MedPath

RECLEAN Pilot Study

Not Applicable
Terminated
Conditions
Lead Poisoning
Interventions
Other: In-home assessment plan
Behavioral: Family educational session
Behavioral: Worker take home prevention training
Other: D-LEAD cleaner products
Registration Number
NCT04498845
Lead Sponsor
Boston University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
35
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Advanced intervention groupIn-home assessment planParticipants 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.
Basic intervention groupFamily educational sessionParticipants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.
Intermediate intervention groupIn-home assessment planParticipants 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.
Intermediate intervention groupWorker take home prevention trainingParticipants 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.
Basic intervention groupIn-home assessment planParticipants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.
Intermediate intervention groupFamily educational sessionParticipants 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.
Advanced intervention groupFamily educational sessionParticipants 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.
Advanced intervention groupWorker take home prevention trainingParticipants 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.
Advanced intervention groupD-LEAD cleaner productsParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change in lead levels from household vacuumed dustBaseline, 5 months

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.

Blood metal levels from adult household members at baselineBaseline

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).

Change in lead levels in dust from household wiped surfacesBaseline, 5 months

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.

Blood metal levels from child household members at baselineBaseline

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).

Blood metal levels from adult household members at 5 months5 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).

Blood metal levels from construction workers at baselineBaseline, 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).

Blood metal levels from construction workers at 5 monthsBaseline, 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).

Blood metal levels from child household members at 5 months5 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).

Secondary Outcome Measures
NameTimeMethod
Change in workers' knowledge about household lead exposureBaseline, 1 hour after worker educational session

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.

Change in behaviors of household members1 month, 5 months

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.

Change in household members' knowledge about lead exposureBaseline, 1 hour after in-home family educational session

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.

Trial Locations

Locations (1)

Boston University School of Public Health

🇺🇸

Boston, Massachusetts, United States

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