NCT02821650

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

June 21, 2016

Last Update Submit

March 9, 2021

Conditions

Signs and Symptoms, RespiratoryAir Pollution, Indoor

Outcome Measures

Primary Outcomes (2)

  • Lung function

    Measure change in lung function (FEV1/FVC) as measured by spirometry in the primary cook

    1 year

  • 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

    1 year

Secondary Outcomes (3)

  • PM2.5 and CO exposure

    1 year

  • Respiratory symptoms

    1 year

  • Other related symptoms

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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)

control

NO INTERVENTION

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

Interventions

TEJ (Traditional stove to Efficient stove in Jhuggi)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'

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Households with a cooking area outside the house will be excluded
  • Persons who are seriously ill will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ashrayanagar slum

Bangalore, Karnataka, 560058, India

Location

Mathikere slum

Bangalore, India

Location

Muneshwaranagar slum

Bangalore, India

Location

Peenya slum

Bangalore, India

Location

Related Publications (1)

  • 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.

    PMID: 28511647DERIVED

Related Links

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Constant Paul Van Schayck, PhD

    Maastricht University, Caphri School of Public Health and Primary Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
External PhD student at CAPHRI school of public health and primary care

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 1, 2016

Study Start

April 19, 2017

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(4)