RECLEAN Pilot Study

NCT ID: NCT04498845

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2024-01-20

Brief Summary

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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

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Conditions

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Lead Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Basic intervention group

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

Group Type ACTIVE_COMPARATOR

In-home assessment plan

Intervention Type OTHER

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

Family educational session

Intervention Type 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.

Intermediate intervention group

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.

Group Type EXPERIMENTAL

In-home assessment plan

Intervention Type OTHER

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

Family educational session

Intervention Type 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.

Worker take home prevention training

Intervention Type 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

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.

Group Type EXPERIMENTAL

In-home assessment plan

Intervention Type OTHER

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

Family educational session

Intervention Type 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.

Worker take home prevention training

Intervention Type 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.

D-LEAD cleaner products

Intervention Type OTHER

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

Interventions

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In-home assessment plan

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

Intervention Type OTHER

Family educational session

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

Worker take home prevention training

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 BEHAVIORAL

D-LEAD cleaner products

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

Intervention Type OTHER

Eligibility Criteria

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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.


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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Housing and Urban Development

FED

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Ceballos Ochoa, PhD

Role: PRINCIPAL_INVESTIGATOR

BU School of Public Health

Locations

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Boston University School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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MALTS0013-19

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-40676

Identifier Type: -

Identifier Source: org_study_id

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