An interventional study of In-home assessment plan and Family educational session in Lead Poisoning, sponsored by Boston University. Terminated at 1 site in United States. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
This is an exposure assessment pilot study tailored for families of construction workers living with a child. The investigators will compare home dust metal levels and resident's blood metal levels before and after an educational and environmental intervention. A baseline and a post intervention period assessment will be conducted with home and car lead inspections and risk assessments with collection of dust, urine, blood and toenail samples and a survey.
Objectives of this research are to:
27 studies on the registry are indexed under Lead Poisoning; 3 are open to participants now.
This study's enrollment of 35 is below the median of 175 across 11 interventional studies indexed under Lead Poisoning.
Browse Lead Poisoning studies →Boston University is the lead sponsor of 270 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
First, construction workers will be recruited. Second, household members of the construction worker will be recruited.
Inclusion Criteria:
Construction workers must meet all of the following inclusion criteria:
Household resident participants must meet all of the following inclusion criteria:
Exclusion Criteria: None
Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.
Other: In-home assessment plan · Behavioral: Family educational session
Participants in the intermediate intervention group will have a 1-hour in-home assessment plan and educational session and refer worker to a 1-hr worker take home prevention educational session.
Other: In-home assessment plan · Behavioral: Family educational session · Behavioral: Worker take home prevention training
Participants in the advanced intervention group will have a 1-hour in-home assessment plan and educational session, refer worker to a 1-hr worker take home prevention educational session, and provision of D-LEAD all-purpose cleaner and laundry detergent.
Other: In-home assessment plan · Behavioral: Family educational session · Behavioral: Worker take home prevention training · Other: D-LEAD cleaner products
The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.
The 1-hr in-home family educational session, administered during the first home visit to all participants, adapts a motivational interview model to reduce exposure to metals. this done by empowering families to make informed decisions regarding lead and metal exposures in their home environments that originate from different sources with an emphasis on sources from the workplace. The session will consist of both developing a plan tailored for the home and reviewing educational materials on strategies to reduce exposures in the home, focusing on barriers families experience when attempting to change their behaviors.
The take home prevention 1-hour educational session guides the worker through 6 simple steps to identify and then prioritize change/s that can be made before leaving work to prevent take-home lead. It has been adapted from the AGILE model for prioritizing tasks. Participants will also be provided with a pamphlet about how to prevent lead from being taken home.
D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.
Change in lead levels in dust from household wiped surfaces
Dust samples will be collected in the home from wiping up to ten 1ft by 1ft surfaces in the home and three wipes in the car following HUD methods from smooth surfaces likely to be contaminated by the worker and that likely expose other family members such as the laundry area, entry walkway, and living room area, as well as areas with potential lead like window sills. Investigators will use SKC 550-002 colorimetric wipe kit for lead on all wipes in order to obtain immediate color response in the presence of lead (reddish color suggests lead). Wipes will be then stored to be sent to the laboratory for quantitative elemental analysis.
Time frame: Baseline, 5 months
Change in lead levels from household vacuumed dust
Dust samples will be collected by vacuuming the entire home floors and surfaces into a clean sampling thimble. Participants will be asked not to vacuum the house, if possible, at least one week prior to the scheduled home visit, tso that enough dust is available for testing.
Time frame: Baseline, 5 months
Blood metal levels from adult household members at baseline
During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).
Time frame: Baseline
Blood metal levels from adult household members at 5 months
During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).
Time frame: 5 months
Blood metal levels from child household members at baseline
During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).
Time frame: Baseline
Blood metal levels from child household members at 5 months
During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).
Time frame: 5 months
Blood metal levels from construction workers at baseline
During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).
Time frame: Baseline, 5 months
Blood metal levels from construction workers at 5 months
During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).
Time frame: Baseline, 5 months
Change in household members' knowledge about lead exposure
Investigator developed pre- and post-assessments will be administered to participating household members after the in-home family educational session to evaluate their knowledge regarding potential for exposure to lead in their home environment, especially as it relates to the worker's job in construction, and strategies to prevent or reduce that potential for exposure. Higher number of correct answers are associated with greater knowledge.
Time frame: Baseline, 1 hour after in-home family educational session
Change in workers' knowledge about household lead exposure
Investigator developed pre- and post-assessments will be administered to participating workers after the worker educational session to evaluate their knowledge regarding take-home lead exposure, especially as it relates to their job in construction, and strategies to prevent or reduce that potential for exposure. Higher number of correct answers are associated with greater knowledge.
Time frame: Baseline, 1 hour after worker educational session
Change in behaviors of household members
Self-reported behaviors of household members regarding prevention of lead exposure will be assessed from responses to an investigator developed survey that will be administered after the first and second home visits. The follow-up survey will ask questions on the behavior change of participants since the first home visit and how successfully they have adhered to their home action plan and to describe any challenges they may have faced.
Time frame: 1 month, 5 months
Plan to share: No
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Ran from Apr 2021 to primary completion in Jan 2024, 32 months.
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