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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL116448 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northeastern University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promotora for physical activity | Active Comparator | 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. |
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| Carmen system | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Advisor | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abby C King, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Prevention Research Center | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41840528 | Derived | Zamora AN, Campero MI, Garcia DM, Bickmore T, King AC. Neighborhood context shapes physical activity intervention outcomes: a comparison of human vs. virtual advisors. BMC Public Health. 2026 Mar 16;26(1):1324. doi: 10.1186/s12889-026-26885-5. | |
| 39987024 | Derived | 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. |
| Label | URL |
|---|---|
| The Healthy Aging Research and Technology Solutions Lab at Stanford | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 12-month Change in total minutes per week Per protocol | Posted | Mean | Standard Error | minutes per week | baseline, 12 months |
|
1 year for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | mild leg pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | 6507232880 | desparza@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2019 | Oct 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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
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| Promotora for physical activity | 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. |
|
moderate to vigorous intensity physical activity as measured by self-report questionnaire |
| baseline, 12 months |
| 39044224 | Derived | 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. |
| 38766254 | Derived | 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. |
| 32986075 | Derived | 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. |
| 28739541 | Derived | 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| CHAMPS Physical Activity Questionnaire | Mean | Standard Deviation | total weekly walking minutes |
|
| OG001 | 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. 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. |
|
|
| 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). | Posted | Mean | Standard Error | Minutes per week | 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 | Posted | Mean | Standard Error | minutes per week | baseline, 12 months |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 4 |
| 122 |
| EG001 | 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. 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. | 0 | 123 | 0 | 123 | 3 | 123 |
|
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