NCT07005193

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. 1.Does LPG substitution or improved ventilation reduce HAP and improve cardiopulmonary health?
  2. 2.Would the combined intervention of LPG substitution and improved ventilation outperform single interventions?
  3. 3.What is the cost-effectiveness of such interventions, and are they sustainable?
  4. 4.Does the intervention reduce the incidence of cardiopulmonary clinical events?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jul 2025Jun 2029

First Submitted

Initial submission to the registry

May 8, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

March 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

May 8, 2025

Last Update Submit

March 15, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

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

Secondary Outcomes (29)

  • Change in the Concentrations of Specific Chemical Components in Particulate Matter

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

  • Change in the Concentrations of Ozone (O₃)

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

  • Change in the Concentrations of Black Carbon (BC)

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

  • Change in the Systolic and Diastolic Blood Pressure

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

  • Change in the Fractional Exhaled Nitric Oxide (FeNO)

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

  • +24 more secondary outcomes

Other Outcomes (45)

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

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

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

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

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

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

  • +42 more other outcomes

Study Arms (4)

A: Solid fuel + no ventilation (control).

OTHER

Solid fuel + no ventilation facilities group: 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.

Behavioral: Using solid fuels for cookingBehavioral: No ventilation during cooking

B: LPG + no ventilation.

EXPERIMENTAL

Liquefied petroleum gas (LPG) + no ventilation facilities group: 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.

Behavioral: Using liquefied gas for cookingBehavioral: No ventilation during cooking

C: Solid fuel + ventilation.

EXPERIMENTAL

Solid fuel + ventilation facilities group: 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.

Device: Cooking ventilation facilitiesBehavioral: Using solid fuels for cooking

D: LPG + ventilation.

EXPERIMENTAL

LPG + ventilation facilities group: 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.

Device: Cooking ventilation facilitiesBehavioral: Using liquefied gas for cooking

Interventions

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

C: Solid fuel + ventilation.D: LPG + ventilation.

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

B: LPG + no ventilation.D: LPG + ventilation.

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

A: Solid fuel + no ventilation (control).C: Solid fuel + ventilation.

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

A: Solid fuel + no ventilation (control).B: LPG + no ventilation.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Suiping County Health Center

Zhumadian, Henan, 4630000, China

NOT YET RECRUITING

Hong'an County Health Center

Huanggang, Hubei, 438000, China

RECRUITING

Longhui County Health Center

Shaoyang, Hunan, 422000, China

NOT YET RECRUITING

MeSH Terms

Interventions

Cooking

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

Study Officials

  • Kuai Yu

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Fellow, Principal Investigator

Study Record Dates

First Submitted

May 8, 2025

First Posted

June 5, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

March 17, 2026

Record last verified: 2026-02

Locations