Clinical trial NCT05570552: 1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh
Official title: Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Air Pollution
mHealth Intervention
Cardiopulmonary Function
Immune Function
Keywords: Mobile based Behavioral Change Communication intervention
Household air pollution reduction
Cardiopulmonary function
Immune function
Clean fuel LPG
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Mailman School of Public Health
name: Marquette University
First posted: 2022-10-06
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

1. 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-
2. subclinical measures of cardio-vascular and pulmonary dysfunction.
3. balanced changes in innate/ inflammatory and adaptive immune function (vaccine response).

Objectives: To evaluate

1. The effects of a scalable educational intervention (using mHealth application) on adoption and exclusive use of LPG.
2. The long-term effects of HAP reduction on subclinical measures of cardio-vascular and pulmonary dysfunction.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Personal air pollution
timeFrame: Pre-intervention
measure: Personal air pollution
timeFrame: Two-year post intervention
measure: Ambient air pollution
timeFrame: Pre-intervention
measure: Ambient air pollution
timeFrame: Two-year post intervention
measure: Lung function assessment by spirometry
timeFrame: Pre-intervention
measure: Lung function assessment by spirometry
timeFrame: Two-year post intervention
measure: Assessment lung pathology by chest X-ray and High-resolution Computed tomography
timeFrame: Pre-intervention
measure: Assessment lung pathology by chest X-ray and High-resolution Computed tomography
timeFrame: Two-year post intervention
measure: Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
timeFrame: Pre-intervention
measure: Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
timeFrame: Two-year post intervention
measure: Measurement of cardiovascular disease (CVD) markers by performing EKG
timeFrame: Pre-intervention
measure: Measurement of cardiovascular disease (CVD) markers by performing EKG
timeFrame: Two-year post intervention
measure: Evaluation of metabolic markers (diabetes) in blood at baseline.
timeFrame: Pre-intervention
measure: Evaluation of metabolic markers (diabetes) in blood after intervention.
timeFrame: Two-year post intervention
measure: Evaluation of metabolic markers (CVD) in blood.
timeFrame: Pre-intervention
measure: Evaluation of metabolic markers (CVD) in blood.
timeFrame: Two-year post intervention
measure: Assessment of immune function in blood cells
timeFrame: Pre-intervention
measure: Assessment of immune function in blood cells
timeFrame: Two-year post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Diseases Research, Bangladesh
Study officials:
References: