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Completed

NCT Number: NCT02111213

Virtual Advisors for Physical Activity Promotion in Underserved Communities

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Prevention Research Center

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Virtual Advisor

Behavioral

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.

Promotora for physical activity

Behavioral

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.

Primary outcomes

  1. Change in Total Weekly Walking Minutes From Baseline to 12 Months

    Time frame: baseline, 12 months

    Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)

Secondary outcomes

  1. Change in Sedentary Behavior From Baseline to 12 Months

    Time frame: 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).

  2. Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months

    Time frame: baseline, 12 months

    moderate to vigorous intensity physical activity as measured by self-report questionnaire

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Acronym: COMPASS2

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2014
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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