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

Environmental Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05416281
• Other study ID #: Pro00110402
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Environmental Exposure

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Environmental Chemical Exposures	Change in the mass of environmental chemicals on silicone wristbands will be evaluated after an 8-week vacuum intervention.	Participation will last through study completion, an average of 9 weeks