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RECLEAN Pilot Study (RECLEAN)

Primary Purpose

Lead Poisoning

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-home assessment plan
Family educational session
Worker take home prevention training
D-LEAD cleaner products
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lead Poisoning focused on measuring Blood lead level, Construction workers, Household member exposure, National Health And Nutrition Examination Survey (NHANES)

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Basic intervention group

Intermediate intervention group

Advanced intervention group

Arm Description

Participants in the basic intervention group will have a 1-hour in-home assessment plan and 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 31, 2020
Last Updated
May 2, 2023
Sponsor
Boston University
Collaborators
US Department of Housing and Urban Development, Centers for Disease Control and Prevention, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04498845
Brief Title
RECLEAN Pilot Study
Acronym
RECLEAN
Official Title
RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
US Department of Housing and Urban Development, Centers for Disease Control and Prevention, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lead Poisoning
Keywords
Blood lead level, Construction workers, Household member exposure, National Health And Nutrition Examination Survey (NHANES)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After a cross sectional preliminary trial of the in-home family educational session in a one time home visit, there will be 3 types of interventions (basic, intermediate, and advanced) conducted in ~20 homes with ~50 participants for each intervention type.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Basic intervention group
Arm Type
Active Comparator
Arm Description
Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.
Arm Title
Intermediate intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Advanced intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
In-home assessment plan
Intervention Description
The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.
Intervention Type
Behavioral
Intervention Name(s)
Family educational session
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Worker take home prevention training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
D-LEAD cleaner products
Intervention Description
D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.
Primary Outcome Measure Information:
Title
Change in lead levels in dust from household wiped surfaces
Description
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
Title
Change in lead levels from household vacuumed dust
Description
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
Title
Blood metal levels from adult household members at baseline
Description
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
Title
Blood metal levels from adult household members at 5 months
Description
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
Title
Blood metal levels from child household members at baseline
Description
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
Title
Blood metal levels from child household members at 5 months
Description
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
Title
Blood metal levels from construction workers at baseline
Description
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
Title
Blood metal levels from construction workers at 5 months
Description
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
Secondary Outcome Measure Information:
Title
Change in household members' knowledge about lead exposure
Description
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
Title
Change in workers' knowledge about household lead exposure
Description
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
Title
Change in behaviors of household members
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 18 years of age or older works full time in construction with high risk for metal exposures lives in the Greater Boston area 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) speaks English or Spanish. Household resident participants must meet all of the following inclusion criteria: child (1 - 17 years of age) or adult (18 years of age or older) lives in the Greater Boston area with the worker participating in this study speaks English or Spanish. Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Ceballos Ochoa, PhD
Phone
617-358-1911
Email
ceballos@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Grant Tore, MPH
Phone
617-358-2649
Email
gdt@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Ceballos Ochoa, PhD
Organizational Affiliation
BU School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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RECLEAN Pilot Study

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