CClinicalTrials.gg
Active, not recruitingNCT03726957STARUpdated Jun 13, 2025

Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves

An interventional study of Improved Cookstoves in Chronic Obstructive Pulmonary Disease and Asthma, sponsored by Boston College. Active, not recruiting. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Boston College · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Nov 2014, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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. 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. 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. 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
Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Asthma
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 208 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Boston College is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion criteria:

  • Both the woman and the child could not successfully undertake spirometry.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
208 participants (actual)

Study arms

  • Experimental
    Intervention group

    The intervention arm included households which received improved cookstoves

    Behavioral: Improved Cookstoves

  • No intervention
    Control group

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

Interventions

  • BehavioralImproved 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.

06

What researchers measure

Primary outcomes

  1. Forced Expiratory Volume 1 (FEV1)

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

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 30047157 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03726957
Lead sponsor
Boston College
Collaborators
Washington University School of Medicine, Sri Ramachandra University
Responsible party
Sponsor
First posted
Nov 1, 2018
Start date
Nov 1, 2014
Primary completion
Dec 3, 2016
Completion
Dec 31, 2026 (estimated)
Last update
Jun 13, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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