ベータ
治験レーダーAI
治験 NCT06411769(対象:Activity Trackers、身体活動)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
フィルター基準に一致する試験が1件見つかりました
タイル表示

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

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06411769介入研究 臨床試験 で、Activity Trackers、身体活動 に関するものです。現在は 募集中 で、2025年8月1日 から開始しています。406 名の参加者 の募集が計画されています。この治験は University of Texas, El Paso によって主催され、2027年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年3月28日 です。
概要
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.

詳細説明
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.
公式タイトル

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

疾患/病気
Activity Trackers身体活動
刊行物
この臨床試験について発表された科学記事と研究論文:
もっと見る
その他の研究識別子
NCT番号
開始日
2025-08
最終更新日
2025-03-28
終了予定日
2027-06
目標参加者数
406
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Walking Challenge
Moderate-to-Vigorous-Physical Activity
Evidence-based
Employer-based
主目的
予防
割付方法
無作為化
介入モデル
逐次割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
実験的Phase 1. 50K4LIfe Only
Walking Challenge only
50K4LIfe
This intervention will consist of the Walking Challenge only.
実験的Phase 1. 50K4Life + SMS Text Messages
Walking Challenge + SMS Messages
50K4LIfe
This intervention will consist of the Walking Challenge only.
SMSテキストメッセージ
In this intervention, participants will received notifications onto the Pathverse app
実験的Phase 2. 50K4LIfe + Individual
Walking Challenge + Individual level interventions.
50K4LIfe
This intervention will consist of the Walking Challenge only.
Individual
In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.
実験的Phase 2. 50K4LIfe + School
Walking Challenge + School-level interventions
50K4LIfe
This intervention will consist of the Walking Challenge only.
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.
実験的Phase 2. 50K4Life + SMS Text Messages + Individual
Walking Challenge + SMS Messages + Individual level interventions
50K4LIfe
This intervention will consist of the Walking Challenge only.
SMSテキストメッセージ
In this intervention, participants will received notifications onto the Pathverse app
Individual
In this Phase 2 individual-level intervention, participants will receive remote education modules and one-to-one monthly phone-based coaching.
実験的Phase 2. 50K4Life + SMS Text Messages + Schools
Walking Challenge + SMS Messages + School-level interventions
50K4LIfe
This intervention will consist of the Walking Challenge only.
SMSテキストメッセージ
In this intervention, participants will received notifications onto the Pathverse app
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.
実験的Phase 2. Walking Challenge only
Participants meeting the step goal in Phase 1(WC only) will continue into Phase 2 without change.
50K4LIfe
This intervention will consist of the Walking Challenge only.
実験的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.
50K4LIfe
This intervention will consist of the Walking Challenge only.
SMSテキストメッセージ
In this intervention, participants will received notifications onto the Pathverse app
主要評価項目
評価指標指標の説明時間枠
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.
副次評価項目
評価指標指標の説明時間枠
Cardiorespiratory Fitness (CVF)
The heart rate/minute at the end of the YMCA 3-minute submaximal bench-stepping test will be used to assess the level of CVF associated with increased PA.
Baseline, 8 weeks, 8 months, 12, months 18 months up to 18 months.
Weight
Weight (to the nearest 0.1 kg) will be collected using a portable scale
Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
Height
Height (measured to the nearest 0.1 cm) will be obtained using a stadiometer.
Baseline
Body Mass Index
Body Mass Index (BMI) will be calculated as weight (kg)/height squared (m2).
Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
Waist Circumference
Waist circumference will be measured at the midway between the iliac crests and the lower ribs.
Baseline, 8 weeks, 8 months, 12 months, 18 months up to 18 months.
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • 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.

  • Works at more than one school
  • Does not work on a district school campus
  • schools that previously participated in walking challenges
University of Texas, El Paso logoUniversity of Texas, El Paso
National Institute on Minority Health and Health Disparities (NIMHD) logoNational Institute on Minority Health and Health Disparities (NIMHD)
試験中央連絡先
連絡先: Jennifer J Salinas, Ph.D.,LMSW, 915-747-7292, [email protected]
連絡先: Kaycee Carmagnani, MSW, 915-747-8349, [email protected]
2 1カ国の場所

Texas

University of Texas at El Paso, El Paso, Texas, 79968, United States
Kaycee Carmagnani, MSW, 連絡先, 915-747-8349, [email protected]
Jennifer J Salinas, Ph.D., LMSW, 研究責任者
募集中
University of Texas at El Paso, El Paso, Texas, 79968, United States
Jennifer Salinas, MSW, 連絡先, 915-747-7292, [email protected]
Jennifer J Salinas, Ph.D., LMSW, 研究責任者
募集中