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临床试验/NCT05570552
NCT05570552招募中不适用

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

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年6月20日最近更新:
适应症

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:

  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.

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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