Clinical Trials Directory

Trials / Completed

CompletedNCT02111213

Virtual Advisors for Physical Activity Promotion in Underserved Communities

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
245 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALVirtual AdvisorThe virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity.
BEHAVIORALPromotora for physical activityA 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.

Timeline

Start date
2014-06-01
Primary completion
2018-04-30
Completion
2018-04-30
First posted
2014-04-11
Last updated
2020-11-10
Results posted
2019-10-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02111213. Inclusion in this directory is not an endorsement.