Virtual Advisors for Physical Activity Promotion in Underserved Communities

NCT ID: NCT02111213

Last Updated: 2020-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-04-30

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.

Conditions

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Sedentary Lifestyle

Keywords

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physical activity Intervention Attitude to Computers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Promotora for physical activity

Intervention Type BEHAVIORAL

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.

Carmen system

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.

Group Type EXPERIMENTAL

Virtual Advisor

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Abby C King

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abby C King, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Prevention Research Center

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Zamora AN, Campero MI, Garcia DM, Chavez DM, King AC. Acculturation is associated with 12-month adherence to combined MVPA and sedentary behavior guidelines in a sample of midlife and older Latino/a adults: findings from the COMPASS physical activity trial. BMC Public Health. 2025 Feb 22;25(1):737. doi: 10.1186/s12889-025-21885-3.

Reference Type DERIVED
PMID: 39987024 (View on PubMed)

Royer MF, Hauser ME, Zamora AN, Campero MI, Garcia D, Gabaray M, Sheats JL, King AC. Serving up FLAN. a food literacy and nutrition intervention to fend off food insecurity. BMC Nutr. 2024 Jul 23;10(1):102. doi: 10.1186/s40795-024-00909-y.

Reference Type DERIVED
PMID: 39044224 (View on PubMed)

Royer MF, Hauser ME, Zamora AN, Campero MI, Garcia D, Gabaray M, Sheats JL, King AC. Serving Up FLAN. A Food Literacy and Nutrition Intervention to Fend Off Food Insecurity. Res Sq [Preprint]. 2024 May 7:rs.3.rs-4331290. doi: 10.21203/rs.3.rs-4331290/v1.

Reference Type DERIVED
PMID: 38766254 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32986075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28739541 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://healthyaging.stanford.edu

The Healthy Aging Research and Technology Solutions Lab at Stanford

Other Identifiers

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R01HL116448

Identifier Type: NIH

Identifier Source: secondary_id

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R01HL116448

Identifier Type: NIH

Identifier Source: org_study_id

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