Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 6:13 AM
Study NCT ID:
NCT04800757
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Maria.E.Fernandez-Esquer@uth.tmc.edu', 'phone': '(713) 500-9657', 'title': 'Maria Eugenia Fernandez-Esquer', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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.", 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan.", 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Work Hazard Exposure as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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."}, {'id': 'OG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.'}, {'id': 'OG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks post intervention', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Work Conditions as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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."}, {'id': 'OG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.'}, {'id': 'OG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '0.59', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks post intervention', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Safety Practices as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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."}, {'id': 'OG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.'}, {'id': 'OG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan."}], 'classes': [{'title': 'Safety Practices: All Items', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.53', 'groupId': 'OG002'}]}]}, {'title': 'Safety Practices: Preparation Safety', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.73', 'groupId': 'OG002'}]}]}, {'title': 'Safety Practices: Harm Mitigation', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.64', 'groupId': 'OG002'}]}]}, {'title': 'Safety Practices: Proactive Communication', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks post intervention', 'description': 'The score for each of the 22 safety practices items ranged from 1-4, with a higher score indicating greater safety practice. The total score for the complete scale consisting of all 22 items is the average of items responded to and also ranged from 1-4. Separate scores for each subscale were computed similarly. The first subscale consisted of eight items; the second consisted of four items, and the third consisted of three items--the score for each subscale ranged from 1-4, with a higher score indicating greater safety practice. There were seven original items that were not associated with the subscales derived from the factor analyses. The data are reported as scores at post-intervention minus scores at baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Implemented the Safety Plan as Assessed by a Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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."}, {'id': 'OG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.'}, {'id': 'OG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan."}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}, {'title': 'Partially', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post intervention', 'description': 'Participants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants in the standard of care arm did not make a safety plan; therefore, safety plan data were not collected for the standard of care arm. Also, data for this outcome measure were not collected from 34/82 participants in the Brief Motivational Intervention arm and 34/75 participants in the Group Problem Solving arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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."}, {'id': 'FG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.'}, {'id': 'FG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participants will be administered a baseline survey prior to the session. The group problem solving intervention will consist of a discussion between 2-5 LDLs and a lay health promoter trained as a group facilitator. The sessions are expected to last 30-45 minutes and are intended to encourage and support Latino day laborers (LDL) to take action to reduce work-related hazards and promote worksite safety for themselves and their co-workers. 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 each 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 over the phone, four weeks post intervention, to assess participants' change in attitudes, beliefs, and risk reducing behavior and their implementation or their safety plan."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '113'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '102'}, {'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '110'}]}, {'type': 'Completed Baseline Assessment', 'achievements': [{'comment': 'One subject did not complete baseline survey', 'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '112'}, {'comment': '2 subjects did not complete baseline survey', 'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '100'}, {'comment': '4 subjects did not complete baseline survey', 'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '106'}]}, {'type': 'Completed Post-Intervention Assessment', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '91'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '82'}, {'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '91'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '82'}, {'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '22'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '20'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '35'}]}]}], 'typeUnitsAnalyzed': 'corners'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': "Standard of Care (OSHA 10 Safety Cards): 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."}, {'id': 'BG001', 'title': 'Individual (Brief Motivational Intervention)', 'description': 'individual -Brief Motivational Intervention (BMI): 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.'}, {'id': 'BG002', 'title': 'Group (Group Problem Solving)', 'description': "Group (Group Problem Solving): Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '317', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '46', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '45.6', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age was not collected for one participant in the BMI arm.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline data are reported for the 318 participants who completed the baseline assessment. Age was not collected for one participant in the BMI arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-15', 'size': 505269, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-12T15:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-03', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-03', 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Work Hazard Exposure as Assessed by a Survey', 'timeFrame': 'Baseline, 4 weeks post intervention', 'description': '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.'}, {'measure': 'Change in Work Conditions as Assessed by a Survey', 'timeFrame': 'Baseline, 4 weeks post intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Safety Practices as Assessed by a Survey', 'timeFrame': 'Baseline, 4 weeks post intervention', 'description': 'The score for each of the 22 safety practices items ranged from 1-4, with a higher score indicating greater safety practice. The total score for the complete scale consisting of all 22 items is the average of items responded to and also ranged from 1-4. Separate scores for each subscale were computed similarly. The first subscale consisted of eight items; the second consisted of four items, and the third consisted of three items--the score for each subscale ranged from 1-4, with a higher score indicating greater safety practice. There were seven original items that were not associated with the subscales derived from the factor analyses. The data are reported as scores at post-intervention minus scores at baseline.'}, {'measure': 'Number of Participants That Implemented the Safety Plan as Assessed by a Survey', 'timeFrame': '4 weeks post intervention', 'description': 'Participants were asked if they implemented the safety plan and they were asked to answer as yes, no or partially'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['latino day laborers'], 'conditions': ['Work-related Injury']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-identify as Hispanic or Latino\n* be present at the corner for the purpose of looking for work\n\nExclusion Criteria:\n\n* have not been previously hired to work at a corner\n* symptoms of COVID-19 in the previous 48 hours'}, 'identificationModule': {'nctId': 'NCT04800757', 'briefTitle': 'VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities', 'orgStudyIdInfo': {'id': 'HSC-SPH-18-0337'}, 'secondaryIdInfos': [{'id': '1R01MD012928', 'link': 'https://reporter.nih.gov/quickSearch/1R01MD012928', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'individual (Brief Motivational Intervention)', 'interventionNames': ['Behavioral: individual -Brief Motivational Intervention (BMI)']}, {'type': 'EXPERIMENTAL', 'label': 'Group (Group Problem Solving)', 'interventionNames': ['Behavioral: Group (Group Problem Solving)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Behavioral: Standard of Care (OSHA 10 Safety Cards)']}], 'interventions': [{'name': 'individual -Brief Motivational Intervention (BMI)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['individual (Brief Motivational Intervention)']}, {'name': 'Group (Group Problem Solving)', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Group (Group Problem Solving)']}, {'name': 'Standard of Care (OSHA 10 Safety Cards)', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Maria Eugenia Fernandez-Esquer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maria Eugenia Fernandez-Esquer', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}