Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials

Sponsor
Duke University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05416281
Collaborator
(none)
150
1
2
21.7
6.9

Study Details

Study Description

Brief Summary

This project will evaluate new approaches to quantify and reduce chemical exposures from common building materials, with an emphasis on plastic additives, pesticides, flame retardants and lead in addition to other environmental contaminants. The objective of this project is to develop methods to quantify and reduce chemical exposures from the home environment using approaches that are adaptable and customizable to individuals and households. To achieve this goal investigators will: 1) Identify the types of building materials and housing characteristics associated with higher levels of exposure to different classes of contaminants; 2) Assess the effectiveness of a simple robotic vacuuming intervention for reducing exposure to a range of indoor contaminants; and 3) Evaluate a new wearable silicone wristband for monitoring exposure to lead and other metals.

Condition or Disease Intervention/Treatment Phase
  • Other: Robotic Vacuum
N/A

Detailed Description

This study will leverage Project HOPE 1000 (Duke University Health System IRB Pro00100000), an existing longitudinal pregnancy cohort study. Investigators will invite a subset of women participating in HOPE 1000 (n=150) to participate in an environmental assessment involving home visits by a research team. Separate informed consent will be obtained from all participants. During home visits, environmental samples will be collected (e.g. dust and water) and participants will complete a questionnaire. A smaller subset of participants (n=50) will be asked to wear a silicone wristband to monitor ambient exposure to metals. Finally, to evaluate whether robotic vacuums can reduce exposure to environmental chemicals in the home, investigators will deploy robotic vacuum cleaners (i.e., Roomba) in 50 participants' homes. Investigators will measure a range of environmental contaminants and chemicals in environmental samples. This information will be combined with data and samples collected under the HOPE 1000 protocol. In particular, investigators will analyze maternal blood samples which have already been banked for metals and will analyze previously collected silicone wristbands for the same environmental chemicals targeted in previously collected samples.

Investigators will evaluate statistical associations between contaminants in the home and occupants' exposure. Investigators will also investigate changes in exposure before and after the intervention program. Risk to study participants includes the potential loss of confidentiality.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Exposure will be evaluated before vacuuming and again after 8 weeks of vacuuming.Exposure will be evaluated before vacuuming and again after 8 weeks of vacuuming.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials
Actual Study Start Date :
Aug 11, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Robotic Vacuum Intervention

This will include a home visit for environmental assessment AND a robotic vacuum intervention. Silicone wristbands will be used to evaluate exposure before and after a cleaning intervention.

Other: Robotic Vacuum
Participants will be provided with a Roomba iRobot vacuum and will be asked to use the vacuum in their home for 8 weeks. Exposure to environmental exposures will be evaluated before and after the intervention using silicone wristbands.

No Intervention: No Intervention

This will include a home visit for environmental assessment.

Outcome Measures

Primary Outcome Measures

  1. Change in Environmental Chemical Exposures [Participation will last through study completion, an average of 9 weeks]

    Change in the mass of environmental chemicals on silicone wristbands will be evaluated after an 8-week vacuum intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants enrolled in Project HOPE 1000, a pregnancy cohort study at Duke University Medical Center.

  • Any enrolled HOPE 1000 participants planning to remain in their homes for at least the following 12 weeks will be eligible for our sub-studies.

Exclusion Criteria:
  • Individuals not planning to remain in their homes for at least 12 weeks.

  • Those not able to communicate in fluent English will be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27708

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Heather Stapleton, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05416281
Other Study ID Numbers:
  • Pro00110402
First Posted:
Jun 13, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University

Study Results

No Results Posted as of Aug 19, 2022