RECLEAN Pilot Study

Boston University

Status: Terminated

Conditions: Lead Poisoning

Treatments: Other: D-LEAD cleaner products; Behavioral: Family educational session; Other: In-home assessment plan; Behavioral: Worker take home prevention training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04498845

H-40676

MALTS0013-19 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 3 patient groups

Basic intervention group

Active Comparator group

Description:

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

Treatment:

Behavioral: Family educational session

Other: In-home assessment plan

Intermediate intervention group

Experimental group

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.

Treatment:

Behavioral: Family educational session

Other: In-home assessment plan

Behavioral: Worker take home prevention training

Advanced intervention group

Experimental group

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.

Treatment:

Behavioral: Family educational session

Other: D-LEAD cleaner products

Other: In-home assessment plan

Behavioral: Worker take home prevention training