1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh

Study Overview
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Brief Summary
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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.

Detailed Description
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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). Exploratory (Pilot) studies: the investigators aim to investigate health hazards of industrial wastes including polyaromatic hydrocarbon (PAH), polychlorinated dibenzodioxins (PCDDs) etc. occupational health risks (lung health) of readymade garment industry workers, especially among young women's health. 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.

Official Title
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Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial

Conditions
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Air Pollution, mHealth Intervention, Cardiopulmonary Function, Immune Function

Intervention / Treatment
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* Behavioral: mHealth based behavioral change communication intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in the previous GEOHEALTH round-I study Aged between 30 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth arm<br>mHealth arm will receive mobile phone based behavior change communication intervention to exclusively use clean fuel LPG for domestic cooking. | Behavioral: mHealth based behavioral change communication intervention<br>* 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.<br>* Other names: value sensitive design (VSD), Fogg Behavior Model (FBM), System Usability Scale (SUS);|
| No Intervention: Control arm<br>Control arm will receive no mHealth based intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile based Behavioral Change Communication intervention, Household air pollution reduction, Cardiopulmonary function, Immune function, Clean fuel LPG