RECLEAN Pilot Study

NCT04498845 | Terminated

• 2 other identifiers: H-40676MALTS0013-19
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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. 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. 2.To develop and evaluate customized home interventions (including environmental and educational approaches) to reduce metals exposure in three tiers of intervention.
3. 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.

Conditions

Lead Poisoning

Keywords

Blood lead level; Construction workers; Household member exposure; National Health And Nutrition Examination Survey (NHANES)

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in household members' knowledge about lead exposure

  Baseline, 1 hour after in-home family educational session

• Change in workers' knowledge about household lead exposure

  Baseline, 1 hour after worker educational session

• Change in behaviors of household members

  1 month, 5 months

Study Arms (3)

Basic intervention group

ACTIVE COMPARATOR

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

Intermediate intervention group

EXPERIMENTAL

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

Advanced intervention group

EXPERIMENTAL

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

Interventions

In-home assessment plan OTHER

The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.

Advanced intervention group; Basic intervention group; Intermediate intervention group

Family educational session BEHAVIORAL

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.

Advanced intervention group; Basic intervention group; Intermediate intervention group

Worker take home prevention training BEHAVIORAL

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.

Advanced intervention group; Intermediate intervention group

D-LEAD cleaner products OTHER

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

Advanced intervention group

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boston University: lead
• US Department of Housing and Urban Development: collaborator
• Centers for Disease Control and Prevention: collaborator
• Ohio State University: collaborator

Study Sites (1)

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Lead Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Diana Ceballos Ochoa, PhD

  BU School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: April 27, 2021
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)