Effects of LPG and Ventilation Interventions on Reducing HAP and Improving Cardiopulmonary Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Cooking ventilation facilities

    Device

    Installation and use of kitchen ventilation facilities (e.g., range hood) during cooking to reduce indoor air pollution exposure.

  • Using liquefied gas for cooking

    Behavioral

    Households are provided with liquefied gas stoves and encouraged to use liquefied gas instead of solid fuels for cooking.

  • Using solid fuels for cooking

    Behavioral

    Households continue using traditional solid fuels (e.g., coal or biomass) for cooking according to their usual practices.

  • No ventilation during cooking

    Behavioral

    Households continue cooking without installing additional ventilation facilities during the intervention period.

Treatment groups

1,200 Participants
are divided into 4 treatment groups
Group A: A: Solid fuel + no ventilation (control).Other 2 interventions
Group B: B: LPG + no ventilation.Experimental treatment 2 interventions
Group C: C: Solid fuel + ventilation.Experimental treatment 2 interventions
Group D: D: LPG + ventilation.Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change 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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Change in the Serum Levels of Myocardial Function Biomarkers (BNP, NT-proBNP, Follistatin, Myoglobin, CK-MB, Troponin I, Troponin T)

Units (e.g., pg/mL or ng/mL) depend on the specific analyte and assay standard. Serum concentrations of the following myocardial function biomarkers will be measured: B-type Natriuretic Peptide (BNP), N-terminal prohormone BNP (NT-proBNP) , Follistatin, Myoglobin, Creatine Kinase-MB (CK-MB), Troponin I, Troponin T, Method: MILLIPLEX: serum;

Time frame
1 year, with follow-ups at 6, 12, 24, and 36 months
2

Change in the Serum Levels of Club Cell Protein 16 (CC16) and Surfactant Protein D (SP-D)

Lung epithelial injury will be assessed by measuring serum levels of:Club Cell Protein 16 (CC16), Surfactant Protein D (SP-D). Method: enzyme-linked immunosorbent assay (ELISA) in serum samples. Units are typically pg/mL or ng/mL, depending on assay specifications.

Time frame
1 year, with follow-ups at 6, 12, 24, and 36 months
3

Change in the Serum Levels of Blood Glucose, Insulin, and C-Peptide

Method: glucose oxidase method: serum. Units (e.g., mmol/L for glucose, μIU/mL or pmol/L for insulin and C-peptide) depend on assay specifications

Time frame
1 year, with follow-ups at 6, 12, 24, and 36 months
4

Change in the Genome-wide DNA Methylation Levels in Blood Samples

Epigenetic alterations will be assessed by measuring genome-wide DNA methylation levels using peripheral blood-derived DNA.

Time frame
1 year, with follow-ups at 6, 12, 24, and 36 months

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