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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
Sponsor:
Collaborators:
Northeastern University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Abby C King, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Virtual Advisor Behavioral: Promotora for physical activity Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford Prevention Research Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Northeastern University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Abby C King, PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Abby C King, Stanford University:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abby C King, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02111213    
Other Study ID Numbers: R01HL116448 ( U.S. NIH Grant/Contract )
R01HL116448 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2014    Key Record Dates
Results First Posted: October 18, 2019
Last Update Posted: November 10, 2020
Last Verified: October 2020
Keywords provided by Abby C King, Stanford University:
physical activity
Intervention
Attitude to Computers