- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05570552
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass fuel (wood, agricultural residue, cow dung, etc.) used 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 such as Liquid Petroleum Gas, especially in low- and middle-income countries (LMICs).
Rationale: In the earlier GEOHealth (Round-I) study, the investigators have shown that LPG for 24 months, reduced personal PM2.5 exposure by 58.2 percent which induced novel changes in innate immune and inflammatory responses in women but the changes in chronic cardio-pulmonary markers were not prominent, most likely due to short duration of follow up and probably impact of ambient pollution. Moreover, sustained use of LPG could be challenging as earlier GEOHealth (Round-I) study provided the cook stove and supply of LPG free of cost. A post-completion screening showed >70% households continued using LPG albeit not exclusively. It is plausible that an intervention using mobile phone-based application can improve the exclusive use of LPG in the communities.
Hypothesis:
The mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention can be easily incorporated in Government policy that can promote adoption, and increase exclusive use of LPG in the communities.
The long-term effect of HAP reduction can be associated with-
- subclinical measures of cardio-vascular and pulmonary dysfunction.
- balanced changes in innate/ inflammatory and adaptive immune function (vaccine response).
Objectives: To evaluate
- The effects of a scalable educational intervention (using mHealth application) on adoption and exclusive use of LPG.
- The long-term effects of HAP reduction on subclinical measures of cardio-vascular and pulmonary dysfunction.
- The long-term effects of HAP reduction on innate/ inflammatory immune function among women and children and to investigate the influence of HAP exposure on antibody response to vaccines (adaptive immunity).
Methods: The investigators will conduct a large household level randomized controlled trial by educational intervention using mobile phone (mHealth) based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area-wise (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.
Outcome measures/variables: Personal and surrounding area PM2.5 and BC level will be measured at pre- and post-intervention. Lung function and lung pathology will be assessed through spirometry, Chest X-ray, and High-resolution Computed tomography of the chest (HRCT). Preclinical makers of cardiovascular diseases (CVD) will include blood pressure and EKG. Markers of metabolic dysfunction will be assesses by measuring HbA1c and fasting lipid profile. Immune function will be assessed by phenotyping of Immune cells, functional cytotoxic killer cells, oxidative stress of lymphocytes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rubhana Raqib, PhD
- Phone Number: 2404 +8802222277001-10
- Email: rubhana@icddrb.org
Study Contact Backup
- Name: Mohammad Yunus, MBBS, M.Sc.
- Phone Number: 2210 +8802222277001-10
- Email: myunus@icddrb.org
Study Locations
-
-
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Dhaka, Bangladesh, 1212
- Recruiting
- International Centre for Diarrhoeal Diseases Research, Bangladesh
-
Contact:
- Rubhana Raqib, PhD
- Phone Number: 2404 +8802222277001-10
- Email: rubhana@icddrb.org
-
Principal Investigator:
- Rubhana Raqib, PhD
-
Sub-Investigator:
- Mohammad Yunus, M.Sc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mHealth arm
mHealth arm will receive mobile phone based behavior change communication intervention to exclusively use clean fuel LPG for domestic cooking.
|
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.
Other Names:
|
No Intervention: Control arm
Control arm will receive no mHealth based intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal air pollution
Time Frame: Pre-intervention
|
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
|
Pre-intervention
|
Personal air pollution
Time Frame: Two-year post intervention
|
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
|
Two-year post intervention
|
Ambient air pollution
Time Frame: Pre-intervention
|
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
|
Pre-intervention
|
Ambient air pollution
Time Frame: Two-year post intervention
|
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
|
Two-year post intervention
|
Lung function assessment by spirometry
Time Frame: Pre-intervention
|
Lung function assessment by spirometry
|
Pre-intervention
|
Lung function assessment by spirometry
Time Frame: Two-year post intervention
|
Lung function assessment by spirometry
|
Two-year post intervention
|
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Time Frame: Pre-intervention
|
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
Time Frame: Two-year post intervention
|
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
Time Frame: Pre-intervention
|
Preclinical markers of CVD assessment by blood pressure
|
Pre-intervention
|
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Time Frame: Two-year post intervention
|
Preclinical markers of CVD assessment by blood pressure
|
Two-year post intervention
|
Measurement of cardiovascular disease (CVD) markers by performing EKG
Time Frame: Pre-intervention
|
Preclinical markers of CVD assessment by EKG
|
Pre-intervention
|
Measurement of cardiovascular disease (CVD) markers by performing EKG
Time Frame: Two-year post intervention
|
Preclinical markers of CVD assessment by EKG
|
Two-year post intervention
|
Evaluation of metabolic markers (diabetes) in blood at baseline.
Time Frame: Pre-intervention
|
Assessment of metabolic dysfunction by measuring HbA1c
|
Pre-intervention
|
Evaluation of metabolic markers (diabetes) in blood after intervention.
Time Frame: Two-year post intervention
|
Assessment of metabolic dysfunction by measuring HbA1c
|
Two-year post intervention
|
Evaluation of metabolic markers (CVD) in blood.
Time Frame: Pre-intervention
|
Assessment of metabolic dysfunction by measuring fasting lipid profile.
|
Pre-intervention
|
Evaluation of metabolic markers (CVD) in blood.
Time Frame: Two-year post intervention
|
Assessment of metabolic dysfunction by measuring fasting lipid profile.
|
Two-year post intervention
|
Assessment of immune function in blood cells
Time Frame: Pre-intervention
|
Immune function will be assessed by phenotyping using flowcytometry
|
Pre-intervention
|
Assessment of immune function in blood cells
Time Frame: Two-year post intervention
|
Immune function will be assessed by phenotyping using flowcytometry
|
Two-year post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health hazards of industrial waste - a pilot study
Time Frame: In one year
|
Health hazards of industrial waste reflected by measurement of polycyclic aromatic hydrocarbons, polychlorinated dibenzodioxins and dibenzofurans in adjacent water bodies
|
In one year
|
Occupational health hazard among garments/textile factory workers - a pilot study
Time Frame: In one year
|
Prevalence of lung function abnormalities among garments/textile mills/power loom factory workers through structured questionnaire based data collection and spirometry.
|
In one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PR-22057 (2U01TW010120-06)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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