Occupational ExposureKHOEDEPNCT03048630
Reducing Chemical Exposures in Nail Salons
A study testing Education in people with Occupational Exposure, run by Cancer Prevention Institute of California at 1 site in United States.
Trial summary
In this intervention study, the investigators engage Vietnamese American nail salon owners to train workers within their salons on how to reduce workplace chemical exposures. The long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote worker health and safety in this vulnerable… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nail salon workers and owners who speak and/or write Vietnamese
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Prevention Institute of California
Berkeley, California, 94704
About this study
Official title: Reducing Chemical Exposures in Nail Salons Using an Owner-to-Worker Intervention
In this intervention study, the investigators engage Vietnamese American nail salon owners to train workers within their salons on how to reduce workplace chemical exposures. The long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote worker health and safety in this vulnerable worker population.
Read the 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:
- increasing worker knowledge of WCER ii) modifying behavioral and environmental factors that promote WCER
- Conditions
- Occupational Exposure
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Owner-to-Worker training about reducing chemical exposures in nail salons
| Study group | Role | What they receive |
|---|---|---|
| Knowledge and behavioral intervention | Experimental | Owner and worker trainings regarding knowledge and behaviors associated with workplace chemical exposure reduction Receives: Behavioral: Education |
| Delayed intervention | Other | Delayed knowledge and behavioral intervention Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced measured workplace chemicals by air monitoring
Measured: from 4 to 6 months
Secondary outcomes (1)
Behavior and knowledge change by questionnaire
Measured: from 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Sep 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Prevention Institute of California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048630
- Sponsor's protocol ID
- 2012-008
- Acronym
- KHOEDEP
- Status last verified
- Feb 2017
- First submitted
- 31 Jan 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Chemical Exposures in Nail Salons Using an Owner-to-Worker Intervention
- ClinicalTrials.gov ID
- NCT03048630
- Acronym / sponsor ID
- KHOEDEP / 2012-008
- Conditions
- Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Cancer Prevention Institute of CaliforniaUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this intervention study, the investigators engage Vietnamese American nail salon owners to train workers within their salons on how to reduce workplace chemical exposures. The long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote worker health and safety in this vulnerable worker population.
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:
- increasing worker knowledge of WCER ii) modifying behavioral and environmental factors that promote WCER
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knowledge and behavioral intervention | Experimental | Behavioral: EducationOwner and worker trainings regarding knowledge and behaviors associated with workplace chemical exposure reduction |
| Delayed intervention | Other | Behavioral: EducationDelayed knowledge and behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nail salon workers and owners who speak and/or write Vietnamese
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationOwner-to-Worker training about reducing chemical exposures in nail salons | Behavioural | Delayed intervention, Knowledge and behavioral intervention |
Primary outcome
Reduced measured workplace chemicals by air monitoring
Time frame: from 4 to 6 months
1 secondary outcome
Behavior and knowledge change by questionnaire
Time frame: from 4 to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Occupational Exposure, run by Cancer Prevention Institute of California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced measured workplace chemicals by air monitoring (time frame: from 4 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017; AzTrials last refreshed its copy on 30 Oct 2026.