Work-related InjuryNCT04378348
Prevention Program to Reduce Injury Disparities Among Latino Day Laborers
A study testing Motivational Interview (MI) and Participatory Group Activity in people with Work-related Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to Identify intervention priorities using a corner-based needs assessment to document occupational and psychosocial risk and protective factors that increase Latino day laborers(LDL) risk for injury and to design a culturally responsive and context appropriate Occupational Safety and… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Work-related Injury
- What is being tested?
- Motivational Interview (MI) and Participatory Group Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2015to 8 Dec 2015
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Latino
- identified at a "corner" located in the Houston metropolitan area
- currently looking for work at a corner
Who cannot join
- not of Hispanic/Latino background
- being unable to participate in the survey due to alcohol or drug use impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to Identify intervention priorities using a corner-based needs assessment to document occupational and psychosocial risk and protective factors that increase Latino day laborers(LDL) risk for injury and to design a culturally responsive and context appropriate Occupational Safety and Health Administration (OSHA) 10-based safety intervention that also addresses psychosocial risks to reduce LDL injuries and collaboratively pilot a corner-level intervention and conduct an evaluation to assess the safety program's feasibility and acceptability as determined by the extent to which we can recruit, retain and follow-up LDL over the course of the study.
- Conditions
- Work-related Injury
- Being tested
- Motivational Interview (MI), Participatory Group Activity, Control Condition
- Keywords
- latino day laborers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview (MI)Behavioural
The MI dialogue will begin with an introduction where the LDL is asked about the type of work he does and his concerns regarding dangers in his workplace. This will be followed by a decisional balance exercise where the interviewer will engage the LDL in thinking about the pros and cons of taking jobs with many dangers and jobs with less dangers. Using a figure of a traffic light, the interviewer will proceed to measure how important it is for the LDL to reduce the dangers in his work place and identify his reasons for its importance. Next, the interviewer will measure the LDL's level of confidence in his ability to reduce the dangers in his workplace.Together, they will develop a plan to reduce the dangers in the workplace. Finally, the interviewer will summarize the safety plan to the LDL and will explain that the team will return to the corner in one month to see how the implementation of his plan went and to conduct a post-test survey
Participatory Group ActivityBehavioural
Participants will view a figure of a pyramid representing the steps they can take to reduce the dangers in their workplace and the things that are in their control to reduce the dangers followed by pictures of dangerous work environments. They will be engaged in hazard identification and situational awareness by identifying and sharing out loud the dangers they see in the picture. Participants will also engage in problem solving by coming up with strategies they could use to reduce the dangers they identified in the picture and will measure their level of confidence in their ability to implement the strategies they have come up with, should they find themselves in a similar work situation. The group facilitator will summarize what the group has said and what they have learned during the group activity and will ask participants to voluntarily make a personal promise to take concrete steps to reduce the dangers at their work.
Control ConditionBehavioural
At control corner sites, we will recruit another 35 Latino day laborer participants.Participants in the control group will receive OSHA pamphlets with standard workplace safety and health information. During our needs assessment survey, we collected information regarding workrelated injuries. Results from this survey indicate the following 4 categories are the highest cause of injury among surveyed Latino day laborers: 1) moving heavy objects, 2) falls, 3) being struck by falling or lying objects, and 4) serious cuts. The OSHA materials that will be distributed to participants will include safety and health information regarding these four topics. Furthermore, given that the LDL are continuously exposed to the sun (e.g., at the corner while waiting for work, at work, and on their way to and from work), heat exposure will also be included in the OSHA materials.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Experimental | Not described Receives: Behavioral: Motivational Interview (MI) |
| Participatory Group Activity | Experimental | Not described Receives: Behavioral: Participatory Group Activity |
| Control Condition | Placebo comparator | Not described Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to dangers in the workplace as assessed by a questionnaire
The questionnaire asks how often the participant has worked with asbestos, lead paint, Clorox, oil paint, solvents (such as paint thinner), insecticides (such as Raid), glue or adhesive, equipment that creates dust, gasoline or diesel, and cleaning solutions. Each of 10 items on the questionnaire are rated as 1 Never, 2 Sometimes, 3 Many Times, or 4 All the Time, with a total score ranging from 10 to 40, with higher scores indicating greater exposure to dangers in the workplace.
Measured: Baseline
Exposure to dangers in the workplace as assessed by a questionnaire
The questionnaire asks how often the participant has worked with asbestos, lead paint, Clorox, oil paint, solvents (such as paint thinner), insecticides (such as Raid), glue or adhesive, equipment that creates dust, gasoline or diesel, and cleaning solutions. Each of 10 items on the questionnaire are rated as 1 Never, 2 Sometimes, 3 Many Times, or 4 All the Time, with a total score ranging from 10 to 40, with higher scores indicating greater exposure to dangers in the workplace.
Measured: 1 month
Number of participants who had a severe injury or illness in the past month related to their job as a day laborer
Severe injury or illness is defined as an injury or illness where the participant missed work because o the injury or illness, the participant should not have gone to work but you did anyway, or the participant had to receive medical attention from a doctor or a clinic.
Measured: Baseline
Number of participants who had a severe injury or illness in the past month related to their job as a day laborer
Severe injury or illness is defined as an injury or illness where the participant missed work because o the injury or illness, the participant should not have gone to work but you did anyway, or the participant had to receive medical attention from a doctor or a clinic.
Measured: 1 month
Secondary outcomes (5)
Number of participants who had anything happen to them at work in the past month that almost caused them to be injured or made them feel that they could have been injured
Measured: Baseline
Number of participants who had anything happen to them at work in the past month that almost caused them to be injured or made them feel that they could have been injured
Measured: 1 month
Feasibility and acceptability as indicated by number of participants recruited to the study
Measured: Baseline
Feasibility and acceptability as indicated by number of participants retained in the study
Measured: 1 month
Feasibility and acceptability as indicated by number of participants who completed the one month follow up
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start26 Oct 2015
- Primary completion3 Nov 2015
- Study completion8 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work-related InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria E Fernandez-Esquer, The University of Texas Health Science Center, Houston
- Investigators
- Maria Fernandez-Esquer, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378348
- Sponsor's protocol ID
- HSC-SPH-12-0818
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-Esquer ME, Atkinson JS, Hernandez RA, Aguerre CF, Brown LD, Reininger B, Ojeda MA, Field C, Rhoton JM, Da Silva CE, Diamond PM. Vales+Tu: a cluster-randomized pilot study to reduce workplace injuries among US Latino day laborers. Health Promot Int. 2022 Dec 1;37(6):daac163. doi: 10.1093/heapro/daac163.
PubMed 36367426
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Program to Reduce Injury Disparities Among Latino Day Laborers
- ClinicalTrials.gov ID
- NCT04378348
- Acronym / sponsor ID
- HSC-SPH-12-0818
- Conditions
- Work-related Injury
- Keywords
- latino day laborers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- 3 Nov 2015 (actual)
- Study completion
- 8 Dec 2015 (actual)
- First posted
- 7 May 2020 (actual)
- 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.
The purpose of this study is to Identify intervention priorities using a corner-based needs assessment to document occupational and psychosocial risk and protective factors that increase Latino day laborers(LDL) risk for injury and to design a culturally responsive and context appropriate Occupational Safety and Health Administration (OSHA) 10-based safety intervention that also addresses psychosocial risks to reduce LDL injuries and collaboratively pilot a corner-level intervention and conduct an evaluation to assess the safety program's feasibility and acceptability as determined by the extent to which we can recruit, retain and follow-up LDL over the course of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Experimental | Behavioral: Motivational Interview (MI) |
| Participatory Group Activity | Experimental | Behavioral: Participatory Group Activity |
| Control Condition | Placebo comparator | Behavioral: Control Condition |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Latino
- identified at a "corner" located in the Houston metropolitan area
- currently looking for work at a corner
Key exclusion criteria (2 listed)
- not of Hispanic/Latino background
- being unable to participate in the survey due to alcohol or drug use impairment.
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 |
|---|---|---|
| Motivational Interview (MI)The MI dialogue will begin with an introduction where the LDL is asked about the type of work he does and his concerns regarding dangers in his workplace. This will be followed by a decisional balance exercise where the interviewer will engage the LDL in thinking about the pros and cons of taking jobs with many dangers and jobs with less dangers. Using a figure of a traffic light, the interviewer will proceed to measure how important it is for the LDL to reduce the dangers in his work place and identify his reasons for its importance. Next, the interviewer will measure the LDL's level of confidence in his ability to reduce the dangers in his workplace.Together, they will develop a plan to reduce the dangers in the workplace. Finally, the interviewer will summarize the safety plan to the LDL and will explain that the team will return to the corner in one month to see how the implementation of his plan went and to conduct a post-test survey | Behavioural | Motivational Interview |
| Participatory Group ActivityParticipants will view a figure of a pyramid representing the steps they can take to reduce the dangers in their workplace and the things that are in their control to reduce the dangers followed by pictures of dangerous work environments. They will be engaged in hazard identification and situational awareness by identifying and sharing out loud the dangers they see in the picture. Participants will also engage in problem solving by coming up with strategies they could use to reduce the dangers they identified in the picture and will measure their level of confidence in their ability to implement the strategies they have come up with, should they find themselves in a similar work situation. The group facilitator will summarize what the group has said and what they have learned during the group activity and will ask participants to voluntarily make a personal promise to take concrete steps to reduce the dangers at their work. | Behavioural | Participatory Group Activity |
| Control ConditionAt control corner sites, we will recruit another 35 Latino day laborer participants.Participants in the control group will receive OSHA pamphlets with standard workplace safety and health information. During our needs assessment survey, we collected information regarding workrelated injuries. Results from this survey indicate the following 4 categories are the highest cause of injury among surveyed Latino day laborers: 1) moving heavy objects, 2) falls, 3) being struck by falling or lying objects, and 4) serious cuts. The OSHA materials that will be distributed to participants will include safety and health information regarding these four topics. Furthermore, given that the LDL are continuously exposed to the sun (e.g., at the corner while waiting for work, at work, and on their way to and from work), heat exposure will also be included in the OSHA materials. | Behavioural | Control Condition |
Primary outcome
Exposure to dangers in the workplace as assessed by a questionnaire
Time frame: Baseline
The questionnaire asks how often the participant has worked with asbestos, lead paint, Clorox, oil paint, solvents (such as paint thinner), insecticides (such as Raid), glue or adhesive, equipment that creates dust, gasoline or diesel, and cleaning solutions. Each of 10 items on the questionnaire are rated as 1 Never, 2 Sometimes, 3 Many Times, or 4 All the Time, with a total score ranging from 10 to 40, with higher scores indicating greater exposure to dangers in the workplace.
Exposure to dangers in the workplace as assessed by a questionnaire
Time frame: 1 month
The questionnaire asks how often the participant has worked with asbestos, lead paint, Clorox, oil paint, solvents (such as paint thinner), insecticides (such as Raid), glue or adhesive, equipment that creates dust, gasoline or diesel, and cleaning solutions. Each of 10 items on the questionnaire are rated as 1 Never, 2 Sometimes, 3 Many Times, or 4 All the Time, with a total score ranging from 10 to 40, with higher scores indicating greater exposure to dangers in the workplace.
Number of participants who had a severe injury or illness in the past month related to their job as a day laborer
Time frame: Baseline
Severe injury or illness is defined as an injury or illness where the participant missed work because o the injury or illness, the participant should not have gone to work but you did anyway, or the participant had to receive medical attention from a doctor or a clinic.
Number of participants who had a severe injury or illness in the past month related to their job as a day laborer
Time frame: 1 month
Severe injury or illness is defined as an injury or illness where the participant missed work because o the injury or illness, the participant should not have gone to work but you did anyway, or the participant had to receive medical attention from a doctor or a clinic.
5 secondary outcomes
Number of participants who had anything happen to them at work in the past month that almost caused them to be injured or made them feel that they could have been injured
Time frame: Baseline
Number of participants who had anything happen to them at work in the past month that almost caused them to be injured or made them feel that they could have been injured
Time frame: 1 month
Feasibility and acceptability as indicated by number of participants recruited to the study
Time frame: Baseline
Feasibility and acceptability as indicated by number of participants retained in the study
Time frame: 1 month
Feasibility and acceptability as indicated by number of participants who completed the one month follow up
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Derived from this study: PubMed 36367426Fernandez-Esquer ME, Atkinson JS, Hernandez RA, Aguerre CF, Brown LD, Reininger B, Ojeda MA, Field C, Rhoton JM, Da Silva CE, Diamond PM. Vales+Tu: a cluster-randomized pilot study to reduce workplace injuries among US Latino day laborers. Health Promot Int. 2022 Dec 1;37(6):daac163. doi: 10.1093/heapro/daac163.
- 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.
Maria Fernandez-Esquer, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview (MI) and Participatory Group Activity in people with Work-related Injury, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 May 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exposure to dangers in the workplace as assessed by a questionnaire (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04378348, which also lists 1 linked publication.
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 7 May 2020.