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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00011661
Other study ID # 8755-CP-001
Secondary ID
Status Completed
Phase N/A
First received February 26, 2001
Last updated September 1, 2006
Start date June 2000
Est. completion date August 2005

Study information

Verified date September 2006
Source National Institute of Environmental Health Sciences (NIEHS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 6 Years
Eligibility Children ages 1-6

Live in Ottawa County, Oklahoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Education on behaviors to reduce lead exposure


Locations

Country Name City State
United States Wyandotte Nation Wyandotte Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

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