Virtual Advisors for Physical Activity Promotion in Underserved Communities

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Advisors for Physical Activity Promotion in Underserved Communities

Conditions
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Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Virtual Advisor
* Behavioral: Promotora for physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Promotora for physical activity<br>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<br>* 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.<br>|
| Experimental: Carmen system<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, Intervention, Attitude to Computers