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: 1. Does LPG substitution or improved ventilation reduce HAP and improve cardiopulmonary health? 2. Would the combined intervention of LPG substitution and improved ventilation outperform single interventions? 3. What is the cost-effectiveness of such interventions, and are they sustainable? 4. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
Installation and use of kitchen ventilation facilities (e.g., range hood) during cooking to reduce indoor air pollution exposure.
Households are provided with liquefied gas stoves and encouraged to use liquefied gas instead of solid fuels for cooking.
Households continue using traditional solid fuels (e.g., coal or biomass) for cooking according to their usual practices.
Households continue cooking without installing additional ventilation facilities during the intervention period.
Suiping County Health Center
Zhumadian, Henan, China
NOT_YET_RECRUITINGHong'an County Health Center
Huanggang, Hubei, China
RECRUITINGLonghui County Health Center
Shaoyang, Hunan, China
NOT_YET_RECRUITINGChange in the Number of Ultrafine particles (UFP)
Unit: particles/cm³, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Measurement method: Monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of PM2.5
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.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG
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.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Forced Vital Capacity (FVC)
Forced Vital Capacity measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 Second measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Specific Chemical Components in Particulate Matter
Unit: ug/m3, Measuring instrument: Gilian (Sensidyne, USA), PEM-2-2.5 (MSP,USA), Measurement method: ICP-MS (Inductively Coupled Plasma Mass Spectrometry) and GC-MS/MS (Gas Chromatography-Tandem Mass Spectrometry).
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Ozone (O₃)
Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand), Measurement method: Monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Black Carbon (BC)
Unit: ug/m3, Measuring instrument: Model AE51 (AethLabs, USA), Measurement method: Monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Systolic and Diastolic Blood Pressure
Unit: mmHg, Instrument: Omron (Japan);
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Fractional Exhaled Nitric Oxide (FeNO)
Unit: ppb , Instrument: NIOX VERO (Aerocrine AB; Solna, Sweden);
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Pulse Wave Velocity (PWV)
Assessed using an arterial stiffness analyzer (Itamar Medical, Israel) to measure arterial stiffness in meters per second (m/s).
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Incidence of Obesity and Central Obesity
Obesity defined as body mass index (BMI) ≥28.0 kg/m²; central obesity defined as waist circumference ≥90 cm for men or ≥85 cm for women.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
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Incidence of Diabetes
Diagnostic criteria based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020). Defined as any of the following: fasting plasma glucose ≥7.0 mmol/L (confirmed by repeat testing), 2-h plasma glucose ≥11.1 mmol/L after a 75 g oral glucose tolerance test, HbA1c ≥6.5%, or random plasma glucose ≥11.1 mmol/L with typical hyperglycemic symptoms, or physician-diagnosed diabetes with initiation of glucose-lowering therapy during follow-up.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Incidence of Dyslipidemia
Diagnostic criteria based on the Chinese Guidelines for the Management of Dyslipidemia in Adults (2016). Defined as any of the following without lipid-lowering therapy: total cholesterol (TC) ≥6.2 mmol/L, triglycerides (TG) ≥2.3 mmol/L, low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, or high-density lipoprotein cholesterol (HDL-C) \<1.0 mmol/L, or physician-diagnosed dyslipidemia with initiation of lipid-lowering treatment during follow-up.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Incidence of Hypertension
Diagnostic criteria based on the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024). Defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg measured on three separate occasions without antihypertensive treatment, or physician-diagnosed hypertension with initiation of antihypertensive therapy during follow-up.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Incidence of Acute Exacerbation of Chronic Bronchitis
Measurement method: modified Anthonisen criteria. Participants with baseline chronic cough and sputum (≥3 months per year for ≥2 consecutive years) who develop acute worsening of ≥1 core symptom lasting ≥2 days (increased dyspnea, increased sputum volume, or purulent sputum) leading to activity limitation or additional medical treatment (e.g., antibiotics, oral corticosteroids, or clinical visit).
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Incidence of Acute Respiratory Infection
Measurement method: weekly electronic diary (eDiary/ePRO) recording new respiratory symptoms in the past 7 days, including onset time, body temperature, and symptom spectrum. Acute respiratory infection is defined as ≥2 respiratory symptoms. For eligible cases, an "infection event form" will be initiated to record healthcare utilization, testing, and medication. A new episode is defined as recurrence after ≥7 symptom-free days.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Forced Expiratory Flow at 75% of FVC (FEF75)
Forced Expiratory Flow at 75% of Forced Vital Capacity measured in Liters/Second. Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Forced Expiratory Flow at 50% of FVC (FEF50)
Forced Expiratory Flow at 50% of Forced Vital Capacity measured in Liters/Second. Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Forced Expiratory Flow at 25% of FVC (FEF25)
Forced Expiratory Flow at 25% of Forced Vital Capacity measured in Liters/Second. Method of Measurement: Standardized spirometric testing
Time frame: 1 year, with follow-ups at 6, 1 protocol.2, 24, and 36 months
Change in the Peak Expiratory Flow (PEF)
Peak Expiratory Flow measured using spirometer (HI105; Chestgraph, Japan).Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Cardio-Ankle Vascular Index (CAVI)
Measured using arterial stiffness analyzer (Itamar Medical, Israel) to assess arterial stiffness.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Peripheral Arterial Tone (PAT) Index
Assessed using the EndoPAT noninvasive endothelial function detection system (Itamar Medical, Israel).
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Environmental Noise Level
Unit: dB, Measuring instrument: Model ASV5910+ (Aihua Instruments Co., Ltd, China) , Measurement method: Monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Internal Exposure to PAHs and VOCs
Unit: ng/mL, Measuring samples: Urine samples, Measurement method: GC-MS/MS.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Internal Exposure to Metal Elements
Unit: ng/mL, Measuring samples: Blood and urine samples, Measurement method: ICP-MS.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Total Volatile Organic Compounds (TVOCs)
Unit: ug/m3, Measuring instrument: Model TG-503 (GrayWolf, USA), Measurement method: Monitoring device sensors
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of Nitrogen Dioxide (NO₂)
Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand) , Measurement method: Monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Concentrations of PM1 / PM10
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.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in Air Temperature
Unit: °C, Measuring instrument: HOBO temperature loggers, Measurement method: monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in Relative Humidity
Unit: %, Measuring instrument: HOBO humidity loggers, Measurement method: monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in Wind Speed
Unit: m/s, Measuring instrument: Portable ultrasonic anemometer (FT702LT/D-V22-FF, UK), Measurement method: monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in Wind Direction
Unit: degrees (°), Measuring instrument: Portable ultrasonic anemometer (FT702LT/D-V22-FF, UK), Measurement method: monitoring device sensors.
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Change in the Environmental Microbial Aerosols
Unit: copies/m³ or CFU/m³, Measuring instrument: Liquid-based bioaerosol samplers (BioSampler, SpinCon), Measurement method: Molecular biological detection (e.g., nucleic acid extraction and PCR-based analysis).
Time frame: 1 year, with follow-ups at 6, 12, 24, and 36 months