Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06411769
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012574', 'term': 'Schools'}], 'ancestors': [{'id': 'D000072182', 'term': 'Non-Medical Public and Private Facilities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study will draw upon Sequential, Multiple Assignment, Randomized Trials (SMART) design to reduce barriers for both individuals and worksites to improve responsiveness to individual performance. The investigators are using the Consolidated Framework for Implementation Research (CFIR) across all project activities to establish proof-of-concept and improve the quality of behavioral intervention delivery to disparate populations on the U.S.-Mexico border and other similar regions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 406}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Step Count', 'timeFrame': 'Daily, Weekly up to 18 months.', 'description': 'The Pathverse app synced with an activity tracker will be used to collect daily step counts. The goal is for teams (schools) to have 50% of their staff with an average weekly steps \\> 50,000.'}], 'secondaryOutcomes': [{'measure': 'Cardiorespiratory Fitness (CVF)', 'timeFrame': 'Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.', 'description': 'The heart rate/minute at the end of the YMCA 3-minute submaximal bench-stepping test will be used to assess the level of CVF associated with increased PA.'}, {'measure': 'Weight', 'timeFrame': 'Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.', 'description': 'Weight (to the nearest 0.1 kg) will be collected using a portable scale'}, {'measure': 'Height', 'timeFrame': 'Baseline', 'description': 'Height (measured to the nearest 0.1 cm) will be obtained using a stadiometer.'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.', 'description': 'Body Mass Index (BMI) will be calculated as weight (kg)/height squared (m2).'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.', 'description': 'Waist circumference will be measured at the midway between the iliac crests and the lower ribs.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Walking Challenge', 'Moderate-to-Vigorous-Physical Activity', 'Evidence-based', 'Employer-based'], 'conditions': ['Activity Trackers', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '3128514', 'type': 'BACKGROUND', 'citation': 'Hourdou ML, Besson F, Michel G. 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A qualitative study of facilitators and barriers to implementing worksite policies that support physical activity. BMC Public Health. 2018 Sep 27;18(1):1145. doi: 10.1186/s12889-018-6045-x.'}, {'pmid': '31624537', 'type': 'BACKGROUND', 'citation': 'Garne-Dalgaard A, Mann S, Bredahl TVG, Stochkendahl MJ. Implementation strategies, and barriers and facilitators for implementation of physical activity at work: a scoping review. Chiropr Man Therap. 2019 Oct 9;27:48. doi: 10.1186/s12998-019-0268-5. eCollection 2019.'}, {'pmid': '31336749', 'type': 'BACKGROUND', 'citation': 'Sedani A, Stover D, Coyle B, Wani RJ. Assessing Workplace Health and Safety Strategies, Trends, and Barriers through a Statewide Worksite Survey. Int J Environ Res Public Health. 2019 Jul 11;16(14):2475. doi: 10.3390/ijerph16142475.'}, {'pmid': '28529961', 'type': 'BACKGROUND', 'citation': 'Wu S, Fisher-Hoch SP, Reninger B, McCormick JB. Meeting or Exceeding Physical Activity Guidelines is Associated with Reduced Risk for Cancer in Mexican-Americans. Am J Cancer Prev. 2016;4(1):1-7. doi: 10.12691/ajcp-4-1-1. Epub 2016 Jan 29.'}, {'pmid': '33345634', 'type': 'BACKGROUND', 'citation': 'Salinas JJ, Valenzuela R, Sheen J, Carlyle M, Gay J, Morales A. An ORBIT Phase 1: Design study of a citywide employer-based walking challenges in a predominantly Mexican American metropolitan area. J Health Psychol. 2022 Mar;27(4):961-973. doi: 10.1177/1359105320977650. Epub 2020 Dec 20.'}, {'pmid': '34886463', 'type': 'BACKGROUND', 'citation': 'Saadiq S, Valenzuela R, Wang J, Yin Z, Parra-Medina D, Gay J, Salinas JJ. Walking Engagement in Mexican Americans Who Participated in a Community-Wide Step Challenge in El Paso, TX. Int J Environ Res Public Health. 2021 Dec 2;18(23):12738. doi: 10.3390/ijerph182312738.'}, {'pmid': '30286595', 'type': 'BACKGROUND', 'citation': 'Salinas JJ, McDaniel M, Parra-Medina D. The Role of Social Support and the Neighborhood Environment on Physical Activity in Low-income, Mexican-American Women in South Texas. J Prev Med Public Health. 2018 Sep;51(5):234-241. doi: 10.3961/jpmph.18.052. Epub 2018 Jul 25.'}, {'pmid': '21731409', 'type': 'BACKGROUND', 'citation': 'Parra-Medina D, Hilfinger Messias DK. Promotion of Physical Activity Among Mexican-Origin Women in Texas and South Carolina: An Examination of Social, Cultural, Economic, and Environmental Factors. Quest. 2011 Feb;63(1):100-117. doi: 10.1080/00336297.2011.10483668.'}, {'pmid': '31092399', 'type': 'BACKGROUND', 'citation': 'Mitchell MS, Orstad SL, Biswas A, Oh PI, Jay M, Pakosh MT, Faulkner G. Financial incentives for physical activity in adults: systematic review and meta-analysis. Br J Sports Med. 2020 Nov;54(21):1259-1268. doi: 10.1136/bjsports-2019-100633. Epub 2019 May 15.'}, {'pmid': '19359291', 'type': 'BACKGROUND', 'citation': 'Marteau TM, Ashcroft RE, Oliver A. Using financial incentives to achieve healthy behaviour. BMJ. 2009 Apr 9;338:b1415. doi: 10.1136/bmj.b1415. No abstract available.'}, {'pmid': '27750317', 'type': 'BACKGROUND', 'citation': 'Weinstock J, Petry NM. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults. Ann Intern Med. 2016 Oct 18;165(8):599. doi: 10.7326/L16-0281. No abstract available.'}, {'pmid': '28593067', 'type': 'BACKGROUND', 'citation': 'Meng L, Wolff MB, Mattick KA, DeJoy DM, Wilson MG, Smith ML. Strategies for Worksite Health Interventions to Employees with Elevated Risk of Chronic Diseases. Saf Health Work. 2017 Jun;8(2):117-129. doi: 10.1016/j.shaw.2016.11.004. Epub 2016 Dec 2.'}, {'pmid': '23597820', 'type': 'BACKGROUND', 'citation': 'Mehta S, Dimsdale J, Nagle B, Holub CK, Woods C, Barquera S, Elder JP. Worksite interventions: improving lifestyle habits among Latin American adults. Am J Prev Med. 2013 May;44(5):538-42. doi: 10.1016/j.amepre.2013.01.015.'}, {'pmid': '34366306', 'type': 'BACKGROUND', 'citation': 'Chandrasekaran B, Rao CR, Davis F, Arumugam A. SMART STEP - SMARTphone-driven exercise and pedometer-based STEP intervention to promote physical activity among desk-based employees: Study protocol for a three-arm cluster randomized controlled trial. Work. 2021;69(4):1229-1245. doi: 10.3233/WOR-213544.'}, {'pmid': '32700325', 'type': 'BACKGROUND', 'citation': 'Freak-Poli R, Cumpston M, Albarqouni L, Clemes SA, Peeters A. Workplace pedometer interventions for increasing physical activity. Cochrane Database Syst Rev. 2020 Jul 21;7(7):CD009209. doi: 10.1002/14651858.CD009209.pub3.'}, {'pmid': '30480770', 'type': 'BACKGROUND', 'citation': 'Wolfenden L, Goldman S, Stacey FG, Grady A, Kingsland M, Williams CM, Wiggers J, Milat A, Rissel C, Bauman A, Farrell MM, Legare F, Ben Charif A, Zomahoun HTV, Hodder RK, Jones J, Booth D, Parmenter B, Regan T, Yoong SL. Strategies to improve the implementation of workplace-based policies or practices targeting tobacco, alcohol, diet, physical activity and obesity. Cochrane Database Syst Rev. 2018 Nov 14;11(11):CD012439. doi: 10.1002/14651858.CD012439.pub2.'}, {'pmid': '28800736', 'type': 'BACKGROUND', 'citation': 'Stephenson A, McDonough SM, Murphy MH, Nugent CD, Mair JL. Using computer, mobile and wearable technology enhanced interventions to reduce sedentary behaviour: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2017 Aug 11;14(1):105. doi: 10.1186/s12966-017-0561-4.'}, {'pmid': '35060913', 'type': 'BACKGROUND', 'citation': 'Jung J, Cho I. Promoting Physical Activity and Weight Loss With mHealth Interventions Among Workers: Systematic Review and Meta-analysis of Randomized Controlled Trials. 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Prev Sci. 2019 Nov;20(8):1211-1218. doi: 10.1007/s11121-019-01043-z.'}, {'pmid': '22536058', 'type': 'BACKGROUND', 'citation': 'Wang J, Sereika SM, Chasens ER, Ewing LJ, Matthews JT, Burke LE. Effect of adherence to self-monitoring of diet and physical activity on weight loss in a technology-supported behavioral intervention. Patient Prefer Adherence. 2012;6:221-6. doi: 10.2147/PPA.S28889. Epub 2012 Mar 22.'}, {'pmid': '30049667', 'type': 'BACKGROUND', 'citation': "Wang J, Chu CF, Li C, Hayes L, Siminerio L. Diabetes Educators' Insights Regarding Connecting Mobile Phone- and Wearable Tracker-Collected Self-Monitoring Information to a Nationally-Used Electronic Health Record System for Diabetes Education: Descriptive Qualitative Study. JMIR Mhealth Uhealth. 2018 Jul 26;6(7):e10206. doi: 10.2196/10206."}, {'pmid': '34623603', 'type': 'BACKGROUND', 'citation': 'Valenzuela R, Morales A, Sheen J, Rangel S, Salinas JJ. The Implementation of Evidence-Based Obesity Education Curricula to Prevent Cancer in a Predominantly Mexican-American Community on the U.S.-Mexico Border. J Cancer Educ. 2023 Feb;38(1):215-224. doi: 10.1007/s13187-021-02101-3. Epub 2021 Oct 8.'}, {'pmid': '29636320', 'type': 'BACKGROUND', 'citation': 'Wang J, Cai C, Padhye N, Orlander P, Zare M. A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial. JMIR Mhealth Uhealth. 2018 Apr 10;6(4):e92. doi: 10.2196/mhealth.4478.'}, {'pmid': '3432232', 'type': 'BACKGROUND', 'citation': 'Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.'}, {'pmid': '28005532', 'type': 'BACKGROUND', 'citation': 'Ramirez M, Wu S, Beale E. Designing a Text Messaging Intervention to Improve Physical Activity Behavior Among Low-Income Latino Patients With Diabetes: A Discrete-Choice Experiment, Los Angeles, 2014-2015. Prev Chronic Dis. 2016 Dec 22;13:E171. doi: 10.5888/pcd13.160035.'}, {'pmid': '26678750', 'type': 'BACKGROUND', 'citation': 'Morton K, Sutton S, Hardeman W, Troughton J, Yates T, Griffin S, Davies M, Khunti K, Eborall H. A Text-Messaging and Pedometer Program to Promote Physical Activity in People at High Risk of Type 2 Diabetes: The Development of the PROPELS Follow-On Support Program. JMIR Mhealth Uhealth. 2015 Dec 15;3(4):e105. doi: 10.2196/mhealth.5026.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will test if the 50,000 for Life (50K4Life) is effective at improving walking engagement in school employees in 30 public schools by delivering a two-phased adaptive intervention to improve walking engagement in school workers in 30 public schools. In Phase 1, all study schools will be randomly assigned to a 50K4Life only, or 50K4Life + SMS Text Messaging group.\n\nIn Phase 2, non-responder schools will be randomly assigned to one of two 6-month adaptive treatments: a) an individual-level intervention that includes remote education modules (REM) and one-to-one monthly phone-based coaching, or, b) a school-level intervention that includes group educational sessions, school environmental modifications (floor distance markings, signage in corridors and breakrooms, promotional items), and work time/weekend group walks/hikes. The schools that 50% or more participants who achieve 50,000 steps in one week will continue with the Phase 1 condition. Intervention strategies will be coordinated by health educators and managed using the Pathverse app. Data collection will occur at baseline, 8 weeks (Phase 2 randomization decision point), 8 months (immediate post intervention), 12 months (4 months post-intervention), and 18 months (10 months post-intervention) for a total of 18 months of study participation.', 'detailedDescription': "Mexican Americans who live in the U.S.-Mexico border region suffer disproportionately from preventable cardiometabolic diseases. Regular brisk walking is an effective measure in regulating metabolic processes and preventing disease. Employer-based wellness programs are promising strategies to address this public health problem because of the opportunity to take advantage of workplace environments to improve opportunities for walking engagement while also addressing barriers associated with inactivity. Employer-based walking programs have not been widely tested on the U.S.-Mexico border. A clustered Sequential Multiple Assignment Randomized Trial (SMART) will be conducted to determine the effectiveness of an employer-based walking challenge intervention- 50,000 for Life (50K4Life)- in improving brisk walking engagement (at least 7,000 steps/day) among school district employees. The proposed intervention strategies are based on the walking interventions conducted by the Principal Investigator(s) in El Paso and behavioral, environmental and worksite interventions by the Co-Investigators. The trial will include 30 randomly selected public schools with predominantly Mexican American employees from El Paso County area school districts. The intervention strategies in 50K4Life will be in two phases: 1) 50K4Life vs. 50K4Life + SMS text messaging and 2) Individual vs. School level adaptation for campuses with a low response to the initial intervention phase. The investigators hypothesize that walking challenges with multilevel capacity building and adaptations based on intervention response will lead to improved adherence to PA guidelines. This proposed socioecological model-based study leverages resources through Hispanic Serving Institutions (HSI) from Texas and expertise in employer-based workplace interventions from the University of Georgia (UGA) based on the partner's accumulative work to address the disparity in PA and advance health equity in the Mexican American population. As part of the intervention evaluation, the PIs will conduct a process evaluation and cost-effectiveness to provide insight into cost and scalability. This study will provide needed information on optimizing the implementation of evidence-based behavioral interventions to improve walking engagement among Mexican Americans living in the U.S.-Mexico border region."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A school is eligible if it is located within one of the four target school districts\n* adult 18 years or older\n* full-time school-based school district employee\n* not pregnant and able to walk without physical limitations or assistive device\n* willing to wear our Fitbit tracking device or use their own tracking device for 18 months\n* own a smartphone\n* willingness to use a personal smartphone for tracking activity related to the Fitbit tracker, access online intervention content, and receive text messages.\n\nExclusion Criteria:\n\n* Works at more than one school\n* Does not work on a district school campus\n* schools that previously participated in walking challenges'}, 'identificationModule': {'nctId': 'NCT06411769', 'briefTitle': 'Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas, El Paso'}, 'officialTitle': 'Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas', 'orgStudyIdInfo': {'id': 'U01MD019289', 'link': 'https://reporter.nih.gov/quickSearch/U01MD019289', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '7U01MD019289-02', 'link': 'https://reporter.nih.gov/quickSearch/7U01MD019289-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1. 50K4LIfe Only', 'description': 'Walking Challenge only', 'interventionNames': ['Behavioral: 50K4LIfe']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1. 50K4Life + SMS Text Messages', 'description': 'Walking Challenge + SMS Messages', 'interventionNames': ['Behavioral: 50K4LIfe', 'Behavioral: SMS Text Messaging']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2. 50K4LIfe + Individual', 'description': 'Walking Challenge + Individual level interventions.', 'interventionNames': ['Behavioral: 50K4LIfe', 'Behavioral: Individual']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2. 50K4LIfe + School', 'description': 'Walking Challenge + School-level interventions', 'interventionNames': ['Behavioral: 50K4LIfe', 'Behavioral: School']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2. 50K4Life + SMS Text Messages + Individual', 'description': 'Walking Challenge + SMS Messages + Individual level interventions', 'interventionNames': ['Behavioral: 50K4LIfe', 'Behavioral: SMS Text Messaging', 'Behavioral: Individual']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2. 50K4Life + SMS Text Messages + Schools', 'description': 'Walking Challenge + SMS Messages + School-level interventions', 'interventionNames': ['Behavioral: 50K4LIfe', 'Behavioral: SMS Text Messaging', 'Behavioral: School']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2. Walking Challenge only', 'description': 'Participants meeting the step goal in Phase 1(WC only) will continue into Phase 2 without change.', 'interventionNames': ['Behavioral: 50K4LIfe']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2. Walking Challenge + SMS Text Messages', 'description': 'Participants meeting their step goal in Phase 1 (WC + SMS Text Messages) will continue into Phase 2 without change.', 'interventionNames': ['Behavioral: 50K4LIfe', 'Behavioral: SMS Text Messaging']}], 'interventions': [{'name': '50K4LIfe', 'type': 'BEHAVIORAL', 'description': 'This intervention will consist of the Walking Challenge only.', 'armGroupLabels': ['Phase 1. 50K4LIfe Only', 'Phase 1. 50K4Life + SMS Text Messages', 'Phase 2. 50K4LIfe + Individual', 'Phase 2. 50K4LIfe + School', 'Phase 2. 50K4Life + SMS Text Messages + Individual', 'Phase 2. 50K4Life + SMS Text Messages + Schools', 'Phase 2. Walking Challenge + SMS Text Messages', 'Phase 2. Walking Challenge only']}, {'name': 'SMS Text Messaging', 'type': 'BEHAVIORAL', 'description': 'In this intervention, participants will received notifications onto the Pathverse app', 'armGroupLabels': ['Phase 1. 50K4Life + SMS Text Messages', 'Phase 2. 50K4Life + SMS Text Messages + Individual', 'Phase 2. 50K4Life + SMS Text Messages + Schools', 'Phase 2. Walking Challenge + SMS Text Messages']}, {'name': 'Individual', 'type': 'BEHAVIORAL', 'description': 'In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.', 'armGroupLabels': ['Phase 2. 50K4LIfe + Individual', 'Phase 2. 50K4Life + SMS Text Messages + Individual']}, {'name': 'School', 'type': 'BEHAVIORAL', 'description': 'In this Phase 2 school-level intervention, participants will receive group educational sessions, school environmental modifications (floor distance markings, signage in corridors and breakrooms, promotional items), and participate in work time/weekend group walks/hikes.', 'armGroupLabels': ['Phase 2. 50K4LIfe + School', 'Phase 2. 50K4Life + SMS Text Messages + Schools']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79968', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaycee Carmagnani, MSW', 'role': 'CONTACT', 'email': 'kkcarmagnani2@utep.edu', 'phone': '915-747-8349'}, {'name': 'Jennifer J Salinas, Ph.D., LMSW', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas at El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '79968', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Salinas, MSW', 'role': 'CONTACT', 'email': 'jsalinas7@utep.edu', 'phone': '915-747-7292'}, {'name': 'Jennifer J Salinas, Ph.D., LMSW', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas at El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'centralContacts': [{'name': 'Jennifer J Salinas, Ph.D.,LMSW', 'role': 'CONTACT', 'email': 'jsalinas7@utep.edu', 'phone': '915-747-7292'}, {'name': 'Kaycee Carmagnani, MSW', 'role': 'CONTACT', 'email': 'kkcarmagnani2@utep.edu', 'phone': '915-747-8349'}], 'overallOfficials': [{'name': 'Jennifer J Salinas, Ph.D., LMSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, El Paso'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas, El Paso', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}