Virtual Advisors for Physical Activity Promotion in Underserved Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Change in Total Weekly Walking Minutes From Baseline to 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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);
- •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);
- •Inability to complete a face-to-face training session with a computer-based program
结局指标
主要结局
Change in Total Weekly Walking Minutes From Baseline to 12 Months
时间窗: baseline, 12 months
Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
次要结局
- Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months(baseline, 12 months)
- Change in Sedentary Behavior From Baseline to 12 Months(baseline, 12 months)
研究者
Abby C King
Professor
Stanford University