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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Cooking ventilation facilities
  Installation and use of kitchen ventilation facilities (e.g., range hood) during cooking to reduce indoor air pollution exposure.
• Поведенческое Using liquefied gas for cooking
  Households are provided with liquefied gas stoves and encouraged to use liquefied gas instead of solid fuels for cooking.
• Поведенческое Using solid fuels for cooking
  Households continue using traditional solid fuels (e.g., coal or biomass) for cooking according to their usual practices.
• Поведенческое No ventilation during cooking
  Households continue cooking without installing additional ventilation facilities during the intervention period.

Первичные конечные точки

• Change in the Number of Ultrafine particles (UFP) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Concentrations of PM2.5 [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Forced Vital Capacity (FVC) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]

Вторичные конечные точки (12)

• Change in the Concentrations of Specific Chemical Components in Particulate Matter [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Concentrations of Ozone (O₃) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Concentrations of Black Carbon (BC) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Systolic and Diastolic Blood Pressure [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Fractional Exhaled Nitric Oxide (FeNO) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Change in the Pulse Wave Velocity (PWV) [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Incidence of Obesity and Central Obesity [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Incidence of Diabetes [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Incidence of Dyslipidemia [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Incidence of Hypertension [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Incidence of Acute Exacerbation of Chronic Bronchitis [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]
• Incidence of Acute Respiratory Infection [Срок оценки: 1 year, with follow-ups at 6, 12, 24, and 36 months]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 3 центра

• Suiping County Health Center — Zhumadian
• Hong'an County Health Center — Huanggang
• Longhui County Health Center — Shaoyang

Идентификаторы

NCT: NCT07005193 · 2023ZD0509900

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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