field site in Honduras

La Esperanza, Intibucá Department, Honduras

Location

Related Publications (3)

  • 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.

    PMID: 31286921BACKGROUND
  • Young BN, Good N, Peel JL, Benka-Coker ML, Keller JP, Rajkumar S, Walker ES, Volckens J, L'Orange C, Quinn C, Africano S, Osorto Pinel AB, Clark ML. Reduced Black Carbon Concentrations following a Three-Year Stepped-Wedge Randomized Trial of the Wood-Burning Justa Cookstove in Rural Honduras. Environ Sci Technol Lett. 2022 Jun 14;9(6):538-542. doi: 10.1021/acs.estlett.2c00098. Epub 2022 May 4.

  • 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.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maggie L Clark, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

January 18, 2016

Study Start

August 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations