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临床试验/NCT06411769
NCT06411769
招募中
不适用

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

University of Texas, El Paso1 个研究点 分布在 1 个国家目标入组 406 人2024年9月1日

概览

阶段
不适用
干预措施
50K4LIfe
疾病 / 适应症
Activity Trackers
发起方
University of Texas, El Paso
入组人数
406
试验地点
1
主要终点
Daily Step Count
状态
招募中
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年9月1日
结束日期
2027年6月1日
最后更新
上个月
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

发起方
University of Texas, El Paso
责任方
Sponsor

入排标准

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Phase 1. 50K4LIfe Only

Walking Challenge only

干预措施: 50K4LIfe

Phase 1. 50K4Life + SMS Text Messages

Walking Challenge + SMS Messages

干预措施: 50K4LIfe

Phase 1. 50K4Life + SMS Text Messages

Walking Challenge + SMS Messages

干预措施: SMS Text Messaging

Phase 2. 50K4LIfe + Individual

Walking Challenge + Individual level interventions.

干预措施: 50K4LIfe

Phase 2. 50K4LIfe + Individual

Walking Challenge + Individual level interventions.

干预措施: Individual

Phase 2. 50K4LIfe + School

Walking Challenge + School-level interventions

干预措施: 50K4LIfe

Phase 2. 50K4LIfe + School

Walking Challenge + School-level interventions

干预措施: School

Phase 2. 50K4Life + SMS Text Messages + Individual

Walking Challenge + SMS Messages + Individual level interventions

干预措施: 50K4LIfe

Phase 2. 50K4Life + SMS Text Messages + Individual

Walking Challenge + SMS Messages + Individual level interventions

干预措施: SMS Text Messaging

Phase 2. 50K4Life + SMS Text Messages + Individual

Walking Challenge + SMS Messages + Individual level interventions

干预措施: Individual

Phase 2. 50K4Life + SMS Text Messages + Schools

Walking Challenge + SMS Messages + School-level interventions

干预措施: 50K4LIfe

Phase 2. 50K4Life + SMS Text Messages + Schools

Walking Challenge + SMS Messages + School-level interventions

干预措施: SMS Text Messaging

Phase 2. 50K4Life + SMS Text Messages + Schools

Walking Challenge + SMS Messages + School-level interventions

干预措施: School

Phase 2. Walking Challenge only

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

干预措施: 50K4LIfe

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.

干预措施: 50K4LIfe

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.

干预措施: SMS Text Messaging

结局指标

主要结局

Daily Step Count

时间窗: Daily, Weekly up to 18 months.

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.

次要结局

  • Weight(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.)
  • Height(Baseline)
  • Cardiorespiratory Fitness (CVF)(Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.)
  • Body Mass Index(Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.)

研究点 (1)

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