Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas

Physical Activity Clinical Trial

Official title:

Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411769
• Other study ID #: U01MD019289
• Secondary ID: 7U01MD019289-02
• Status: Recruiting
• Phase: N/A
• Start date: August 2025
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: University of Texas, El Paso
• Contact: Jennifer J Salinas, Ph.D.,LMSW
• Phone: 915-747-7292
• Email: jsalinas7[@]utep.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activity Trackers
• Physical Activity

Intervention

Behavioral:
• 50K4LIfe
This intervention will consist of the Walking Challenge only.
• SMS Text Messaging
In this intervention, participants will received notifications onto the Pathverse app
• Individual
In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.
• School
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.

Locations

Country	Name	City	State
United States	University of Texas at El Paso	El Paso	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas, El Paso	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Step Count	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	Cardiorespiratory Fitness (CVF)	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.
Secondary	Weight	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.
Secondary	Height	Height (measured to the nearest 0.1 cm) will be obtained using a stadiometer.	Baseline
Secondary	Body Mass Index	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.
Secondary	Waist Circumference	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.