Clinical trial NCT07005193: Effects of LPG and Ventilation Interventions on Reducing HAP and Improving Cardiopulmonary Health
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiopulmonary Function
Environmental Exposures
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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?

Participants will be randomized in 4 groups:

A: Solid fuel + no ventilation facilities group (150 households): Continued use of solid fuels without ventilation facilities, with a one-time financial compensation provided post-intervention; B: Liquefied petroleum gas (LPG) + no ventilation facilities group (150 households): Provided with LPG stoves and instructed to use them for cooking, with regular LPG supply during the intervention period; C: Solid fuel + ventilation facilities group (150 households): Maintained solid fuel usage habits while provided with ventilation facilities and instructed to use them during cooking, with electricity costs compensated during the intervention; D: LPG + ventilation facilities group (150 households): Provided with both LPG stoves and ventilation facilities, instructed to use both during cooking, with regular LPG supply and electricity cost compensation throughout the intervention period.


Eligibility criteria: 1. Inclusion Criteria Primary Participants：

   * Primary use of solid fuels (coal, wood, charcoal, or crop residues) for cooking;
   * Kitchen is suitable for installing ventilation facilities;
   * The main cook in the household (cooking frequency ≥5 times/week);
   * Aged between 18 and 74 years;
   * Local permanent residents with no plans for long-term travel or relocation within one year.

   Secondary Participants

   ● Elderly individuals aged 65-74 who lived with the included primary participants.
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.

Primary outcomes:
measure: Change in the Number of Ultrafine particles (UFP)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of PM2.5
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Forced Vital Capacity (FVC)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Secondary outcomes:
measure: Change in the Concentrations of Specific Chemical Components in Particulate Matter
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Ozone (O₃)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Black Carbon (BC)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Systolic and Diastolic Blood Pressure
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Pulse Wave Velocity (PWV)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Forced Expiratory Flow at 75% of FVC (FEF75)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Forced Expiratory Flow at 50% of FVC (FEF50)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Forced Expiratory Flow at 25% of FVC (FEF25)
timeFrame: 1 year, with follow-ups at 6, 1 protocol.2, 24, and 36 months
measure: Change in the Peak Expiratory Flow (PEF)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Cardio-Ankle Vascular Index (CAVI)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Peripheral Arterial Tone (PAT) Index
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Environmental Noise Level
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Internal Exposure to PAHs and VOCs
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Internal Exposure to Metal Elements
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Total Volatile Organic Compounds (TVOCs)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Nitrogen Dioxide (NO₂)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of PM1 / PM10
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Other outcomes:
measure: Change in the Serum Levels of Myocardial Function Biomarkers (BNP, NT-proBNP, Follistatin, Myoglobin, CK-MB, Troponin I, Troponin T)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Serum Levels of Club Cell Protein 16 (CC16) and Surfactant Protein D (SP-D)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Serum Levels of Blood Glucose, Insulin, and C-Peptide
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Genome-wide DNA Methylation Levels in Blood Samples
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Serum Levels of Oxidative Stress Biomarkers
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Serum Levels of HPA Axis Stress Hormones (Cortisol, ACTH, CRH)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Triacylglycerols (TAG)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Diglycerides (DAG)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Cholesteryl Esters (CE)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Phosphatidylethanolamines (PE)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Lysophosphatidylethanolamines (LPE)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Sphingomyelins (SM)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Phosphatidylcholines (PC)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Lysophosphatidylcholines (LPC)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Ceramides
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Other Polar Small Molecule Metabolites in Plasma
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Carnitines and Acylcarnitines
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasma Amino Acids
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Tissue Plasminogen Activator (t-PA) in Serum
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Plasminogen Activator Inhibitor-1 (PAI-1) in Serum
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of D-dimer in Serum
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Fibrinogen in Serum
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Von Willebrand Factor (vWF) in Serum
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentrations of Soluble CD40 Ligand (sCD40L) in Serum
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Mean Platelet Volume (MPV) (fL)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Platelet Distribution Width (PDW) (%)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Red Cell Distribution Width - Coefficient of Variation (RDW-CV) (%)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Red Cell Distribution Width - Standard Deviation (RDW-SD) (fL)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Platelet Count (PLT) (10⁹/L)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Mean Corpuscular Hemoglobin Concentration (MCHC) (g/dL)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Mean Corpuscular Hemoglobin (MCH) (pg/cell)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Mean Corpuscular Volume (MCV) (fL)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Hematocrit (HCT) Level (%)
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentration of Hemoglobin Concentration (HGB) in Plasma
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentration of Red Blood Cells (RBC) in Plasma
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Concentration of White Blood Cells (WBC) in Plasma
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Sleep Parameters Measured by ActiGraph GT3X-BT
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Serum Levels of Systemic Inflammatory Cytokines and Biomarkers
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
measure: Change in the Expression Levels of mRNAs and miRNAs in Blood and Plasma
timeFrame: 1 year, with follow-ups at 6, 12, 24, and 36 months
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: Kuai Yu
role: PRINCIPAL_INVESTIGATOR
References: