Sedentary LifestyleCOMPASS2NCT02111213
Virtual Advisors for Physical Activity Promotion in Underserved Communities
A study testing Virtual Advisor and Promotora for physical activity in people with Sedentary Lifestyle, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Virtual Advisor and Promotora for physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Palo Alto, California, 94304
About this study
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.
Read the 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
- Sedentary Lifestyle
- Being tested
- Virtual Advisor, Promotora for physical activity
- Keywords
- physical activity, Intervention, Attitude to Computers
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual AdvisorBehavioural
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 activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Promotora for physical activity |
| 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. Receives: Behavioral: Virtual Advisor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Weekly Walking Minutes From Baseline to 12 Months
Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
Measured: baseline, 12 months
Secondary outcomes (2)
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).
Measured: 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
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2014
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Abby C King, Stanford University
- Investigators
- Abby C King, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111213
- Sponsor's protocol ID
- R01HL116448
- Other IDs
- R01HL116448
- Acronym
- COMPASS2
- Status last verified
- Oct 2020
- First submitted
- 2 Apr 2014
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 41840528Zamora 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.
PubMed 39987024Royer 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.
PubMed 39044224Royer 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.
PubMed 38766254King 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.
PubMed 32986075King 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.
PubMed 28739541
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Advisors for Physical Activity Promotion in Underserved Communities
- ClinicalTrials.gov ID
- NCT02111213
- Acronym / sponsor ID
- COMPASS2 / R01HL116448
- Conditions
- Sedentary Lifestyle
- Keywords
- physical activity, Intervention, Attitude to Computers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Northeastern University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Promotora for physical activity | Active comparator | Behavioral: Promotora for physical activityWeekly 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. |
| Carmen system | Experimental | Behavioral: Virtual AdvisorWeekly 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual 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. | Behavioural | Carmen system |
| Promotora 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. | Behavioural | Promotora for physical activity |
Primary outcome
Change in Total Weekly Walking Minutes From Baseline to 12 Months
Time frame: baseline, 12 months
Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
2 secondary outcomes
Change in Sedentary Behavior From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months
Time frame: baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41840528Zamora 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.
- Derived from this study: PubMed 39987024Zamora 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.
- Derived from this study: PubMed 39044224Royer 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.
- Derived from this study: PubMed 38766254Royer 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.
- Derived from this study: PubMed 32986075King 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.
- Derived from this study: PubMed 28739541King 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.
- The Healthy Aging Research and Technology Solutions Lab at StanfordLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby C King, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Advisor and Promotora for physical activity in people with Sedentary Lifestyle, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Weekly Walking Minutes From Baseline to 12 Months (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111213, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.