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

NCT ID: NCT02821650

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2020-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Signs and Symptoms, Respiratory Air Pollution, Indoor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

TEJ (Traditional stove to Efficient stove in Jhuggi)

Intervention Type OTHER

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'

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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'

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Megha Thakur

External PhD student at CAPHRI school of public health and primary care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Constant Paul Van Schayck, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, Caphri School of Public Health and Primary Care

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ashrayanagar slum

Bangalore, Karnataka, India

Site Status

Mathikere slum

Bangalore, , India

Site Status

Muneshwaranagar slum

Bangalore, , India

Site Status

Peenya slum

Bangalore, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28511647 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

076-00051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.