Clinical trial NCT05416281: Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials
Official title: Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Keywords: Environmental Exposure
Vacuum
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Exposure will be evaluated before vacuuming and again after 8 weeks of vacuuming.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Environmental Chemical Exposures
timeFrame: Participation will last through study completion, an average of 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Heather Stapleton, PhD
role: PRINCIPAL_INVESTIGATOR
References: