跳至主要内容
临床试验/NCT03726957
NCT03726957进行中(未招募)不适用

Exploring Respiratory Health Outcomes From Sustained Use of Efficient Cookstoves

Boston College0 个研究点目标入组 208 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
208
主要终点
Forced Expiratory Volume 1 (FEV1)

研究概览

简要总结

Household air pollution (HAP) is a leading risk factor for global burden of disease. Resource-constrained communities of the world especially women and children are significantly impacted by this challenge. To address household air pollution, cleaner and more efficient improved cookstoves (ICS) have been disseminated to low resource communities. Although there has been initial uptake of these stoves, sustained use has been inconsistent adding to the challenge of household air pollution. There is limited understanding at the intersections of social, ecological, and technical determinants of sustained use of ICS, and how is sustained use of ICS associated with exposure and health outcomes in poor communities.

The overarching goal of this exploratory study is to initiate a comprehensive research program that will facilitate the use of ICS and investigate whether they render significant health benefits among rural Indian households.

The investigators installed ICS (model: Eco-Chulla XXL) in select households that primarily use biomass for cooking, and evaluate the intervention based on three specific aims:

  1. To generate preliminary emissions data [particulate matter - mass and surface area based, carbon monoxide (CO)] from ICS and its effect on respiratory health outcomes that will facilitate the development of a pivotal clean cookstove intervention
  2. To generate effect size data that establish the feasibility and inform the sample size of a pivotal trial whose primary objective will be sustained improvements in the respiratory health of women and children in rural India
  3. To evaluate factors which enable and hinder the sustained use of clean cookstove technologies by the rural poor in India so that the investigators can develop a more refined pivotal intervention focused on improving respiratory health

详细描述

In this study, the investigators undertake a 12-month cluster randomized trial in 96 households in the rural areas of Andhra Pradesh and Karnataka states of India. The investigators enrolled women (primary cook) and one child (age 8-15) in each of these 96 households. The investigators compare the effect of traditional wood burning stoves (the control condition) to that of improved wood burning stoves on the respiratory health of women and children, and also undertake community-based system dynamics modeling to delineate the feedback mechanisms involved in sustained use or abandonment of improved cookstoves. The study and research program are aligned with recent international attention to explore determinants impacting the sustained use of cleaner cooking systems in poor communities of the world. Thus, in achieving the aims of this R21, the investigators will then have: 1) necessary preliminary data; 2) pre-emptive strategies for most of these unanticipated but preventable challenges. The investigators will leverage these insights to proceed with a larger scale intervention: 1) to examine the effect of sustained use of cleaner cooking systems and respiratory health outcomes in women and children due to reduced HAP in rural India; 2) to explore barriers and enablers of implementation of cleaner cooking systems in multiple resource poor settings. Numerous studies have shown that sustained and exclusive use of cleaner cooking systems irrespective of their types have been a challenge. Lukewarm sustenance of cleaner cooking systems in poor households stems from a limited understanding on the grounds of social, technical, economic, and ecological intersections of energy security. The investigators intend to address this gap by using a trans-disciplinary approach to contribute to our understanding of factors that influence the implementation of cleaner cooking systems for rural poor in India.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •The household had a traditional wood burning cookstove and had at least one woman (primary cook) at least the age of 18, and one child between age 8-15 (both included).
  • •If a household had more than one child within the target age range, the oldest child within the age range was selected for study.

排除标准

  • •Both the woman and the child could not successfully undertake spirometry.

研究组 & 干预措施

Intervention group

Experimental

The intervention arm included households which received improved cookstoves

干预措施: Improved Cookstoves (Behavioral)

Control group

No Intervention

The control group included households, which did not receive improved cookstoves, and cooked in their usual traditional cookstoves.

结局指标

主要结局

Forced Expiratory Volume 1 (FEV1)

时间窗: 12 months

The investigators used Koko spirometer to measure the forced expiratory volume in 1 second (FEV1).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验