Clinical trial NCT06411769: Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas
Official title: Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Activity Trackers
Physical Activity
Keywords: Walking Challenge
Moderate-to-Vigorous-Physical Activity
Evidence-based
Employer-based
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-05-13
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily Step Count
timeFrame: Daily, Weekly up to 18 months.
Secondary outcomes:
measure: Cardiorespiratory Fitness (CVF)
timeFrame: Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.
measure: Weight
timeFrame: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
measure: Height
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
measure: Waist Circumference
timeFrame: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University of Texas at El Paso
state: Texas
city: El Paso
country: United States
facility: University of Texas at El Paso
state: Texas
Study officials:
affiliation: University of Texas, El Paso
name: Jennifer J Salinas, Ph.D., LMSW
role: PRINCIPAL_INVESTIGATOR
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