Lead PoisoningRECLEANNCT04498845
RECLEAN Pilot Study
A study testing In-home assessment plan, Family educational session and Worker take home prevention training in people with Lead Poisoning, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning
- What is being tested?
- In-home assessment plan, Family educational session and Worker take home prevention training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
Official title: RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers
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.
- Conditions
- Lead Poisoning
- Being tested
- In-home assessment plan, Family educational session, Worker take home prevention training, D-LEAD cleaner products
- Keywords
- Blood lead level, Construction workers, Household member exposure, National Health And Nutrition Examination Survey (NHANES)
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home assessment planOther
The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.
Family educational sessionBehavioural
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 trainingBehavioural
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 productsOther
D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.
| Study group | Role | What they receive |
|---|---|---|
| Basic intervention group | Active comparator | Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session. Receives: 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. Receives: 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. Receives: Other: In-home assessment plan; Behavioral: Family educational session; Behavioral: Worker take home prevention training; Other: D-LEAD cleaner products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 5 months
Secondary outcomes (3)
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.
Measured: Baseline, 1 hour after in-home family educational session
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.
Measured: Baseline, 1 hour after worker educational session
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.
Measured: 1 month, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start27 Apr 2021
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Why it stopped: Principal invetigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Housing and Urban Development, Centers for Disease Control and Prevention, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Diana Ceballos Ochoa, PhD, Principal investigator, BU School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498845
- Sponsor's protocol ID
- H-40676
- Other IDs
- MALTS0013-19
- Acronym
- RECLEAN
- Status last verified
- Apr 2024
- First submitted
- 31 Jul 2020
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers
- ClinicalTrials.gov ID
- NCT04498845
- Acronym / sponsor ID
- RECLEAN / H-40676
- Conditions
- Lead Poisoning
- Keywords
- Blood lead level, Construction workers, Household member exposure, National Health And Nutrition Examination Survey (NHANES)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal invetigator left the institution.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- US Department of Housing and Urban Development, Centers for Disease Control and Prevention, Ohio State University
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Basic intervention group | Active comparator | Other: In-home assessment plan, Behavioral: Family educational sessionParticipants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session. |
| Intermediate intervention group | Experimental | Other: In-home assessment plan, Behavioral: Family educational session, Behavioral: Worker take home prevention trainingParticipants 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. |
| Advanced intervention group | Experimental | Other: In-home assessment plan, Behavioral: Family educational session, Behavioral: Worker take home prevention training, Other: D-LEAD cleaner productsParticipants 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-home assessment planThe in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment. | Other | Advanced intervention group, Basic intervention group, Intermediate intervention group |
| Family educational sessionThe 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. | Behavioural | Advanced intervention group, Basic intervention group, Intermediate intervention group |
| Worker take home prevention trainingThe 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. | Behavioural | Advanced intervention group, Intermediate intervention group |
| D-LEAD cleaner productsD-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent. | Other | Advanced intervention group |
Primary outcome
Change in lead levels in dust from household wiped surfaces
Time frame: Baseline, 5 months
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
Time frame: Baseline, 5 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 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 5 months
Time frame: Baseline, 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).
3 secondary outcomes
Change in household members' knowledge about lead exposure
Time frame: Baseline, 1 hour after in-home family educational session
Change in workers' knowledge about household lead exposure
Time frame: Baseline, 1 hour after worker educational session
Change in behaviors of household members
Time frame: 1 month, 5 months
Results and safety
The study was stopped early (reason given: Principal invetigator left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Ceballos Ochoa, PhD principal investigator
BU School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home assessment plan, Family educational session and Worker take home prevention training in people with Lead Poisoning, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal invetigator left the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lead levels in dust from household wiped surfaces (time frame: Baseline, 5 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.