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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
Boston College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 17, 2018
    Last Updated
    August 8, 2023
    Sponsor
    Boston College
    Collaborators
    Washington University School of Medicine, Sri Ramachandra University
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    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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