1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh
GEOHealth-II
Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial
1 other identifier
interventional
1,000
1 country
1
Brief Summary
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use, especially in low- and middle-income countries (LMICs). Earlier the investigators showed that Liquid Petroleum Gas (LPG) for 24 months, reduced personal PM2.5 exposure by 58.17 percent which induced novel changes in immune and inflammatory responses in the participants; however cardiopulmonary markers remained relatively stable in post-intervention assessment. In this study, the investigators aim to evaluate the effects of mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention on adoption and exclusive use of LPG. The investigators also aimed to observe whether long-term effects of HAP reduction can impact the subclinical measures of cardio-vascular and pulmonary dysfunction and regulate innate and inflammatory immune function among women and children in semi-rural settings in Bangladesh. The investigators will also investigate the influence of exposure to HAP on antibody response to vaccines (adaptive immunity). The BCC intervention will be provided by conducting a large household level randomized controlled trial by educational intervention using mHealth based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 22, 2024
March 1, 2024
3.9 years
August 29, 2022
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Personal air pollution
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Pre-intervention
Personal air pollution
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Two-year post intervention
Ambient air pollution
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Pre-intervention
Ambient air pollution
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Two-year post intervention
Lung function assessment by spirometry
Lung function assessment by spirometry
Pre-intervention
Lung function assessment by spirometry
Lung function assessment by spirometry
Two-year post intervention
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Lung pathology will be assessed by chest X-ray for all participants and high-resolution Computed tomography of the chest (HRCT) will be performed in selected participants.
Pre-intervention
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Lung pathology will be assessed by chest X-ray for all participants and high-resolution Computed tomography of the chest (HRCT) will be performed in selected participants.
Two-year post intervention
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Preclinical markers of CVD assessment by blood pressure
Pre-intervention
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Preclinical markers of CVD assessment by blood pressure
Two-year post intervention
Measurement of cardiovascular disease (CVD) markers by performing EKG
Preclinical markers of CVD assessment by EKG
Pre-intervention
Measurement of cardiovascular disease (CVD) markers by performing EKG
Preclinical markers of CVD assessment by EKG
Two-year post intervention
Evaluation of metabolic markers (diabetes) in blood at baseline.
Assessment of metabolic dysfunction by measuring HbA1c
Pre-intervention
Evaluation of metabolic markers (diabetes) in blood after intervention.
Assessment of metabolic dysfunction by measuring HbA1c
Two-year post intervention
Evaluation of metabolic markers (CVD) in blood.
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Pre-intervention
Evaluation of metabolic markers (CVD) in blood.
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Two-year post intervention
Assessment of immune function in blood cells
Immune function will be assessed by phenotyping using flowcytometry
Pre-intervention
Assessment of immune function in blood cells
Immune function will be assessed by phenotyping using flowcytometry
Two-year post intervention
Study Arms (2)
mHealth arm
EXPERIMENTALmHealth arm will receive mobile phone based behavior change communication intervention to exclusively use clean fuel LPG for domestic cooking.
Control arm
NO INTERVENTIONControl arm will receive no mHealth based intervention.
Interventions
We will implement a mHealth based communication system. The number of text messages and push notifications that a participant receives, will be variable and will occur at least weekly (based upon their responses) or the participant opts out of receiving messages. Participant change of behavior and use of improved stoves will be monitored by tracking clicks/views of educational materials and video vignettes.
Eligibility Criteria
You may qualify if:
- Participants in the previous GEOHEALTH round-I study
- Aged between 25 and 70 years
- Live in biomass-using home with traditional stoves
- Non-smoker and live with non-smokers
- Exposed to \<10 µg/L of water arsenic
You may not qualify if:
- Known to have immune related illness or taking any prescription medication (particularly those that suppress or enhance immune function)
- Known to have any clinical events of CVD or lung disease, including stroke or coronary heart disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladeshlead
- University of Chicagocollaborator
- Mailman School of Public Healthcollaborator
- Marquette Universitycollaborator
Study Sites (1)
International Centre for Diarrhoeal Diseases Research, Bangladesh
Dhaka, 1212, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2022
First Posted
October 6, 2022
Study Start
June 20, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 22, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available 6 months after manuscripts accepted for publication
All data collected of the proposed study will be made fully available to any bonafide researcher. In general, the investigators will follow the data sharing plan developed and practiced by the NIH-funded grantees. Any data request by external researchers will be reviewed by the PIs and the AOC and the requested specific data will be made available to the through a secured web-based interface developed specifically for this project. In general, data will be made available six months after the manuscript reporting results from those specific sets of data are accepted for publication and all data requests will be processed within six months from the receipt of the request in writing. Any data requests with potential conflicts will be reviewed and decided by the AOC.