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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 50K4LIfe
  This intervention will consist of the Walking Challenge only.
• Поведенческое SMS Text Messaging
  In this intervention, participants will received notifications onto the Pathverse app
• Поведенческое Individual
  In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.
• Поведенческое 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.

Первичные конечные точки

• Daily Step Count [Срок оценки: Daily, Weekly up to 18 months.]

Вторичные конечные точки (5)

• Cardiorespiratory Fitness (CVF) [Срок оценки: Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.]
• Weight [Срок оценки: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.]
• Height [Срок оценки: Baseline]
• Body Mass Index [Срок оценки: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.]
• Waist Circumference [Срок оценки: Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• University of Texas at El Paso — El Paso
• University of Texas at El Paso — El Paso

Публикации

• Parra-Medina D, Hilfinger Messias DK. Promotion of Physical Activity Among Mexican-Origin Women in Texas and South Carolina: An Examination of Social, Cultural, Economic, and Environmental Factors. Quest. 2011 Feb;63(1):100-117. doi: 10.1080/00336297.2011.10483668. PMID 21731409
• Tucker JM, Welk GJ, Beyler NK. Physical activity in U.S.: adults compliance with the Physical Activity Guidelines for Americans. Am J Prev Med. 2011 Apr;40(4):454-61. doi: 10.1016/j.amepre.2010.12.016. PMID 21406280
• Karstoft K, Clark MA, Jakobsen I, Muller IA, Pedersen BK, Solomon TP, Ried-Larsen M. The effects of 2 weeks of interval vs continuous walking training on glycaemic control and whole-body oxidative stress in individuals with type 2 diabetes: a controlled, randomised, crossover trial. Diabetologia. 2017 Mar;60(3):508-517. doi: 10.1007/s00125-016-4170-6. Epub 2016 Dec 9. PMID 27942800
• Bailey MM, Coller RK, Pollack Porter KM. A qualitative study of facilitators and barriers to implementing worksite policies that support physical activity. BMC Public Health. 2018 Sep 27;18(1):1145. doi: 10.1186/s12889-018-6045-x. PMID 30261871
• Garne-Dalgaard A, Mann S, Bredahl TVG, Stochkendahl MJ. Implementation strategies, and barriers and facilitators for implementation of physical activity at work: a scoping review. Chiropr Man Therap. 2019 Oct 9;27:48. doi: 10.1186/s12998-019-0268-5. eCollection 2019. PMID 31624537
• Sedani A, Stover D, Coyle B, Wani RJ. Assessing Workplace Health and Safety Strategies, Trends, and Barriers through a Statewide Worksite Survey. Int J Environ Res Public Health. 2019 Jul 11;16(14):2475. doi: 10.3390/ijerph16142475. PMID 31336749
• Wu S, Fisher-Hoch SP, Reninger B, McCormick JB. Meeting or Exceeding Physical Activity Guidelines is Associated with Reduced Risk for Cancer in Mexican-Americans. Am J Cancer Prev. 2016;4(1):1-7. doi: 10.12691/ajcp-4-1-1. Epub 2016 Jan 29. PMID 28529961
• Salinas JJ, Valenzuela R, Sheen J, Carlyle M, Gay J, Morales A. An ORBIT Phase 1: Design study of a citywide employer-based walking challenges in a predominantly Mexican American metropolitan area. J Health Psychol. 2022 Mar;27(4):961-973. doi: 10.1177/1359105320977650. Epub 2020 Dec 20. PMID 33345634

Идентификаторы

NCT: NCT06411769 · U01MD019289 · 7U01MD019289-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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