Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves (STAR)
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|ClinicalTrials.gov Identifier: NCT03726957|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : January 14, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease Asthma||Behavioral: Improved Cookstoves||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Primary Purpose:||Basic Science|
|Official Title:||Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves|
|Actual Study Start Date :||November 1, 2014|
|Actual Primary Completion Date :||December 3, 2016|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Intervention group
The intervention arm included households which received improved cookstoves
Behavioral: Improved Cookstoves
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.
No Intervention: Control group
The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves.
- Forced Expiratory Volume 1 (FEV1) [ Time Frame: 12 months ]The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).