RECLEAN Pilot Study

Lead Poisoning Clinical Trial

— RECLEAN  

Official title:

RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04498845
• Other study ID #: H-40676
• Secondary ID: MALTS0013-19
• Status: Terminated
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: January 20, 2024

Study information

• Verified date: April 2024
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. To characterize pre-intervention home exposures to lead and other metals in households with one construction worker inhabitant living with a child, by assessing household members' biospecimens and home dust metal levels.

2. To develop and evaluate customized home interventions (including environmental and educational approaches) to reduce metals exposure in three tiers of intervention.

3. To characterize home exposures to lead and other metals post intervention and determine adapted behaviors and whether the degree of metals exposure reduction (including take home exposures) in the households depends on the level of intervention.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: January 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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:

1. 18 years of age or older

2. works full time in construction with high risk for metal exposures

3. lives in the Greater Boston area

4. lives with at least 1 child household member 1 year of age or older (does not have to be a child of the worker but interested in participating in the study)

5. speaks English or Spanish.

Household resident participants must meet all of the following inclusion criteria:

1. child (1 - 17 years of age) or adult (18 years of age or older)

2. lives in the Greater Boston area with the worker participating in this study

3. speaks English or Spanish.

Exclusion Criteria: None

Related Conditions & MeSH terms

• Lead Poisoning
• Poisoning

Intervention

Other:
• In-home assessment plan
The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.

Behavioral:
• Family educational session
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.
• Worker take home prevention training
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.

Other:
• D-LEAD cleaner products
D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.

Locations

Country	Name	City	State
United States	Boston University School of Public Health	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Centers for Disease Control and Prevention, Ohio State University, US Department of Housing and Urban Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 5 months
Primary	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.	Baseline, 5 months
Primary	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).	Baseline
Primary	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).	5 months
Primary	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).	Baseline
Primary	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).	5 months
Primary	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).	Baseline, 5 months
Primary	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).	Baseline, 5 months
Secondary	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.	Baseline, 1 hour after in-home family educational session
Secondary	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.	Baseline, 1 hour after worker educational session
Secondary	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.	1 month, 5 months