Clinical trial NCT04498845: RECLEAN Pilot Study
Official title: RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lead Poisoning
Keywords: Blood lead level
Construction workers
Household member exposure
National Health And Nutrition Examination Survey (NHANES)
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: US Department of Housing and Urban Development
name: Centers for Disease Control and Prevention
name: Ohio State University
First posted: 2020-08-05
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


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:

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

Primary outcomes:
measure: Change in lead levels in dust from household wiped surfaces
timeFrame: Baseline, 5 months
measure: Change in lead levels from household vacuumed dust
timeFrame: Baseline, 5 months
measure: Blood metal levels from adult household members at baseline
timeFrame: Baseline
measure: Blood metal levels from adult household members at 5 months
timeFrame: 5 months
measure: Blood metal levels from child household members at baseline
timeFrame: Baseline
measure: Blood metal levels from child household members at 5 months
timeFrame: 5 months
measure: Blood metal levels from construction workers at baseline
timeFrame: Baseline, 5 months
measure: Blood metal levels from construction workers at 5 months
timeFrame: Baseline, 5 months
Secondary outcomes:
measure: Change in household members' knowledge about lead exposure
timeFrame: Baseline, 1 hour after in-home family educational session
measure: Change in workers' knowledge about household lead exposure
timeFrame: Baseline, 1 hour after worker educational session
measure: Change in behaviors of household members
timeFrame: 1 month, 5 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Public Health
state: Massachusetts
Study officials:
affiliation: BU School of Public Health
name: Diana Ceballos Ochoa, PhD
role: PRINCIPAL_INVESTIGATOR
References: