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A Study to Test the Impact of an Improved Chulha on Respiratory Health of Women and Children in Indian Slums

This study is currently recruiting participants.
Verified April 2017 by Megha Thakur, Maastricht University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02821650
First Posted: July 1, 2016
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Megha Thakur, Maastricht University
  Purpose
The present study documents a randomized controlled study investigating the efficacy of improved cookstove on the personal exposure to air pollution and the respiratory health of women and children in an Indian slum. The improved cookstove is based on co-creation of a low-smoke chulha with local communities in order to support adaption and sustained uptake. The study is conducted in a non-notified slum in Bangalore, India. The study design is be a 1:1 randomised controlled intervention trial, including 250 households. Outcomes include change in lung function (FEV1/FVC), incidence of pneumonia, change in personal PM2.5 and CO exposure, incidence of respiratory symptoms (cough, phlegm, wheeze and shortness of breath), prevalence of other related symptoms (headache and burning eyes), change in behaviour and adoption of the stove.

Condition Intervention
Signs and Symptoms, Respiratory Air Pollution, Indoor Other: TEJ (Traditional stove to Efficient stove in Jhuggi)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low-smoke Chulha in Indian Slums

Further study details as provided by Megha Thakur, Maastricht University:

Primary Outcome Measures:
  • Lung function [ Time Frame: 1 year ]
    Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook

  • Pneumonia [ Time Frame: 1 year ]
    Measure incidence of pneumonia for children ≤5 years. The incidence of pneumonia for children ≤5 years will be determined according to the definition of the WHO Integrated Management of Childhood Illness (IMCI). Screening for pneumonia will be done every three months for one year


Secondary Outcome Measures:
  • PM2.5 and CO exposure [ Time Frame: 1 year ]
    Personal exposure to PM2.5 and CO will be measured for the primary cook using personal samplers

  • Respiratory symptoms [ Time Frame: 1 year ]
    Measure incidence of respiratory symptoms, including cough, phlegm, wheeze and shortness of breath for the primary cook

  • Other related symptoms [ Time Frame: 1 year ]
    Measure prevalence of other related symptoms, including headache and burning eyes for the primary cook

  • Adoption of the improved cookstove [ Time Frame: 1 year ]
    Assess change in behaviour and attitudes of user and adoption of the improved cookstove using semi-structured interview


Estimated Enrollment: 250
Actual Study Start Date: April 19, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi).
Other: TEJ (Traditional stove to Efficient stove in Jhuggi)
TEJ (means 'Bright' in Hindi) is an improved cook stove, locally designed and manufactured, aimed at reducing the indoor air emissions and improving health outcomes. 'Jhuggi' is a Hindi word which stands for a 'slum dwelling'
No Intervention: control
control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove.

Detailed Description:

Noting the significant health impact of the use of solid fuels and traditional cooking systems on (public) health indicators, it is imperative to find clean cooking solutions for urban slum dwelling communities. While several efforts have been made to reduce indoor air pollution in India, most efforts focused on "enhancing stove energy efficiency, and not reducing emissions." Also, use of a strict top-down approach in the community was responsible for many unsuccessful projects. The current project is based on principles of co-creation, involving the local community in designing and producing clean cook stoves; a more scalable and sustainable solution than fully subsidized efforts.

The aim of the present trial is to reduce the levels of household air pollution and improve the respiratory health of women and children by using a locally designed and manufactured improved cook stove. The study design will be a 1:1 randomised controlled intervention trial.

The intervention group will receive a locally designed and manufactured improved cookstove (low-smoke chulha). The control group will continue using the traditional cookstove (chulha) or a combination of the traditional stove and the kerosene/diesel stove.

The first part of project EXHALE was based upon an iterative process of co-creation of a low-smoke chulha with local communities in order to support adaption and sustained uptake. A qualitative study was conducted to gain insight into the cooking practices and challenges faced with the traditional stoves. Workshops were conducted where people were involved in creating an ideal stove, using thermocol blocks. Feedback was continuously used to optimize the design of the cookstove. Improved cookstoves were evaluated in a qualitative study in a slum called Siddhaarthanagar colony in Peenya, Bangalore.

A total of at least 250 households with at least one child aged 5 years or younger will be selected in this study. Both eligible households with and without children will be included. The study will be extended to other slums, in case the sample size could not be met in Ashrayanagar slum. Block randomization will be performed to reduce bias and achieve balance in the allocation of participants to treatment arms. Block sizes vary between two, four and six households to reduce the possibility of knowing the next randomisation allocation. The study will be single-blinded (data-analyst). Randomization is stratified for having a child aged 5 years or younger or not.

Data for the questionnaires and for the assessment of pneumonia will be collected using a tablet computer with a pre-formatted questionnaire sheet. All data collection and storage devices will be password protected. Only supervisors and the main researcher will have access to the data files, identifiers, and keys. An intention-to-treat analysis will be conducted in order to ensure external validity of the study and minimize bias.

Since the intervention is not a clinical intervention, and does not have adverse effect on the participants, a data monitoring committee has not been formed. However, to review and keep track of the progress of the trial, a clinical advisory committee comprising of relevant experts has been formed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Woman ≥18 years who cooked more than 50% of the meals during the past 30 days (primary cook) and one child per household (0-5 years) will be included
  • Both households with and without children will be included
  • Women/mothers who are capable of being interviewed
  • Will not migrate in the upcoming 2 months as far as the participants can predict
  • Households cooking solely with traditional stove (chulha) or a combination of a traditional stove and a kerosene/diesel stove will be included

Exclusion Criteria:

  • Households with a cooking area outside the house will be excluded
  • Persons who are seriously ill will be excluded from the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821650


Contacts
Contact: Megha Thakur, MPH +91-9538537091 meghathakur@iiphh.org
Contact: Giridhara Babu, PhD +91-080-23206124 giridhar@iiphh.org

Locations
India
Ashrayanagar Recruiting
Bangalore, Karnataka, India, 560058
Contact: Megha Thakur       meghathakur@iiphh.org   
Sponsors and Collaborators
Maastricht University
Investigators
Principal Investigator: Constant Paul Van Schayck, PhD Maastricht University, Caphri School of Public Health and Primary Care
  More Information

Responsible Party: Megha Thakur, External PhD student at CAPHRI school of public health and primary care, Maastricht University
ClinicalTrials.gov Identifier: NCT02821650     History of Changes
Other Study ID Numbers: 076-00051
First Submitted: June 21, 2016
First Posted: July 1, 2016
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Respiratory