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

NCT ID: NCT06411769

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Activity Trackers Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Phase 1. 50K4LIfe Only

Walking Challenge only

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

Phase 1. 50K4Life + SMS Text Messages

Walking Challenge + SMS Messages

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

SMS Text Messaging

Intervention Type BEHAVIORAL

In this intervention, participants will received notifications onto the Pathverse app

Phase 2. 50K4LIfe + Individual

Walking Challenge + Individual level interventions.

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

Individual

Intervention Type BEHAVIORAL

In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.

Phase 2. 50K4LIfe + School

Walking Challenge + School-level interventions

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

School

Intervention Type BEHAVIORAL

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.

Phase 2. 50K4Life + SMS Text Messages + Individual

Walking Challenge + SMS Messages + Individual level interventions

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

SMS Text Messaging

Intervention Type BEHAVIORAL

In this intervention, participants will received notifications onto the Pathverse app

Individual

Intervention Type BEHAVIORAL

In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.

Phase 2. 50K4Life + SMS Text Messages + Schools

Walking Challenge + SMS Messages + School-level interventions

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

SMS Text Messaging

Intervention Type BEHAVIORAL

In this intervention, participants will received notifications onto the Pathverse app

School

Intervention Type BEHAVIORAL

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.

Phase 2. Walking Challenge only

Participants meeting the step goal in Phase 1(WC only) will continue into Phase 2 without change.

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

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.

Group Type EXPERIMENTAL

50K4LIfe

Intervention Type BEHAVIORAL

This intervention will consist of the Walking Challenge only.

SMS Text Messaging

Intervention Type BEHAVIORAL

In this intervention, participants will received notifications onto the Pathverse app

Interventions

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50K4LIfe

This intervention will consist of the Walking Challenge only.

Intervention Type BEHAVIORAL

SMS Text Messaging

In this intervention, participants will received notifications onto the Pathverse app

Intervention Type BEHAVIORAL

Individual

In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Texas, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer J Salinas, Ph.D., LMSW

Role: PRINCIPAL_INVESTIGATOR

University of Texas, El Paso

Locations

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University of Texas at El Paso

El Paso, Texas, United States

Site Status RECRUITING

University of Texas at El Paso

El Paso, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer J Salinas, Ph.D.,LMSW

Role: CONTACT

915-747-7292

Kaycee Carmagnani, MSW

Role: CONTACT

915-747-8349

Facility Contacts

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Kaycee Carmagnani, MSW

Role: primary

915-747-8349

Jennifer Salinas, MSW

Role: primary

915-747-7292

References

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Other Identifiers

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7U01MD019289-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01MD019289

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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