Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Measurement of cardiovascular disease (CVD) markers by performing EKG
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Measurement of cardiovascular disease (CVD) markers by performing EKG
时间窗: Two-year post intervention
Preclinical markers of CVD assessment by EKG
Assessment of immune function in blood cells
时间窗: Two-year post intervention
Immune function will be assessed by phenotyping using flowcytometry
Ambient air pollution
时间窗: Two-year post intervention
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
时间窗: Two-year post intervention
Preclinical markers of CVD assessment by blood pressure
Personal air pollution
时间窗: Two-year post intervention
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Evaluation of metabolic markers (diabetes) in blood at baseline.
时间窗: Pre-intervention
Assessment of metabolic dysfunction by measuring HbA1c
Evaluation of metabolic markers (CVD) in blood.
时间窗: Two-year post intervention
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Lung function assessment by spirometry
时间窗: Two-year post intervention
Lung function assessment by spirometry
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
时间窗: 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.
Evaluation of metabolic markers (diabetes) in blood after intervention.
时间窗: Two-year post intervention
Assessment of metabolic dysfunction by measuring HbA1c
次要结局
未报告次要终点
