Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Particulate matter of 2.5 μm in size (household air pollutant)
研究概览
简要总结
The purpose of this randomized controlled field trial is to determine whether a liquefied petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen exposure to household air pollutants and improves cardiopulmonary health outcomes when compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged 25-64 years.
详细描述
Randomized, controlled field trial of an LPG stove and fuel distribution intervention compared to standard cooking practices with open-fire biomass-burning stoves in the homes of participating adult women aged 25-64 years. The aim is to determine whether provision of cleaner fuels will result in important reductions in household air pollutants and consequently in an improvement in cardiopulmonary health outcomes over a one-year period. Participants randomly assigned to the intervention arm will receive a free LPG stove and fuel delivered to their homes during the one-year intervention period. Participants randomly assigned to the control arm will receive a free LPG stove and vouchers that can be used to obtain free fuel for an entire year at LPG fuel distribution centers at the end of the one-year intervention period. All participants will be followed for a second year to assess patterns and impacts of sustained use (intervention arm) and initial adoption (control arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The clinical team is masked in this study, and a portion of the investigators.
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Full-time resident ≥6 months in current location
- •Capable of understanding procedures
- •Capable of providing informed consent and responding to a questionnaire
- •Primary household cook
- •Currently using a traditional stove as primary stove for cooking
- •Cooking room/area separate from sleeping room/area to minimize probability of use of biomass fuel stoves for heating living space.
排除标准
- •Plans to move from the area within one year
- •Uncontrolled hypertension
- •Diagnosis of chronic obstructive pulmonary disease (COPD)
- •Pregnant or planning pregnancy in the next year
结局指标
主要结局
Particulate matter of 2.5 μm in size (household air pollutant)
时间窗: One year
Specific Aim: Demonstrate sustained reductions in personal and kitchen particulate matter concentrations after distribution of an LPG stove and fuel tanks twice monthly over a one-year period. Hypothesis: Use of LPG stoves for cooking by participants in the intervention arm will result in a sustained reduction in personal and kitchen air pollutant concentrations when compared to those with the control arm during the one year intervention period.
Respiratory symptoms (respiratory health endpoint)
时间窗: One year
Specific Aim: Demonstrate sustained reduction in respiratory symptoms after LPG stove intervention. Hypothesis: Women in the intervention arm will have fewer respiratory symptoms as measured by a lower St. Georges Respiratory Symptoms Questionnaire score when compared with those in the control arm during the one year intervention period.
Peak expiratory flow (respiratory health endpoint)
时间窗: One year
Specific Aim: Demonstrate sustained improvement in peak expiratory flow after LPG stove intervention. Hypothesis: Women in the intervention arm will have a higher peak expiratory flow as measured by spirometry when compared with those in the control arm during the one year intervention period.
Carbon monoxide (household air pollutant)
时间窗: One year
Specific Aim: Demonstrate sustained reductions in personal and kitchen carbon monoxide concentrations after distribution of an LPG stove and fuel tanks twice monthly over a one-year period. Hypothesis: Use of LPG stoves for cooking by participants in the intervention arm will result in a sustained reduction in personal and kitchen carbon monoxide concentrations when compared to those with the control arm during the one year intervention period.
Blood pressure (cardiovascular health endpoint)
时间窗: One year
Specific Aim: Demonstrate sustained reduction in blood pressure after LPG stove intervention. Hypothesis: Women in the intervention arm will have lower blood pressure when compared with those in the control arm during the one year intervention period.
Flow mediated dilation (cardiovascular health endpoint)
时间窗: One year
Specific Aim: Demonstrate a sustained improvement in endothelial function after LPG stove intervention. Hypothesis: Women in the intervention arm will have better endothelial function as measured by flow mediated dilation when compared with those in the control arm during the one year intervention period.
Carotid intima media thickness (cardiovascular health endpoint)
时间窗: One year
Specific Aim: Demonstrate lower progression in carotid intima media thickness after LPG stove intervention. Hypothesis: Women in the intervention arm will have a lower rate of atherosclerosis progression as measured by carotid artery ultrasound assessment of the carotid intima-media complex over a one-year period when compared with those in the control arm during the one year intervention period.
Forced expiratory volume at one second (respiratory health endpoint)
时间窗: One year
Specific Aim: Demonstrate higher forced expiratory volumes at one second after LPG stove intervention. Hypothesis: Women in the intervention arm will have higher height- and age-adjusted, pre- and post-bronchodilator forced expiratory volume at one second as measured by spirometry over a one-year period when compared with those in the control arm during the one year intervention period.
次要结局
- Exhaled carbon monoxide(One year)
- Diet(One year)
- Inflammatory metabolites(One year)
- Quality-adjusted life years(One year)
- Compliance with stove use(One year)
- Urinary sodium(One year)
- Percentage of households with sustained LPG stove use in intervention arm(One year)
- Percentage of households who adopted LPG stove use in the control arm(One year)