Clinical trial NCT02111213: Virtual Advisors for Physical Activity Promotion in Underserved Communities
Official title: Virtual Advisors for Physical Activity Promotion in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: physical activity
Intervention
Attitude to Computers
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-04-11
Enrollment: 245
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Total Weekly Walking Minutes From Baseline to 12 Months
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Change in Sedentary Behavior From Baseline to 12 Months
timeFrame: baseline, 12 months
measure: Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Prevention Research Center
state: California
Study officials:
affiliation: Stanford University
name: Abby C King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King AC, Campero MI, Sheats JL, Castro Sweet CM, Hauser ME, Garcia D, Chazaro A, Blanco G, Banda J, Ahn DK, Fernandez J, Bickmore T. Effects of Counseling by Peer Human Advisors vs Computers to Increase Walking in Underserved Populations: The COMPASS Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1481-1490. doi: 10.1001/jamainternmed.2020.4143.
citation: King AC, Campero I, Sheats JL, Castro Sweet CM, Garcia D, Chazaro A, Blanco G, Hauser M, Fierros F, Ahn DK, Diaz J, Done M, Fernandez J, Bickmore T. Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics. Contemp Clin Trials. 2017 Oct;61:115-125. doi: 10.1016/j.cct.2017.07.020. Epub 2017 Jul 22.