NCT06411769

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Sep 2024Jun 2027

First Submitted

Initial submission to the registry

April 26, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

April 26, 2024

Last Update Submit

March 12, 2026

Conditions

Keywords

Walking ChallengeModerate-to-Vigorous-Physical ActivityEvidence-basedEmployer-based

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Cardiorespiratory Fitness (CVF)

    Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.

  • Weight

    Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.

  • Height

    Baseline

  • Body Mass Index

    Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.

  • Waist Circumference

    Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.

Study Arms (8)

Phase 1. 50K4LIfe Only

EXPERIMENTAL

Walking Challenge only

Behavioral: 50K4LIfe

Phase 1. 50K4Life + SMS Text Messages

EXPERIMENTAL

Walking Challenge + SMS Messages

Behavioral: 50K4LIfeBehavioral: SMS Text Messaging

Phase 2. 50K4LIfe + Individual

EXPERIMENTAL

Walking Challenge + Individual level interventions.

Behavioral: 50K4LIfeBehavioral: Individual

Phase 2. 50K4LIfe + School

EXPERIMENTAL

Walking Challenge + School-level interventions

Behavioral: 50K4LIfeBehavioral: School

Phase 2. 50K4Life + SMS Text Messages + Individual

EXPERIMENTAL

Walking Challenge + SMS Messages + Individual level interventions

Behavioral: 50K4LIfeBehavioral: SMS Text MessagingBehavioral: Individual

Phase 2. 50K4Life + SMS Text Messages + Schools

EXPERIMENTAL

Walking Challenge + SMS Messages + School-level interventions

Behavioral: 50K4LIfeBehavioral: SMS Text MessagingBehavioral: School

Phase 2. Walking Challenge only

EXPERIMENTAL

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

Behavioral: 50K4LIfe

Phase 2. Walking Challenge + SMS Text Messages

EXPERIMENTAL

Participants meeting their step goal in Phase 1 (WC + SMS Text Messages) will continue into Phase 2 without change.

Behavioral: 50K4LIfeBehavioral: SMS Text Messaging

Interventions

50K4LIfeBEHAVIORAL

This intervention will consist of the Walking Challenge only.

Phase 1. 50K4LIfe OnlyPhase 1. 50K4Life + SMS Text MessagesPhase 2. 50K4LIfe + IndividualPhase 2. 50K4LIfe + SchoolPhase 2. 50K4Life + SMS Text Messages + IndividualPhase 2. 50K4Life + SMS Text Messages + SchoolsPhase 2. Walking Challenge + SMS Text MessagesPhase 2. Walking Challenge only

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

Phase 1. 50K4Life + SMS Text MessagesPhase 2. 50K4Life + SMS Text Messages + IndividualPhase 2. 50K4Life + SMS Text Messages + SchoolsPhase 2. Walking Challenge + SMS Text Messages
IndividualBEHAVIORAL

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

Phase 2. 50K4LIfe + IndividualPhase 2. 50K4Life + SMS Text Messages + Individual
SchoolBEHAVIORAL

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 + SchoolPhase 2. 50K4Life + SMS Text Messages + Schools

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Works at more than one school
  • Does not work on a district school campus
  • schools that previously participated in walking challenges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas at El Paso

El Paso, Texas, 79968, United States

RECRUITING

University of Texas at El Paso

El Paso, Texas, 79968, United States

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Motor Activity

Interventions

Schools

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

  • Jennifer J Salinas, Ph.D., LMSW

    University of Texas, El Paso

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer J Salinas, Ph.D.,LMSW

CONTACT

Kaycee Carmagnani, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 13, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations