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NCT Number: NCT07005193

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

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.

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Key information

Conditions

Cardiopulmonary Function Environmental Exposures

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suiping County Health Center, Zhumadian, Henan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in the Number of Ultrafine particles (UFP)

    Time frame: 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.

  2. Change in the Concentrations of PM2.5

    Time frame: 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.

  3. Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG

    Time frame: 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.

  4. Change in the Forced Vital Capacity (FVC)

    Time frame: 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.

  5. Change in the Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: 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 outcomes

  1. Change in the Concentrations of Specific Chemical Components in Particulate Matter

    Time frame: 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).

  2. Change in the Concentrations of Ozone (O₃)

    Time frame: 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.

  3. Change in the Concentrations of Black Carbon (BC)

    Time frame: 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.

  4. Change in the Systolic and Diastolic Blood Pressure

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

    Unit: mmHg, Instrument: Omron (Japan);

  5. Change in the Fractional Exhaled Nitric Oxide (FeNO)

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

    Unit: ppb , Instrument: NIOX VERO (Aerocrine AB; Solna, Sweden);

  6. Change in the Pulse Wave Velocity (PWV)

    Time frame: 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).

  7. Incidence of Obesity and Central Obesity

    Time frame: 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.

  8. Incidence of Diabetes

    Time frame: 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.

  9. Incidence of Dyslipidemia

    Time frame: 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.

  10. Incidence of Hypertension

    Time frame: 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.

  11. Incidence of Acute Exacerbation of Chronic Bronchitis

    Time frame: 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).

  12. Incidence of Acute Respiratory Infection

    Time frame: 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.

  13. Change in the Forced Expiratory Flow at 75% of FVC (FEF75)

    Time frame: 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.

  14. Change in the Forced Expiratory Flow at 50% of FVC (FEF50)

    Time frame: 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.

  15. Change in the Forced Expiratory Flow at 25% of FVC (FEF25)

    Time frame: 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

  16. Change in the Peak Expiratory Flow (PEF)

    Time frame: 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.

  17. Change in the Cardio-Ankle Vascular Index (CAVI)

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

    Measured using arterial stiffness analyzer (Itamar Medical, Israel) to assess arterial stiffness.

  18. Change in the Peripheral Arterial Tone (PAT) Index

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

    Assessed using the EndoPAT noninvasive endothelial function detection system (Itamar Medical, Israel).

  19. Change in the Environmental Noise Level

    Time frame: 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.

  20. Change in the Concentrations of Internal Exposure to PAHs and VOCs

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

    Unit: ng/mL, Measuring samples: Urine samples, Measurement method: GC-MS/MS.

  21. Change in the Concentrations of Internal Exposure to Metal Elements

    Time frame: 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.

  22. Change in the Concentrations of Total Volatile Organic Compounds (TVOCs)

    Time frame: 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

  23. Change in the Concentrations of Nitrogen Dioxide (NO₂)

    Time frame: 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.

  24. Change in the Concentrations of PM1 / PM10

    Time frame: 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.

  25. Change in Air Temperature

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

    Unit: °C, Measuring instrument: HOBO temperature loggers, Measurement method: monitoring device sensors.

  26. Change in Relative Humidity

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

    Unit: %, Measuring instrument: HOBO humidity loggers, Measurement method: monitoring device sensors.

  27. Change in Wind Speed

    Time frame: 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.

  28. Change in Wind Direction

    Time frame: 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.

  29. Change in the Environmental Microbial Aerosols

    Time frame: 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).

Other outcomes

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

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

    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;

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

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

    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.

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

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

    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

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

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

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

  5. Change in the Serum Levels of Oxidative Stress Biomarkers

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

    Oxidative stress status will be assessed by measuring serum concentrations of the following biomarkers using ELISA assays: Angiotensin II (Ang-II) / NADPH oxidase (NOX) / Superoxide dismutase (SOD) / Glutathione (GSH) / Malondialdehyde (MDA) / Oxidized low-density lipoprotein (ox-LDL).

  6. Change in the Serum Levels of HPA Axis Stress Hormones (Cortisol, ACTH, CRH)

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

    The hypothalamic-pituitary-adrenal (HPA) axis function will be evaluated by measuring serum concentrations of: Cortisol / Adrenocorticotropic hormone (ACTH) / Corticotropin-releasing hormone (CRH). Measurements will be performed using enzyme-linked immunosorbent assay (ELISA).

  7. Change in the Concentrations of Plasma Triacylglycerols (TAG)

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

    Concentrations of 40 triacylglycerols in plasma assessed using LC-MS.Units of Measure: ng/mL

  8. Change in the Concentrations of Plasma Diglycerides (DAG)

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

    Concentrations of 4 diglycerides in plasma measured using LC-MS-based metabolomics. Units of Measure: ng/mL

  9. Change in the Concentrations of Plasma Cholesteryl Esters (CE)

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

    Concentrations of 14 cholesteryl esters in plasma determined using targeted LC-MS. Units of Measure: ng/mL

  10. Change in the Concentrations of Plasma Phosphatidylethanolamines (PE)

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

    Concentrations of 11 PE species in plasma determined using LC-MS-based metabolomics. Units of Measure: ng/mL

  11. Change in the Concentrations of Plasma Lysophosphatidylethanolamines (LPE)

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

    Concentrations of 4 LPE species in plasma assessed using LC-MS. Units of Measure: ng/mL

  12. Change in the Concentrations of Plasma Sphingomyelins (SM)

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

    Concentrations of 20 sphingomyelins in plasma measured using LC-MS-based metabolomics. Units of Measure: ng/mL

  13. Change in the Concentrations of Plasma Phosphatidylcholines (PC)

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

    Concentrations of 50 phosphatidylcholines in plasma measured using LC-MS-based targeted metabolomics. Units of Measure: ng/mL

  14. Change in the Concentrations of Plasma Lysophosphatidylcholines (LPC)

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

    Concentrations of 18 lysophosphatidylcholines in plasma determined using LC-MS metabolomic analysis. Units of Measure: ng/mL

  15. Change in the Concentrations of Plasma Ceramides

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

    Concentrations of 5 ceramides (Cer) in plasma measured by targeted LC-MS metabolomics. Units of Measure: ng/mL

  16. Change in the Concentrations of Other Polar Small Molecule Metabolites in Plasma

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

    Concentrations of 14 other polar metabolites measured in plasma using LC-MS-based targeted metabolomics. Units of Measure: μmol/L

  17. Change in the Concentrations of Plasma Carnitines and Acylcarnitines

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

    Concentrations of 12 carnitines and acylcarnitines measured in plasma using LC-MS. Units of Measure: μmol/L

  18. Change in the Concentrations of Plasma Amino Acids

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

    Concentrations of 26 amino acids measured in plasma using targeted LC-MS metabolomics. Units of Measure: μmol/L

  19. Change in the Concentrations of Tissue Plasminogen Activator (t-PA) in Serum

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

    Concentration of t-PA in serum measured using ELISA assay. Units of Measure: ng/mL

  20. Change in the Concentrations of Plasminogen Activator Inhibitor-1 (PAI-1) in Serum

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

    Concentration of PAI-1 in serum measured using ELISA assay. Units of Measure: ng/mL

  21. Change in the Concentrations of D-dimer in Serum

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

    Concentration of D-dimer in serum measured using ELISA assay. Units of Measure: ng/mL

  22. Change in the Concentrations of Fibrinogen in Serum

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

    Concentration of fibrinogen in serum measured using ELISA assay. Units of Measure: mg/dL

  23. Change in the Concentrations of Von Willebrand Factor (vWF) in Serum

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

    Concentration of Von Willebrand factor (vWF) measured in serum using ELISA assay. Units of Measure: μg/mL

  24. Change in the Concentrations of Soluble CD40 Ligand (sCD40L) in Serum

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

    Concentration of soluble CD40 ligand (sCD40L) measured in serum using ELISA assay. Units of Measure: ng/mL

  25. Change in the Mean Platelet Volume (MPV) (fL)

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

    Average size of platelets measured in the blood. Units of Measure: fL. Method of Measurement: Clinical laboratory testing.

  26. Change in the Platelet Distribution Width (PDW) (%)

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

    Measurement of variability in platelet size. Units of Measure: fL. Method of Measurement: Clinical laboratory testing

  27. Change in the Red Cell Distribution Width - Coefficient of Variation (RDW-CV) (%)

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

    RDW-CV reflects relative size variability among red blood cells. Units of Measure: %. Method of Measurement: Clinical laboratory testing

  28. Change in the Red Cell Distribution Width - Standard Deviation (RDW-SD) (fL)

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

    RDW-SD reflects variation in red cell size. Units of Measure: fL. Method of Measurement: Clinical laboratory testing.

  29. Change in the Platelet Count (PLT) (10⁹/L)

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

    Platelet count measured from plasma samples. Units of Measure: 10⁹/L. Method of Measurement: Clinical laboratory testing.

  30. Change in the Mean Corpuscular Hemoglobin Concentration (MCHC) (g/dL)

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

    Mean concentration of hemoglobin in red blood cells. Units of Measure: g/dL. Method of Measurement: Clinical laboratory testing

  31. Change in the Mean Corpuscular Hemoglobin (MCH) (pg/cell)

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

    Mean corpuscular hemoglobin value measured in plasma. Units of Measure: pg (picograms). Method of Measurement: Clinical laboratory testing

  32. Change in the Mean Corpuscular Volume (MCV) (fL)

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

    Mean corpuscular volume assessed from plasma samples. Units of Measure: fL (femtoliters). Method of Measurement: Clinical laboratory testing

  33. Change in the Hematocrit (HCT) Level (%)

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

    Hematocrit percentage measured from plasma samples.Units of Measure: %. Method of Measurement: Clinical laboratory testing

  34. Change in the Concentration of Hemoglobin Concentration (HGB) in Plasma

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

    Hemoglobin concentration in plasma measured in clinical laboratory. Units of Measure: g/dL. Method of Measurement: Clinical laboratory testing.

  35. Change in the Concentration of Red Blood Cells (RBC) in Plasma

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

    Red blood cell count measured from plasma samples using automated hematology analyzer.Units of Measure: 10¹²/L. Method of Measurement: Clinical laboratory testing.

  36. Change in the Concentration of White Blood Cells (WBC) in Plasma

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

    White blood cell count measured from plasma samples using automated hematology analyzer. Units of Measure: 10⁹/L. Method of Measurement: Clinical laboratory testing.

  37. Change in the Sleep Parameters Measured by ActiGraph GT3X-BT

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

    Objective sleep characteristics-including total sleep time, sleep efficiency, sleep latency, and wake after sleep onset-will be measured using the ActiGraph GT3X-BT wearable device. Units of Measure: Minutes for time-based parameters; percent for sleep efficiency.

  38. Change in the Pittsburgh Sleep Quality Index (PSQI) Score

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

    Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire. Units of Measure: Points on a scale.

  39. Change in the Serum Levels of Systemic Inflammatory Cytokines and Biomarkers

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

    Systemic inflammation will be assessed by measuring serum concentrations of multiple cytokines and biomarkers using the MILLIPLEX multiplex assay platform. Included analytes are: C-reactive protein (CRP) / Interleukins: IL-1β, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A / Macrophage-Derived Chemokine (MDC) / Tumor Necrosis Factor-alpha (TNF-α) / Interferon-gamma (IFN-γ) / Monocyte Chemoattractant Protein-1 (MCP-1). Units are typically pg/mL.

  40. Change in the Expression Levels of mRNAs and miRNAs in Blood and Plasma

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

    Transcriptomic profiling will be performed to measure the expression levels of mRNAs and microRNAs (miRNAs) in blood and plasma samples.

  41. Change in Cognitive Function

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

    Assessed using the Mini-Mental State Examination (MMSE, total 30 points). Cognitive impairment is defined as MMSE <27.

  42. Change in Anxiety

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

    Assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, total 7 items, maximum score 21. Severity: 0-4 none/minimal, 5-9 mild, 10-14 moderate, ≥15 severe anxiety.

  43. Change in Depression

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

    Assessed using the Patient Health Questionnaire-9 (PHQ-9), total 9 items, maximum score 27. Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression.

  44. Change in Retinal Microvascular Indicators

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

    Assessed as microvascular function indicators using fundus photography.

  45. Change in Mucosal Immunity / Respiratory System Biomarkers

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

    Measured using ELISA or Luminex, sample volume 200 µL. Indicators reflect respiratory system immune responses.

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Wang

CONTACT

[email protected]

+8618623910286

Kuai Yu

CONTACT

[email protected]

+86 15172473088

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 5, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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