Strong Heart Water Study
- Conditions
- Arsenic Poisoning
- Interventions
- Other: Standard TreatmentBehavioral: Intensive Education
- Registration Number
- NCT03725592
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 57
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive Education Standard Treatment Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation) Standard Treatment Standard Treatment Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device) Intensive Education Intensive Education Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
- Primary Outcome Measures
Name Time Method Urine arsenic concentrations in household members 6 months post-installation of the arsenic removal device (1a) urine arsenic concentrations among household members (in parts per billion, µg/L)
- Secondary Outcome Measures
Name Time Method Biomarkers of diabetes 6 months post-installation of the arsenic removal device (2d) biomarkers of diabetes (hemoglobin A1c) in household members
Arsenic concentrations in filtered water 6 months post-installation of the arsenic removal device (2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Long-term functionality of arsenic removal device 1 year post-installation of the arsenic removal device (2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Blood pressure 6 months post-installation of the arsenic removal device (2f) systolic and diastolic blood pressure levels
Long-term maintenance of arsenic removal device 1 year post-installation of the arsenic removal device (2j) long-term sustainability assessment to evaluate self-reported maintenance of the arsenic removal device (Did household change the device filter when indicated by light on spigot? Does household have replacement filter(s) available for subsequent filter change(s)?)
Biomarkers of cardiovascular disease 6 months post-installation of the arsenic removal device (2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members
Long-term water usage from arsenic removal device 1 year post-installation of the arsenic removal device (2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)
Water usage from arsenic removal device 6 months post-installation of the arsenic removal device (2b) water usage from removal device (from flow meter, in gallons)
Biomarkers of pulmonary function 6 months post-installation of the arsenic removal device (2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)
Long-term urine arsenic concentrations in household members 1 year post-installation of the arsenic removal device (2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)
Trial Locations
- Locations (1)
Johns Hopkins Bloomberg School of Public Health, ICTR
🇺🇸Baltimore, Maryland, United States