NCT04800757

Brief Summary

The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 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

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

March 11, 2021

Results QC Date

November 2, 2022

Last Update Submit

December 3, 2022

Conditions

Keywords

latino day laborers

Outcome Measures

Primary Outcomes (2)

  • Change in Work Hazard Exposure as Assessed by a Survey

    Total score on the work hazard exposure survey ranges from 1 - 4, with a higher score indicating greater work hazard exposures. The data are reported as score at post-intervention minus score at baseline.

    Baseline, 4 weeks post intervention

  • Change in Work Conditions as Assessed by a Survey

    Total score on the work conditions survey ranges from 1 - 4, with a higher score indicating greater adverse work conditions. The data are reported as score at post-intervention minus score at baseline.

    Baseline, 4 weeks post intervention

Secondary Outcomes (2)

  • Change in Safety Practices as Assessed by a Survey

    Baseline, 4 weeks post intervention

  • Number of Participants That Implemented the Safety Plan as Assessed by a Survey

    4 weeks post intervention

Study Arms (3)

individual (Brief Motivational Intervention)

EXPERIMENTAL
Behavioral: individual -Brief Motivational Intervention (BMI)

Group (Group Problem Solving)

EXPERIMENTAL
Behavioral: Group (Group Problem Solving)

Standard of Care

PLACEBO COMPARATOR
Behavioral: Standard of Care (OSHA 10 Safety Cards)

Interventions

A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge ("Mi Promesa") to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey.

individual (Brief Motivational Intervention)

Participants will be administered a baseline survey prior to session. The GPS intervention consists of a discussion between 2-5 LDLs and a trained group facilitator. The sessions will last 30-45 minutes and are intended to encourage and support Latino day laborers (LDL) to act to reduce work-related hazards and promote worksite safety. The intervention combines four participatory and group problem solving activities to engage in collaborative learning: an icebreaker, the risk identification, action planning, and Nuestra Promesa (Our Pledge). The last activity requires LDL to select a risk reduction behavior and then to fill out and sign a card detailing a pledge to implement a safety plan. Follow up surveys will be conducted four weeks post intervention, to assess participants' change in attitudes, beliefs, and risk reducing behavior and their implementation or their safety plan.

Group (Group Problem Solving)

Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy.

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-identify as Hispanic or Latino
  • be present at the corner for the purpose of looking for work

You may not qualify if:

  • have not been previously hired to work at a corner
  • symptoms of COVID-19 in the previous 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Population GroupsStandard of Care

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Maria Eugenia Fernandez-Esquer
Organization
The University of Texas Health Science Center at Houston

Study Officials

  • Maria Eugenia Fernandez-Esquer, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

May 11, 2021

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

December 23, 2022

Results First Posted

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations