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

Immune Function Clinical Trial

— GEOHealth-II  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570552
• Other study ID #: PR-22057 (2U01TW010120-06)
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: Rubhana Raqib, PhD
• Phone: +8802222277001-10
• Email: rubhana[@]icddrb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Air Pollution
• Cardiopulmonary Function
• Immune Function
• mHealth Intervention

Intervention

Behavioral:
• mHealth based behavioral change communication intervention
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.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Diseases Research, Bangladesh	Dhaka

Sponsors (4)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Mailman School of Public Health, Marquette University, University of Chicago

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal air pollution	Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device	Pre-intervention
Primary	Personal air pollution	Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device	Two-year post intervention
Primary	Ambient air pollution	Measurement of ambient air pollution (PM2.5) by ambient air monitoring device	Pre-intervention
Primary	Ambient air pollution	Measurement of ambient air pollution (PM2.5) by ambient air monitoring device	Two-year post intervention
Primary	Lung function assessment by spirometry	Lung function assessment by spirometry	Pre-intervention
Primary	Lung function assessment by spirometry	Lung function assessment by spirometry	Two-year post intervention
Primary	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
Primary	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
Primary	Measurement of cardiovascular disease (CVD) markers by measuring blood pressure	Preclinical markers of CVD assessment by blood pressure	Pre-intervention
Primary	Measurement of cardiovascular disease (CVD) markers by measuring blood pressure	Preclinical markers of CVD assessment by blood pressure	Two-year post intervention
Primary	Measurement of cardiovascular disease (CVD) markers by performing EKG	Preclinical markers of CVD assessment by EKG	Pre-intervention
Primary	Measurement of cardiovascular disease (CVD) markers by performing EKG	Preclinical markers of CVD assessment by EKG	Two-year post intervention
Primary	Evaluation of metabolic markers (diabetes) in blood at baseline.	Assessment of metabolic dysfunction by measuring HbA1c	Pre-intervention
Primary	Evaluation of metabolic markers (diabetes) in blood after intervention.	Assessment of metabolic dysfunction by measuring HbA1c	Two-year post intervention
Primary	Evaluation of metabolic markers (CVD) in blood.	Assessment of metabolic dysfunction by measuring fasting lipid profile.	Pre-intervention
Primary	Evaluation of metabolic markers (CVD) in blood.	Assessment of metabolic dysfunction by measuring fasting lipid profile.	Two-year post intervention
Primary	Assessment of immune function in blood cells	Immune function will be assessed by phenotyping using flowcytometry	Pre-intervention
Primary	Assessment of immune function in blood cells	Immune function will be assessed by phenotyping using flowcytometry	Two-year post intervention