- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06411769
Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas
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.
In 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer J Salinas, Ph.D.,LMSW
- Phone Number: 915-747-7292
- Email: jsalinas7@utep.edu
Study Contact Backup
- Name: Kaycee Carmagnani, MSW
- Phone Number: 915-747-8349
- Email: kkcarmagnani2@utep.edu
Study Locations
-
-
Texas
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El Paso, Texas, United States, 79968
- Recruiting
- University of Texas at El Paso
-
Principal Investigator:
- Jennifer J Salinas, Ph.D., LMSW
-
Contact:
- Jennifer Salinas, MSW
- Phone Number: 915-747-7292
- Email: jsalinas7@utep.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A school is eligible if it is located within one of the four target school districts
- adult 18 years or older
- full-time school-based school district employee
- not pregnant and able to walk without physical limitations or assistive device
- willing to wear our Fitbit tracking device or use their own tracking device for 18 months
- own a smartphone
- willingness to use a personal smartphone for tracking activity related to the Fitbit tracker, access online intervention content, and receive text messages.
Exclusion Criteria:
- Works at more than one school
- Does not work on a district school campus
- schools that previously participated in walking challenges
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase 1. 50K4LIfe Only
Walking Challenge only
|
This intervention will consist of the Walking Challenge only.
|
|
Experimental: Phase 1. 50K4Life + SMS Text Messages
Walking Challenge + SMS Messages
|
This intervention will consist of the Walking Challenge only.
In this intervention, participants will received notifications onto the Pathverse app
|
|
Experimental: Phase 2. 50K4LIfe + Individual
Walking Challenge + Individual level interventions.
|
This intervention will consist of the Walking Challenge only.
In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.
|
|
Experimental: Phase 2. 50K4LIfe + School
Walking Challenge + School-level interventions
|
This intervention will consist of the Walking Challenge only.
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.
|
|
Experimental: Phase 2. 50K4Life + SMS Text Messages + Individual
Walking Challenge + SMS Messages + Individual level interventions
|
This intervention will consist of the Walking Challenge only.
In this intervention, participants will received notifications onto the Pathverse app
In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.
|
|
Experimental: Phase 2. 50K4Life + SMS Text Messages + Schools
Walking Challenge + SMS Messages + School-level interventions
|
This intervention will consist of the Walking Challenge only.
In this intervention, participants will received notifications onto the Pathverse app
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.
|
|
Experimental: Phase 2. Walking Challenge only
Participants meeting the step goal in Phase 1(WC only) will continue into Phase 2 without change.
|
This intervention will consist of the Walking Challenge only.
|
|
Experimental: Phase 2. Walking Challenge + SMS Text Messages
Participants meeting their step goal in Phase 1 (WC + SMS Text Messages) will continue into Phase 2 without change.
|
This intervention will consist of the Walking Challenge only.
In this intervention, participants will received notifications onto the Pathverse app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Step Count
Time Frame: Daily, Weekly up to 18 months.
|
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.
|
Daily, Weekly up to 18 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory Fitness (CVF)
Time Frame: Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.
|
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.
|
Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.
|
|
Weight
Time Frame: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
|
Weight (to the nearest 0.1 kg) will be collected using a portable scale
|
Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
|
|
Height
Time Frame: Baseline
|
Height (measured to the nearest 0.1 cm) will be obtained using a stadiometer.
|
Baseline
|
|
Body Mass Index
Time Frame: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
|
Body Mass Index (BMI) will be calculated as weight (kg)/height squared (m2).
|
Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
|
|
Waist Circumference
Time Frame: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
|
Waist circumference will be measured at the midway between the iliac crests and the lower ribs.
|
Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer J Salinas, Ph.D., LMSW, University of Texas, El Paso
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Yin Z, Errisuriz VL, Evans M, Inupakutika D, Kaghyan S, Li S, Esparza L, Akopian D, Parra-Medina D. A Digital Health Intervention for Weight Management for Latino Families Living in Rural Communities: Perspectives and Lessons Learned During Development. JMIR Form Res. 2020 Aug 20;4(8):e20679. doi: 10.2196/20679.
- 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.
- 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.
- Tucker JM, Welk GJ, Beyler NK. Physical activity in U.S.: adults compliance with the Physical Activity Guidelines for Americans. Am J Prev Med. 2011 Apr;40(4):454-61. doi: 10.1016/j.amepre.2010.12.016.
- Karstoft K, Clark MA, Jakobsen I, Muller IA, Pedersen BK, Solomon TP, Ried-Larsen M. The effects of 2 weeks of interval vs continuous walking training on glycaemic control and whole-body oxidative stress in individuals with type 2 diabetes: a controlled, randomised, crossover trial. Diabetologia. 2017 Mar;60(3):508-517. doi: 10.1007/s00125-016-4170-6. Epub 2016 Dec 9.
- Bailey MM, Coller RK, Pollack Porter KM. 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Jung J, Cho I. Promoting Physical Activity and Weight Loss With mHealth Interventions Among Workers: Systematic Review and Meta-analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2022 Jan 21;10(1):e30682. doi: 10.2196/30682.
- Muir SD, Silva SSM, Woldegiorgis MA, Rider H, Meyer D, Jayawardana MW. Predictors of Success of Workplace Physical Activity Interventions: A Systematic Review. J Phys Act Health. 2019 Aug 1;16(8):647-656. doi: 10.1123/jpah.2018-0077.
- Salinas JJ, Parra-Medina D. Physical activity change after a promotora-led intervention in low-income Mexican American women residing in South Texas. BMC Public Health. 2019 Jun 20;19(1):782. doi: 10.1186/s12889-019-7105-6.
- Yin Z, Lesser J, Paiva KA, Zapata J Jr, Moreno-Vasquez A, Grigsby TJ, Ryan-Pettes SR, Parra-Medina D, Estrada V, Li S, Wang J. Using Mobile Health Tools to Engage Rural Underserved Individuals in a Diabetes Education Program in South Texas: Feasibility Study. JMIR Mhealth Uhealth. 2020 Mar 24;8(3):e16683. doi: 10.2196/16683.
- Parra-Medina D, Mojica C, Liang Y, Ouyang Y, Ramos AI, Gomez I. Promoting Weight Maintenance among Overweight and Obese Hispanic Children in a Rural Practice. Child Obes. 2015 Aug;11(4):355-63. doi: 10.1089/chi.2014.0120. Epub 2015 May 7.
- Gay JL, Buchner DM. Ethnic disparities in objectively measured physical activity may be due to occupational activity. Prev Med. 2014 Jun;63:58-62. doi: 10.1016/j.ypmed.2014.02.015. Epub 2014 Feb 28.
- Gay JL, Buchner DM, Smith J. Occupational Physical Activity Opposes Obesity: A Cross-Sectional Modern Replication of the Morris 1953 London Busmen Study. J Occup Environ Med. 2019 Mar;61(3):177-182. doi: 10.1097/JOM.0000000000001489.
- Gay JL, Buchner DM, Smith J, He C. An examination of compensation effects in accelerometer-measured occupational and non-occupational physical activity. Prev Med Rep. 2017 Aug 5;8:55-59. doi: 10.1016/j.pmedr.2017.07.013. eCollection 2017 Dec.
- Gay JL, Saunders RP, Rees-Punia E, Dowda M, van den Berg AE. Role of Organizational Support on Implementation of an Environmental Change Intervention to Improve Child Fruit and Vegetable Intake: a Randomized Cross-Over Design. Prev Sci. 2019 Nov;20(8):1211-1218. doi: 10.1007/s11121-019-01043-z.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01MD019289 (U.S. NIH Grant/Contract)
- 7U01MD019289-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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