- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03048630
Reducing Chemical Exposures in Nail Salons (KHOEDEP)
Reducing Chemical Exposures in Nail Salons Using an Owner-to-Worker Intervention
Study Overview
Detailed Description
The primary hypothesis is that there will be a significantly greater reduction in measured levels of air contaminants among workers in the intervention group than in the comparison group. The primary outcome of interest is workplace chemical exposure reduction.
In addition, the secondary hypotheses are:
- The proportion of workers who have increased knowledge of workplace chemical exposure reduction (WCER) will be significantly greater in the intervention group than in the comparison group.
- The proportion of workers who report having modified behavioral and environmental factors that facilitate WCER will increase significantly more in the intervention group than the comparison group.
- The proportion of workers with decreased work-related health problems will be greater in the intervention group than the comparison group.
As part of the secondary analyses, the investigators will also examine whether changes in knowledge and behavior are associated with workplace chemical exposure reduction and also whether changes in workplace chemical exposure are associated with improved health. The specific aims are to:
- Enhance existing workplace chemical exposure reduction (WCER) education materials and survey instruments that target Vietnamese nail salon owners and workers.
- Implement an owner-to-worker intervention to administer the WCER education materials.
Evaluate the effectiveness of the owner-to-worker WCER intervention for:
- reducing the primary outcome of measured personal levels of air contaminants (e.g., toluene, methyl methacrylate, methyl ethyl ketone, and total volatile organic compounds) in workers;
- influencing the secondary outcomes which include:
i) increasing worker knowledge of WCER
ii) modifying behavioral and environmental factors that promote WCER
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94704
- Cancer Prevention Institute of California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nail salon workers and owners who speak and/or write Vietnamese
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Knowledge and behavioral intervention
Owner and worker trainings regarding knowledge and behaviors associated with workplace chemical exposure reduction
|
Owner-to-Worker training about reducing chemical exposures in nail salons
|
|
Other: Delayed intervention
Delayed knowledge and behavioral intervention
|
Owner-to-Worker training about reducing chemical exposures in nail salons
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduced measured workplace chemicals by air monitoring
Time Frame: from 4 to 6 months
|
from 4 to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Behavior and knowledge change by questionnaire
Time Frame: from 4 to 6 months
|
from 4 to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2012-008 (Other Identifier: Kantonale Ethikkommission AG/ SO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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