Virtual Advisors for Physical Activity Promotion in Underserved Communities (COMPASS2)
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|ClinicalTrials.gov Identifier: NCT02111213|
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : October 18, 2019
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sedentary Lifestyle||Behavioral: Virtual Advisor Behavioral: Promotora for physical activity||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The primary study design (involving 245 randomized participants) was a 2-arm non-inferiority randomized trial comparing the effects of physical activity advice delivered by human advisors vs. a computer-based advisor|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Virtual Advisors for Physical Activity Promotion in Underserved Communities|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
Active Comparator: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
- 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)
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111213
|United States, California|
|Stanford Prevention Research Center|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Abby C King, PhD||Stanford University|