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

Primary Purpose

Signs and Symptoms, Respiratory, Air Pollution, Indoor

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
TEJ (Traditional stove to Efficient stove in Jhuggi)
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Signs and Symptoms, Respiratory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ashrayanagar slum
  • Mathikere slum
  • Muneshwaranagar slum
  • Peenya slum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi).

control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove.

Outcomes

Primary Outcome Measures

Lung function
Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook
Pneumonia
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
Personal exposure to PM2.5 and CO will be measured for the primary cook using personal samplers
Respiratory symptoms
Measure incidence of respiratory symptoms, including cough, phlegm, wheeze and shortness of breath for the primary cook
Other related symptoms
Measure prevalence of other related symptoms, including headache and burning eyes for the primary cook

Full Information

First Posted
June 21, 2016
Last Updated
March 9, 2021
Sponsor
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT02821650
Brief Title
A Study to Test the Impact of an Improved Chulha on Respiratory Health of Women and Children in Indian Slums
Official Title
Low-smoke Chulha in Indian Slums
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Because of COVID-19, we could complete the follow-ups
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 notified and non-notified slums in Bangalore, India. The study design is be a 1:1 randomised controlled intervention trial. 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.
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. 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 randomization 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Signs and Symptoms, Respiratory, Air Pollution, Indoor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention arm will be administered with improved cook stoves (TEJ- Traditional stove to Efficient stove in Jhuggi).
Arm Title
control
Arm Type
No Intervention
Arm Description
control arm will continue using traditional cook stoves (chulha) or a combination of the traditional stove and the kerosene/diesel stove.
Intervention Type
Other
Intervention Name(s)
TEJ (Traditional stove to Efficient stove in Jhuggi)
Intervention Description
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'
Primary Outcome Measure Information:
Title
Lung function
Description
Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook
Time Frame
1 year
Title
Pneumonia
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PM2.5 and CO exposure
Description
Personal exposure to PM2.5 and CO will be measured for the primary cook using personal samplers
Time Frame
1 year
Title
Respiratory symptoms
Description
Measure incidence of respiratory symptoms, including cough, phlegm, wheeze and shortness of breath for the primary cook
Time Frame
1 year
Title
Other related symptoms
Description
Measure prevalence of other related symptoms, including headache and burning eyes for the primary cook
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constant Paul Van Schayck, PhD
Organizational Affiliation
Maastricht University, Caphri School of Public Health and Primary Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashrayanagar slum
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560058
Country
India
Facility Name
Mathikere slum
City
Bangalore
Country
India
Facility Name
Muneshwaranagar slum
City
Bangalore
Country
India
Facility Name
Peenya slum
City
Bangalore
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28511647
Citation
Thakur M, Boudewijns EA, Babu GR, Winkens B, de Witte LP, Gruiskens J, Sushama P, Ghergu CT, van Schayck OCP. Low-smoke chulha in Indian slums: study protocol for a randomised controlled trial. BMC Public Health. 2017 May 16;17(1):454. doi: 10.1186/s12889-017-4369-6.
Results Reference
derived
Links:
URL
http://thorax.bmj.com/content/early/2018/06/20/thoraxjnl-2017-210952
Description
Related Info

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

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