Virtual Advisors for Physical Activity Promotion in Underserved Communities

Not Applicable

Completed

• Conditions: Sedentary Lifestyle
• Interventions: Behavioral: Virtual Advisor; Behavioral: Promotora for physical activity

• Registration Number: NCT02111213
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-11
• Study Start: 2014-06
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Results First Submitted: 2019-09-20
• Results First Submitted QC: 2019-10-16
• Results First Posted: 2019-10-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carmen system	Virtual Advisor	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.
Promotora for physical activity	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.

Primary Outcome Measures

Name	Time	Method
Change in Total Weekly Walking Minutes From Baseline to 12 Months	baseline, 12 months	Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)

Secondary Outcome Measures

Name	Time	Method
Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months	baseline, 12 months	moderate to vigorous intensity physical activity as measured by self-report questionnaire
Change in Sedentary Behavior From Baseline to 12 Months	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).

Trial Locations

Locations (1)

Stanford Prevention Research Center; 🇺🇸 Palo Alto, California, United States