NCT05416281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

November 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2.2 years

First QC Date

June 5, 2022

Last Update Submit

November 14, 2024

Conditions

Keywords

Environmental ExposureVacuum

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Robotic Vacuum Intervention

EXPERIMENTAL

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

No Intervention

NO INTERVENTION

This will include a home visit for environmental assessment.

Interventions

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.

Robotic Vacuum Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals not planning to remain in their homes for at least 12 weeks.
  • Those not able to communicate in fluent English will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Study Officials

  • Heather Stapleton, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Exposure will be evaluated before vacuuming and again after 8 weeks of vacuuming.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 13, 2022

Study Start

August 11, 2022

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

November 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations