- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00011661
Social Network Based Intervention to Reduce Lead Exposure Among Native American Children
September 1, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
The purpose of this study is to examine whether adding an inter-generational component to an existing social network-based lay health advisor intervention increases its effectiveness in mobilizing a Native American community to respond to heavy metal contamination from lead and zinc mining.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ottawa County, Oklahoma, the site of the research, was heavily mined for zinc and lead in the first half of this century.
Mine tailings containing heavy metals are stored in large piles up to 200 feet in height.
Ottawa County is home to 8 Indian tribes and much of the mine waste is on tribal land.
Specifically, the study will: a) integrate existing Native American youth programs with the existing lay health advisor intervention (Society of Clan Mothers and Fathers) to form an inter-generational intervention, b) expand the existing lay health advisor intervention to address cadmium in addition to lead, c) use participatory research methods to involve tribal youth and adults in an air monitoring study, d) assess the extent to which the intervention contributes to belief, attitude and behavior changes that will reduce heavy metal exposure and absorption in Native American children; and e) assess the contribution of the intervention to creating changes in organizational, community, tribal and government (city, county, state, federal) capacity to address heavy metal contamination in Ottawa County, Oklahoma.
Study Type
Interventional
Enrollment
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oklahoma
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Wyandotte, Oklahoma, United States, 74370
- Wyandotte Nation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Children ages 1-6
Live in Ottawa County, Oklahoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2000
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
February 26, 2001
First Submitted That Met QC Criteria
February 27, 2001
First Posted (Estimate)
February 28, 2001
Study Record Updates
Last Update Posted (Estimate)
September 4, 2006
Last Update Submitted That Met QC Criteria
September 1, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8755-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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