Lead PoisoningNCT00011661
Social Network Based Intervention to Reduce Lead Exposure Among Native American Children
A study testing Education on behaviors to reduce lead exposure in people with Lead Poisoning, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning
- What is being tested?
- Education on behaviors to reduce lead exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Children ages 1-6
Live in Ottawa County, Oklahoma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lead Poisoning
- Being tested
- Education on behaviors to reduce lead exposure
- Keywords
- Lead poisoning, Native Americans
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on behaviors to reduce lead exposureBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2001 (estimated)
- Study startJun 2000
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011661
- Sponsor's protocol ID
- 8755-CP-001
- Status last verified
- Sep 2006
- First submitted
- 26 Feb 2001
- Last updated
- 4 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Based Intervention to Reduce Lead Exposure Among Native American Children
- ClinicalTrials.gov ID
- NCT00011661
- Acronym / sponsor ID
- 8755-CP-001
- Conditions
- Lead Poisoning
- Keywords
- Lead poisoning, Native Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Aug 2005
- First posted
- 28 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on behaviors to reduce lead exposure | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on behaviors to reduce lead exposure in people with Lead Poisoning, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2006.