<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04498845</url>
  </required_header>
  <id_info>
    <org_study_id>H-40676</org_study_id>
    <secondary_id>MALTS0013-19</secondary_id>
    <nct_id>NCT04498845</nct_id>
  </id_info>
  <brief_title>RECLEAN Pilot Study</brief_title>
  <acronym>RECLEAN</acronym>
  <official_title>RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Housing and Urban Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exposure assessment pilot study tailored for families of construction workers&#xD;
      living with a child. The investigators will compare home dust metal levels and resident's&#xD;
      blood metal levels before and after an educational and environmental intervention. A baseline&#xD;
      and a post intervention period assessment will be conducted with home and car lead&#xD;
      inspections and risk assessments with collection of dust, urine, blood and toenail samples&#xD;
      and a survey.&#xD;
&#xD;
      Objectives of this research are to:&#xD;
&#xD;
        1. To characterize pre-intervention home exposures to lead and other metals in households&#xD;
           with one construction worker inhabitant living with a child, by assessing household&#xD;
           members' biospecimens and home dust metal levels.&#xD;
&#xD;
        2. To develop and evaluate customized home interventions (including environmental and&#xD;
           educational approaches) to reduce metals exposure in three tiers of intervention.&#xD;
&#xD;
        3. To characterize home exposures to lead and other metals post intervention and determine&#xD;
           adapted behaviors and whether the degree of metals exposure reduction (including take&#xD;
           home exposures) in the households depends on the level of intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 27, 2021</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in lead levels in dust from household wiped surfaces</measure>
    <time_frame>Baseline, 5 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lead levels from household vacuumed dust</measure>
    <time_frame>Baseline, 5 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood metal levels from adult household members at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood metal levels from adult household members at 5 months</measure>
    <time_frame>5 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood metal levels from child household members at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood metal levels from child household members at 5 months</measure>
    <time_frame>5 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood metal levels from construction workers at baseline</measure>
    <time_frame>Baseline, 5 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood metal levels from construction workers at 5 months</measure>
    <time_frame>Baseline, 5 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in household members' knowledge about lead exposure</measure>
    <time_frame>Baseline, 1 hour after in-home family educational session</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in workers' knowledge about household lead exposure</measure>
    <time_frame>Baseline, 1 hour after worker educational session</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behaviors of household members</measure>
    <time_frame>1 month, 5 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Lead Poisoning</condition>
  <arm_group>
    <arm_group_label>Basic intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Advanced intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In-home assessment plan</intervention_name>
    <description>The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.</description>
    <arm_group_label>Advanced intervention group</arm_group_label>
    <arm_group_label>Basic intervention group</arm_group_label>
    <arm_group_label>Intermediate intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family educational session</intervention_name>
    <description>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.</description>
    <arm_group_label>Advanced intervention group</arm_group_label>
    <arm_group_label>Basic intervention group</arm_group_label>
    <arm_group_label>Intermediate intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Worker take home prevention training</intervention_name>
    <description>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.</description>
    <arm_group_label>Advanced intervention group</arm_group_label>
    <arm_group_label>Intermediate intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>D-LEAD cleaner products</intervention_name>
    <description>D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.</description>
    <arm_group_label>Advanced intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        First, construction workers will be recruited. Second, household members of the&#xD;
        construction worker will be recruited.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Construction workers must meet all of the following inclusion criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. works full time in construction with high risk for metal exposures&#xD;
&#xD;
          3. lives in the Greater Boston area&#xD;
&#xD;
          4. lives with at least 1 child household member 1 year of age or older (does not have to&#xD;
             be a child of the worker but interested in participating in the study)&#xD;
&#xD;
          5. speaks English or Spanish.&#xD;
&#xD;
        Household resident participants must meet all of the following inclusion criteria:&#xD;
&#xD;
          1. child (1 - 17 years of age) or adult (18 years of age or older)&#xD;
&#xD;
          2. lives in the Greater Boston area with the worker participating in this study&#xD;
&#xD;
          3. speaks English or Spanish.&#xD;
&#xD;
        Exclusion Criteria: None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana Ceballos Ochoa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BU School of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diana Ceballos Ochoa, PhD</last_name>
    <phone>617-358-1911</phone>
    <email>ceballos@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grant Tore, MPH</last_name>
    <phone>617-358-2649</phone>
    <email>gdt@bu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston University School of Public Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood lead level</keyword>
  <keyword>Construction workers</keyword>
  <keyword>Household member exposure</keyword>
  <keyword>National Health And Nutrition Examination Survey (NHANES)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Lead Poisoning</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498845
org study id: H-40676
secondary id: MALTS0013-19
nct id: NCT04498845
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Change in lead levels in dust from household wiped surfaces
time frame: Baseline, 5 months
description: 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.
measure: Change in lead levels from household vacuumed dust
time frame: Baseline, 5 months
description: 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.
measure: Blood metal levels from adult household members at baseline
time frame: Baseline
description: 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).
measure: Blood metal levels from adult household members at 5 months
time frame: 5 months
description: 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).
measure: Blood metal levels from child household members at baseline
time frame: Baseline
description: 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).
measure: Blood metal levels from child household members at 5 months
time frame: 5 months
description: 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).
measure: Blood metal levels from construction workers at baseline
time frame: Baseline, 5 months
description: 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).
measure: Blood metal levels from construction workers at 5 months
time frame: Baseline, 5 months
description: 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).
measure: Change in household members' knowledge about lead exposure
time frame: Baseline, 1 hour after in-home family educational session
description: 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.
measure: Change in workers' knowledge about household lead exposure
time frame: Baseline, 1 hour after worker educational session
description: 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.
measure: Change in behaviors of household members
time frame: 1 month, 5 months
description: 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.
arm group label: Basic intervention group
arm group type: Active Comparator
description: Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.
arm group label: Intermediate intervention group
arm group type: Experimental
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.
arm group label: Advanced intervention group
arm group type: Experimental
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.
intervention type: Other
intervention name: In-home assessment plan
description: The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.
arm group label: Advanced intervention group
arm group label: Basic intervention group
arm group label: Intermediate intervention group
intervention type: Behavioral
intervention name: Family educational session
description: 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.
arm group label: Advanced intervention group
arm group label: Basic intervention group
arm group label: Intermediate intervention group
intervention type: Behavioral
intervention name: Worker take home prevention training
description: 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.
arm group label: Advanced intervention group
arm group label: Intermediate intervention group
intervention type: Other
intervention name: D-LEAD cleaner products
description: D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.
arm group label: Advanced intervention group
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Diana Ceballos Ochoa, PhD
role: Principal Investigator
affiliation: BU School of Public Health
last name: Diana Ceballos Ochoa, PhD
phone: 617-358-1911
email: ceballos@bu.edu
last name: Grant Tore, MPH
phone: 617-358-2649
email: gdt@bu.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Poisoning
mesh term: Lead Poisoning
sharing ipd: No