NCT Number: NCT05570552
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.
Interested in participating?
Request Info25 year–70 year
Female
Interventional
Not applicable
Dhaka, 1212, Bangladesh
Location status: Recruiting
Mohammad Yunus, M.Sc
SUB_INVESTIGATOR
Rubhana Raqib, PhD
CONTACT
+8802222277001-10 ext. 2404
Rubhana Raqib, PhD
PRINCIPAL_INVESTIGATOR
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 long-term effect of HAP reduction can be associated with-
Objectives: To evaluate
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: value sensitive design (VSD), Fogg Behavior Model (FBM), System Usability Scale (SUS)
Time frame: Pre-intervention
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Time frame: Two-year post intervention
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Time frame: Pre-intervention
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Time frame: Two-year post intervention
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Time frame: Pre-intervention
Lung function assessment by spirometry
Time frame: Two-year post intervention
Lung function assessment by spirometry
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.
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.
Time frame: Pre-intervention
Preclinical markers of CVD assessment by blood pressure
Time frame: Two-year post intervention
Preclinical markers of CVD assessment by blood pressure
Time frame: Pre-intervention
Preclinical markers of CVD assessment by EKG
Time frame: Two-year post intervention
Preclinical markers of CVD assessment by EKG
Time frame: Pre-intervention
Assessment of metabolic dysfunction by measuring HbA1c
Time frame: Two-year post intervention
Assessment of metabolic dysfunction by measuring HbA1c
Time frame: Pre-intervention
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Time frame: Two-year post intervention
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Time frame: Pre-intervention
Immune function will be assessed by phenotyping using flowcytometry
Time frame: Two-year post intervention
Immune function will be assessed by phenotyping using flowcytometry
Contact information is provided by the study sponsor or research team.
Mohammad Yunus, MBBS, M.Sc.
CONTACT
+8802222277001-10 ext. 2210
Rubhana Raqib, PhD
CONTACT
+8802222277001-10 ext. 2404
International Centre for Diarrhoeal Disease Research, Bangladesh
Other
Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial
Acronym: GEOHealth-II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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