Virtual Advisors for Physical Activity Promotion in Underserved Communities

Sedentary Lifestyle Clinical Trial

— COMPASS2  

Official title:

Virtual Advisors for Physical Activity Promotion in Underserved Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111213
• Other study ID #: R01HL116448
• Secondary ID: R01HL116448
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 30, 2018

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford Prevention Research Center	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   The Healthy Aging Research and Technology Solutions Lab at Stanford