Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves

NCT03726957 | Active Not Recruiting DMC

• 1 other identifier: 1R21ES021585-01A1
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

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:

1. 1.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
2. 2.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
3. 3.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

Conditions

Chronic Obstructive Pulmonary Disease; Asthma

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume 1 (FEV1)

  The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention arm included households which received improved cookstoves

Behavioral: Improved Cookstoves

Control group

NO INTERVENTION

The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves.

Interventions

Improved Cookstoves BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Both the woman and the child could not successfully undertake spirometry.

Sponsors & Collaborators

• Boston College: lead
• Washington University School of Medicine: collaborator
• Sri Ramachandra University: collaborator

Related Publications (1)

• 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.

  PMID: 30047157 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 1, 2018
• Study Start: November 1, 2014
• Primary Completion: December 3, 2016
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share