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临床试验/NCT02658383
NCT02658383已完成不适用

Community-Based Participatory Research: A Tool to Advance Cookstove Interventions

Colorado State University1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2015年8月最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
1
主要终点
Change in Blood pressure

研究概览

简要总结

Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. Indoor air pollution from biomass combustion accounts for an estimated 3.9 million premature deaths per year, representing about 4.8% of the global disease burden. Improved stove designs have the potential to substantially reduce indoor air pollution exposures. However, there are few randomized intervention trials, and previous stove intervention studies have been plagued by low improved stove adoption and sustained use, severely limiting interpretations of these studies. This research proposes to conduct community surveys and in-depth interviews among Honduran cookstove users to gain insight into the complex pathways surrounding barriers to and predictors of sustained improved cookstove adoption (among the target population for the proposed intervention). This information will be used to conduct and enhance a randomized improved cookstove intervention among 300 Honduran families, incorporating qualitative and quantitative measures of cookstove use and measuring pre- to post-intervention changes in pollutant exposures and subclinical indicators of cardiovascular health.

The primary goals are twofold:

  • To incorporate community-engaged approaches throughout all aspects of the research
  • To maximize sustained stove use (thereby maximizing the health impact of the intervention) to achieve valid exposure-response estimates.

Both objectives utilize innovative strategies to fill knowledge gaps. The research team will build upon previous studies in Latin America that have focused on identifying and validating appropriate field techniques for exposure and health assessments in rural areas of developing countries.

In summary, the proposed project will provide insight regarding barriers/predictors of sustained cookstove adoption, an issue impeding research in this field; assess the relationship between stove use and indicators of cardiovascular health, a substantial and quickly growing disease burden in developing countries; and result in a more comprehensive and valid assessment of the impact of a cookstove intervention.

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
None

入排标准

年龄范围
24 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primary cooks for the household
  • Uses a traditional stove
  • Latina women (representative of the rural Honduran population, no exclusions based on race/ethnicity)

排除标准

  • Non-smoking
  • Not pregnant

研究组 & 干预措施

Cleaner cookstove received after visit 2

Experimental

This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months)

干预措施: Cleaner cookstove received after visit 2 (Other)

Cleaner cookstove received after visit 4

Experimental

This arm receives the cleaner cookstove later in the study (thus acting as a control arm until after visit 4 which is after approximately 1 yr and 6 months)

干预措施: Cleaner cookstove received after visit 4 (Other)

结局指标

主要结局

Change in Blood pressure

时间窗: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.

Intention to treat analyses will incorporate the repeated measures within participants and the change in blood pressure comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.

Change in glycated hemoglobin (HbA1c)

时间窗: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.

Intention to treat analyses will incorporate the repeated measures within participants and the change in HbA1c comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.

Change in C-reactive protein (CRP)

时间窗: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.

Intention to treat analyses will incorporate the repeated measures within participants and the change in CRP comparing assigned stove type will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.

次要结局

  • Change in metabolomics(The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.)
  • Change in augmentation index and central pulse pressure(The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.)
  • Change in Inflammation(The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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