Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411769
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-26
Brief Title:
Evidence-based Intervention to Improve Walking Engagement in El Paso Texas
Sponsor:
University of Texas El Paso
Organization:
University of Texas El Paso
Study Overview
Official Title:
Evidence-based Intervention to Improve Walking Engagement in El Paso Texas
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test if the 50000 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 timeweekend group walkshikes The schools that 50 or more participants who achieve 50000 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
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 timeweekend group walkshikes The schools that 50 or more participants who achieve 50000 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 US-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 US-Mexico border A clustered Sequential Multiple Assignment Randomized Trial SMART will be conducted to determine the effectiveness of an employer-based walking challenge intervention- 50000 for Life 50K4Life- in improving brisk walking engagement at least 7000 stepsday among school district employees The proposed intervention strategies are based on the walking interventions conducted by the Principal Investigators 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 partners 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 US-Mexico border region
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 7U01MD019289-02 | NIH | None | httpsreporternihgovquickSearch7U01MD019289-02 |