Cardiopulmonary Function, Environmental Exposures
Conditions
Brief summary
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.
Interventions
DEVICECooking ventilation facilities
Installation and use of kitchen ventilation facilities (e.g., range hood) during cooking to reduce indoor air pollution exposure.
BEHAVIORALUsing liquefied gas for cooking
Households are provided with liquefied gas stoves and encouraged to use liquefied gas instead of solid fuels for cooking.
BEHAVIORALUsing solid fuels for cooking
Households continue using traditional solid fuels (e.g., coal or biomass) for cooking according to their usual practices.
BEHAVIORALNo ventilation during cooking
Households continue cooking without installing additional ventilation facilities during the intervention period.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Ultrafine particles (UFP) | 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 | 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 | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Concentrations of Specific Chemical Components in Particulate Matter | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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). |
| Change in the Concentrations of Ozone (O₃) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand), Measurement method: Monitoring device sensors. |
| Change in the Concentrations of Black Carbon (BC) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ug/m3, Measuring instrument: Model AE51 (AethLabs, USA), Measurement method: Monitoring device sensors. |
| Change in the Systolic and Diastolic Blood Pressure | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: mmHg, Instrument: Omron (Japan); |
| Change in the Fractional Exhaled Nitric Oxide (FeNO) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ppb , Instrument: NIOX VERO (Aerocrine AB; Solna, Sweden); |
| Change in the Pulse Wave Velocity (PWV) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Assessed using an arterial stiffness analyzer (Itamar Medical, Israel) to measure arterial stiffness in meters per second (m/s). |
| Incidence of Obesity and Central Obesity | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| Incidence of Diabetes | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| Incidence of Dyslipidemia | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| Incidence of Hypertension | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| Incidence of Acute Exacerbation of Chronic Bronchitis | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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). |
| Incidence of Acute Respiratory Infection | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| Change in the Forced Expiratory Flow at 75% of FVC (FEF75) | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| Change in the Forced Expiratory Flow at 50% of FVC (FEF50) | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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. |
| 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 | Forced Expiratory Flow at 25% of Forced Vital Capacity measured in Liters/Second. Method of Measurement: Standardized spirometric testing |
| Change in the Peak Expiratory Flow (PEF) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Peak Expiratory Flow measured using spirometer (HI105; Chestgraph, Japan).Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol. |
| Change in the Cardio-Ankle Vascular Index (CAVI) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Measured using arterial stiffness analyzer (Itamar Medical, Israel) to assess arterial stiffness. |
| Change in the Peripheral Arterial Tone (PAT) Index | 1 year, with follow-ups at 6, 12, 24, and 36 months | Assessed using the EndoPAT noninvasive endothelial function detection system (Itamar Medical, Israel). |
| Change in the Environmental Noise Level | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: dB, Measuring instrument: Model ASV5910+ (Aihua Instruments Co., Ltd, China) , Measurement method: Monitoring device sensors. |
| Change in the Concentrations of Internal Exposure to PAHs and VOCs | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ng/mL, Measuring samples: Urine samples, Measurement method: GC-MS/MS. |
| Change in the Concentrations of Internal Exposure to Metal Elements | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ng/mL, Measuring samples: Blood and urine samples, Measurement method: ICP-MS. |
| Change in the Concentrations of Total Volatile Organic Compounds (TVOCs) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ug/m3, Measuring instrument: Model TG-503 (GrayWolf, USA), Measurement method: Monitoring device sensors |
| Change in the Concentrations of Nitrogen Dioxide (NO₂) | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand) , Measurement method: Monitoring device sensors. |
| Change in the Concentrations of PM1 / PM10 | 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 Air Temperature | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: °C, Measuring instrument: HOBO temperature loggers, Measurement method: monitoring device sensors. |
| Change in Relative Humidity | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: %, Measuring instrument: HOBO humidity loggers, Measurement method: monitoring device sensors. |
| Change in Wind Speed | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: m/s, Measuring instrument: Portable ultrasonic anemometer (FT702LT/D-V22-FF, UK), Measurement method: monitoring device sensors. |
| Change in Wind Direction | 1 year, with follow-ups at 6, 12, 24, and 36 months | Unit: degrees (°), Measuring instrument: Portable ultrasonic anemometer (FT702LT/D-V22-FF, UK), Measurement method: monitoring device sensors. |
| Change in the Environmental Microbial Aerosols | 1 year, with follow-ups at 6, 12, 24, and 36 months | 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). |
Countries
China
Contacts
CONTACTKuai Yu
CONTACTHao Wang
PRINCIPAL_INVESTIGATORKuai Yu
Huazhong University of Science and Technology
Outcome results
None listed