Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02821650 |
| Other study ID # |
076-00051 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 19, 2017 |
| Est. completion date |
March 10, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Maastricht University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
