Effects of Liquefied Petroleum Gas and Ventilation Interventions on Reducing Household Air Pollution From Solid Fuel Use and Improving Cardiopulmonary Health: A Multi-center, 2×2 Factorial Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Change in the Number of Ultrafine particles (UFP)
研究概览
简要总结
The goal of this clinical trial is to evaluate the independent and synergistic effects of liquefied petroleum gas (LPG) substitution and improved ventilation on household air pollution (HAP) reduction and cardiopulmonary health. The main questions it aims to answer are:
- Does LPG substitution or improved ventilation reduce HAP and improve cardiopulmonary health?
- Would the combined intervention of LPG substitution and improved ventilation outperform single interventions?
- What is the cost-effectiveness of such interventions, and are they sustainable?
- Does the intervention reduce the incidence of cardiopulmonary clinical events?
Participants will be randomized in 4 groups:
A: Solid fuel + no ventilation facilities group (300 households): Continued use of solid fuels without installation of ventilation facilities and receipt of standardized health education. No LPG stoves or ventilation equipment will be provided during the intervention period. However, after the primary endpoint assessment at 12 months, all households in Group A will be provided with LPG stoves and ventilation facilities of equivalent specifications free of charge, along with health guidance. Phased cash compensation will be provided during the intervention period.
B: Liquefied petroleum gas (LPG) + no ventilation facilities group (300 households): Provided with LPG stoves and instructed to use them during cooking, with regular LPG supply throughout the intervention period. Participants will also receive standardized health education.
C: Solid fuel + ventilation facilities group (300 households): Continued use of solid fuels while being provided with ventilation facilities and instructed to use them during cooking. Electricity costs will be compensated during the intervention period. Participants will also receive standardized health education.
D: LPG + ventilation facilities group (300 households): Provided with both LPG stoves and ventilation facilities and instructed to use both during cooking. Regular LPG supply and electricity cost compensation will be provided throughout the intervention period. Participants will also receive standardized health education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria Primary Participants：
- •Aged 18-75 years;
- •Local permanent residents with no plans for long-term travel or relocation within one year;
- •Kitchen suitable for installation of ventilation facilities;
- •Responsible for daily household cooking, cooking ≥5 times per week;
- •To control for community penetration of pollution, households will be preferentially recruited in naturally ventilated, open villages, avoiding valleys or basins that hinder pollutant dispersion; preference for detached houses with ≥10 m distance from neighboring kitchens and well-sealed doors and windows.
- •Secondary Participants:
- •Elderly individuals aged 65-75 living with the primary participant;
- •Children aged 3-6 living in the same household.
排除标准
- •Clinical diagnosis of major chronic diseases such as severe respiratory diseases, cardiovascular diseases, malignant tumors, or end-stage renal disease;
- •Pregnant or breastfeeding women;
- •Current smokers or individuals with self-reported exposure to productive dust or other occupational hazards;
- •Individuals who are unable to fully understand the study process or clearly express their own complaints, such as those with psychiatric disorders or severe neuroses, or who cannot cooperate with the study for other reasons.
研究组 & 干预措施
B: LPG + no ventilation.
Liquefied petroleum gas (LPG) + no ventilation facilities group: Provided with LPG stoves and instructed to use them during cooking, with regular LPG supply throughout the intervention period. Participants will also receive standardized health education.
干预措施: Using liquefied gas for cooking (Behavioral)
D: LPG + ventilation.
LPG + ventilation facilities group: Provided with both LPG stoves and ventilation facilities and instructed to use both during cooking. Regular LPG supply and electricity cost compensation will be provided throughout the intervention period. Participants will also receive standardized health education.
干预措施: Using liquefied gas for cooking (Behavioral)
A: Solid fuel + no ventilation (control).
Solid fuel + no ventilation facilities group: Continued use of solid fuels without installation of ventilation facilities and receipt of standardized health education. No LPG stoves or ventilation equipment will be provided during the intervention period. However, after the primary endpoint assessment at 12 months, all households in Group A will be provided with LPG stoves and ventilation facilities of equivalent specifications free of charge, along with health guidance. Phased cash compensation will be provided during the intervention period.
干预措施: Using solid fuels for cooking (Behavioral)
A: Solid fuel + no ventilation (control).
Solid fuel + no ventilation facilities group: Continued use of solid fuels without installation of ventilation facilities and receipt of standardized health education. No LPG stoves or ventilation equipment will be provided during the intervention period. However, after the primary endpoint assessment at 12 months, all households in Group A will be provided with LPG stoves and ventilation facilities of equivalent specifications free of charge, along with health guidance. Phased cash compensation will be provided during the intervention period.
干预措施: No ventilation during cooking (Behavioral)
B: LPG + no ventilation.
Liquefied petroleum gas (LPG) + no ventilation facilities group: Provided with LPG stoves and instructed to use them during cooking, with regular LPG supply throughout the intervention period. Participants will also receive standardized health education.
干预措施: No ventilation during cooking (Behavioral)
C: Solid fuel + ventilation.
Solid fuel + ventilation facilities group: Continued use of solid fuels while being provided with ventilation facilities and instructed to use them during cooking. Electricity costs will be compensated during the intervention period. Participants will also receive standardized health education.
干预措施: Cooking ventilation facilities (Device)
C: Solid fuel + ventilation.
Solid fuel + ventilation facilities group: Continued use of solid fuels while being provided with ventilation facilities and instructed to use them during cooking. Electricity costs will be compensated during the intervention period. Participants will also receive standardized health education.
干预措施: Using solid fuels for cooking (Behavioral)
D: LPG + ventilation.
LPG + ventilation facilities group: Provided with both LPG stoves and ventilation facilities and instructed to use both during cooking. Regular LPG supply and electricity cost compensation will be provided throughout the intervention period. Participants will also receive standardized health education.
干预措施: Cooking ventilation facilities (Device)
结局指标
主要结局
Change in the Number of Ultrafine particles (UFP)
时间窗: 1 year, with follow-ups at 6, 12, 24, and 36 months
Unit: particles/cm³, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Measurement method: Monitoring device sensors.
Change in the Concentrations of PM2.5
时间窗: 1 year, with follow-ups at 6, 12, 24, and 36 months
Unit: ug/m3, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Bbair (Yuanrui Environmental Protection Technology Co., Ltd, China) , Measurement method: Monitoring device sensors.
Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG
时间窗: 1 year, with follow-ups at 6, 12, 24, and 36 months
Heart rate variability measured using standard 12-lead electrocardiogram (ECG). Measuring instrument: HeaLink heart rate sensor (Henan Link Medical Technology Co., Ltd., China), The time-domain indicators include:SDNN: Standard deviation of all normal-to-normal (NN) intervals over 24 hours / SDANN: Standard deviation of the average NN intervals calculated over 5-minute segments throughout 24 hours / RMSSD: Root mean square of successive differences between adjacent NN intervals over 24 hours. The frequency-domain indicators include: TP: Total power / LF: Low-frequency power / HF: High-frequency power / LF/HF: Ratio of low-frequency to high-frequency power.
Change in the Forced Vital Capacity (FVC)
时间窗: 1 year, with follow-ups at 6, 12, 24, and 36 months
Forced Vital Capacity measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol.
Change in the Forced Expiratory Volume in 1 Second (FEV1)
时间窗: 1 year, with follow-ups at 6, 12, 24, and 36 months
Forced Expiratory Volume in 1 Second measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol.
次要结局
- Change in the Concentrations of PM1 / PM10(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Specific Chemical Components in Particulate Matter(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Ozone (O₃)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Black Carbon (BC)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Systolic and Diastolic Blood Pressure(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Fractional Exhaled Nitric Oxide (FeNO)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Pulse Wave Velocity (PWV)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Forced Expiratory Flow at 75% of FVC (FEF75)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Forced Expiratory Flow at 50% of FVC (FEF50)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Forced Expiratory Flow at 25% of FVC (FEF25)(1 year, with follow-ups at 6, 1 protocol.2, 24, and 36 months)
- Change in the Peak Expiratory Flow (PEF)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Cardio-Ankle Vascular Index (CAVI)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Peripheral Arterial Tone (PAT) Index(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Environmental Noise Level(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Internal Exposure to PAHs and VOCs(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Internal Exposure to Metal Elements(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Total Volatile Organic Compounds (TVOCs)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Concentrations of Nitrogen Dioxide (NO₂)(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Incidence of Obesity and Central Obesity(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Incidence of Diabetes(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Incidence of Dyslipidemia(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Incidence of Hypertension(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in Wind Direction(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Incidence of Acute Exacerbation of Chronic Bronchitis(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Incidence of Acute Respiratory Infection(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in Air Temperature(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in Relative Humidity(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in Wind Speed(1 year, with follow-ups at 6, 12, 24, and 36 months)
- Change in the Environmental Microbial Aerosols(1 year, with follow-ups at 6, 12, 24, and 36 months)
研究者
Kuai Yu
Associate Research Fellow, Principal Investigator
Huazhong University of Science and Technology