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Virtual Advisors for Physical Activity Promotion in Underserved Communities (COMPASS2)

2020年10月19日 更新者：Abby C King、Stanford University
The primary aim of this research study is to evaluate the effectiveness of a computer-based 'virtual lay advisor' intervention relative to a proven human lay advisor/promotore intervention to promote regular walking among inactive midlife and older Latino adults. The primary analysis is a non-inferiority analysis comparing these two interventions.

研究概览

地位

完全的

条件

干预/治疗

详细说明

COMPASS (Computerized Physical Activity Support for Seniors) was a single-blind, cluster-randomized noninferiority parallel trial conducted by investigators from Stanford University School of Medicine and Northeastern University. Participants were recruited from community centers in Santa Clara and San Mateo Counties, CA which had been randomized in pairs based on locale to either Virtual or Human advisors. Allocation concealment was accomplished by utilizing staff not directly involved in study enrollment, assessment, or intervention procedures. Both arms received a similar 12-month behavioral PA instruction/support program at their designated community center based on Active Choices-an individually-tailored PA intervention with demonstrated effectiveness and translatability across diverse adult populations. The primary outcome was change in 12-month weekly walking minutes.

In addition to the major trial and primary investigation described above, an exploratory Substudy was conducted separately to begin to evaluate the initial "proof of concept" of a food literacy curriculum in 2 separate community centers that were not part of the major trial. This first-generation exploratory Substudy is not part of the major trial and therefore is not included in this protocol and trial description.

研究类型

介入性

注册 (实际的)

245

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94304
        • Stanford Prevention Research Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Spanish or English-speaking primarily Latino men or women
  • Aged greater than or equal to 50 years
  • No plans to move within the next year
  • Inactive (have not engaged in moderate-intensity or more vigorous physical activity
  • > 3 days per week for at least 20 min per day) within last 6 months
  • Able to participate in study intervention and assessments at their local neighborhood senior center

Exclusion Criteria:

  1. Any medical condition or disorder that would limit participation in moderate intensity physical activity (such as sustained walking), including life-threatening disorders, myocardial ischemia, major functional disabilities in the orthopedic area, or inability to complete baseline assessments for any reason (including psychological, cognitive);
  2. Not stable on their medications, including hormone replacement therapy, for ≥ 3 months (given that changes in medications can create additional stress and burden over and above attempts to change lifestyle behaviors);
  3. Inability to complete a face-to-face training session with a computer-based program

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Promotora for physical activity
Weekly sessions with a volunteer promotora at a community center. A promotora is a trained, lay health worker. The promotora will provide guidance, advice and support to participants to encourage them to be more physically active.
行为的：Promotora for physical activity
A promotora is a trained, lay health worker. Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active. They work with people face to face and by telephone to offer support and advice.
实验性的：Carmen system
Weekly sessions with the virtual advisor accessed through a computer located at a community center. Carmen is the virtual advisor and will provide guidance, advice and support to participants to encourage them to be more physically active.
行为的：Virtual Advisor
The virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Total Weekly Walking Minutes From Baseline to 12 Months
大体时间：baseline, 12 months
Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
baseline, 12 months

次要结果测量

结果测量
措施说明
大体时间
Change in Sedentary Behavior From Baseline to 12 Months
大体时间：baseline, 12 months
Self-reported time spent in the following activities: watching television, computer use, reading, socializing, transport and hobbies, and a summary measure (total sedentary time).
baseline, 12 months
Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months
大体时间：baseline, 12 months
moderate to vigorous intensity physical activity as measured by self-report questionnaire
baseline, 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

合作者

National Heart, Lung, and Blood Institute (NHLBI)
Northeastern University

调查人员

  • 首席研究员：Abby C King, PhD、Stanford University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年6月1日

初级完成 (实际的)

2018年4月30日

研究完成 (实际的)

2018年4月30日

研究注册日期

首次提交

2014年4月2日

首先提交符合 QC 标准的

2014年4月8日

首次发布 (估计)

2014年4月11日

研究记录更新

最后更新发布 (实际的)

2020年11月10日

上次提交的符合 QC 标准的更新

2020年10月19日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • R01HL116448 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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