Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Urine arsenic concentrations in household members
研究概览
简要总结
Develop and evaluate the effectiveness of multi-level participatory interventions in reducing arsenic exposure among American Indian (AI) communities from North and South Dakota who participated in the Strong Heart Study (SHS).
详细描述
Design, implement, and evaluate multi-level participatory interventions that can lead to a sustained reduction in arsenic exposure in adults and children in Cheyenne River, Oglala, and Spirit Lake communities in North/South Dakota by: 1) building local capacity at the tribal and community levels to ensure the long-term sustainability of the interventions. 2) conduct a 2-arm cluster-randomized controlled trial comparing arsenic removal device only to removal device and intensive education and promotion among 300 households, 600 participants.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Arsenic levels in household drinking water must be ≥10 µg/L
- •Households must have ≥1 adult ≥18 years of age eligible and willing to participate.
- •Household must have an active well on the property that is used for drinking water.
- •Household must have indoor plumbing and a permanent heat source.
- •Participant must plan to reside in the household for the next year, must reside in the residence for ≥4 days/week, and year round (i.e. all seasons).
- •≥1 household members must identify as American Indian.
- •Household must be willing to grant study members access to the interior of their household for screening and data collection.
排除标准
- •Arsenic levels in household drinking water <10 µg/L
- •Households with no adult ≥18 years of age eligible and willing to participate.
- •Households without an active well on the property that is used for drinking water (i.e. connected to municipal water supply).
- •Households without indoor plumbing and/or a permanent heat source.
- •Participant planning to reside in the household <1 year, residing in the residence for <4 days/week, or not year round (i.e. not during all seasons).
- •No household member identifies as American Indian.
- •Household unwilling to grant study members access to the interior of their household for screening and data collection.
研究组 & 干预措施
Intensive Education
Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
干预措施: Standard Treatment (Other)
Intensive Education
Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
干预措施: Intensive Education (Behavioral)
Standard Treatment
Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)
干预措施: Standard Treatment (Other)
结局指标
主要结局
Urine arsenic concentrations in household members
时间窗: 6 months post-installation of the arsenic removal device
(1a) urine arsenic concentrations among household members (in parts per billion, µg/L)
次要结局
- Water usage from arsenic removal device(6 months post-installation of the arsenic removal device)
- Biomarkers of pulmonary function(6 months post-installation of the arsenic removal device)
- Biomarkers of diabetes(6 months post-installation of the arsenic removal device)
- Arsenic concentrations in filtered water(6 months post-installation of the arsenic removal device)
- Long-term functionality of arsenic removal device(1 year post-installation of the arsenic removal device)
- Blood pressure(6 months post-installation of the arsenic removal device)
- Long-term maintenance of arsenic removal device(1 year post-installation of the arsenic removal device)
- Biomarkers of cardiovascular disease(6 months post-installation of the arsenic removal device)
- Long-term water usage from arsenic removal device(1 year post-installation of the arsenic removal device)
- Long-term urine arsenic concentrations in household members(1 year post-installation of the arsenic removal device)