Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves (STAR)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Asthma
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Improved Cookstoves
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion criteria:
- The household had a traditional wood burning cookstove and had at least one woman (primary cook) at least the age of 18, and one child between age 8-15 (both included).
- If a household had more than one child within the target age range, the oldest child within the age range was selected for study.
Exclusion criteria:
• Both the woman and the child could not successfully undertake spirometry.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
The intervention arm included households which received improved cookstoves
The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves.
Outcomes
Primary Outcome Measures
Forced Expiratory Volume 1 (FEV1)
The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).
Secondary Outcome Measures
Full Information
NCT ID
NCT03726957
First Posted
October 17, 2018
Last Updated
August 8, 2023
Sponsor
Boston College
Collaborators
Washington University School of Medicine, Sri Ramachandra University
1. Study Identification
Unique Protocol Identification Number
NCT03726957
Brief Title
Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves
Acronym
STAR
Official Title
Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 3, 2016 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston College
Collaborators
Washington University School of Medicine, Sri Ramachandra University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Household air pollution (HAP) is a leading risk factor for global burden of disease. Resource-constrained communities of the world especially women and children are significantly impacted by this challenge. To address household air pollution, cleaner and more efficient improved cookstoves (ICS) have been disseminated to low resource communities. Although there has been initial uptake of these stoves, sustained use has been inconsistent adding to the challenge of household air pollution. There is limited understanding at the intersections of social, ecological, and technical determinants of sustained use of ICS, and how is sustained use of ICS associated with exposure and health outcomes in poor communities.
The overarching goal of this exploratory study is to initiate a comprehensive research program that will facilitate the use of ICS and investigate whether they render significant health benefits among rural Indian households.
The investigators installed ICS (model: Eco-Chulla XXL) in select households that primarily use biomass for cooking, and evaluate the intervention based on three specific aims:
To generate preliminary emissions data [particulate matter - mass and surface area based, carbon monoxide (CO)] from ICS and its effect on respiratory health outcomes that will facilitate the development of a pivotal clean cookstove intervention
To generate effect size data that establish the feasibility and inform the sample size of a pivotal trial whose primary objective will be sustained improvements in the respiratory health of women and children in rural India
To evaluate factors which enable and hinder the sustained use of clean cookstove technologies by the rural poor in India so that the investigators can develop a more refined pivotal intervention focused on improving respiratory health
Detailed Description
In this study, the investigators undertake a 12-month cluster randomized trial in 96 households in the rural areas of Andhra Pradesh and Karnataka states of India. The investigators enrolled women (primary cook) and one child (age 8-15) in each of these 96 households. The investigators compare the effect of traditional wood burning stoves (the control condition) to that of improved wood burning stoves on the respiratory health of women and children, and also undertake community-based system dynamics modeling to delineate the feedback mechanisms involved in sustained use or abandonment of improved cookstoves. The study and research program are aligned with recent international attention to explore determinants impacting the sustained use of cleaner cooking systems in poor communities of the world. Thus, in achieving the aims of this R21, the investigators will then have: 1) necessary preliminary data; 2) pre-emptive strategies for most of these unanticipated but preventable challenges. The investigators will leverage these insights to proceed with a larger scale intervention: 1) to examine the effect of sustained use of cleaner cooking systems and respiratory health outcomes in women and children due to reduced HAP in rural India; 2) to explore barriers and enablers of implementation of cleaner cooking systems in multiple resource poor settings. Numerous studies have shown that sustained and exclusive use of cleaner cooking systems irrespective of their types have been a challenge. Lukewarm sustenance of cleaner cooking systems in poor households stems from a limited understanding on the grounds of social, technical, economic, and ecological intersections of energy security. The investigators intend to address this gap by using a trans-disciplinary approach to contribute to our understanding of factors that influence the implementation of cleaner cooking systems for rural poor in India.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Asthma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators adopted a cluster randomized controlled trial with village as the unit of randomization. Villages were randomized to have participating households assigned to either a traditional biomass burning cookstove (control group) or to an improved cookstove (intervention group). A household that was willing to participate was considered eligible: 1) if it had a traditional wood burning cookstove; and 2) if the household included at least one child between the ages of 8-15. If a household had more than one child within the target age range, the oldest child within the age range was selected for study. Study participants within each household were the mother and the selected child.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention arm included households which received improved cookstoves
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves.
Intervention Type
Behavioral
Intervention Name(s)
Improved Cookstoves
Intervention Description
Villages were randomized to have participating households assigned to either a traditional biomass burning cookstove or to an improved cookstove. Once the participating villages had been selected, the investigators used their list of eligible households within each village to randomly order these households. Within each village, the investigators then approached the eligible households in the order that had been randomly chosen and continued that process until four households within each village had agreed to participate. The selection of villages and households preceded randomization and was pursued with the clear understanding that group assignment would be random, and that participation reflected a willingness to be randomized to either study group.
Primary Outcome Measure Information:
Title
Forced Expiratory Volume 1 (FEV1)
Description
The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
The household had a traditional wood burning cookstove and had at least one woman (primary cook) at least the age of 18, and one child between age 8-15 (both included).
If a household had more than one child within the target age range, the oldest child within the age range was selected for study.
Exclusion criteria:
• Both the woman and the child could not successfully undertake spirometry.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30047157
Citation
Patel S, Leavey A, Sheshadri A, Kumar P, Kandikuppa S, Tarsi J, Mukhopadhyay K, Johnson P, Balakrishnan K, Schechtman KB, Castro M, Yadama G, Biswas P. Associations between household air pollution and reduced lung function in women and children in rural southern India. J Appl Toxicol. 2018 Nov;38(11):1405-1415. doi: 10.1002/jat.3659. Epub 2018 Jul 25.
Results Reference
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Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves
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