NCT02111213

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 18, 2019

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

3.9 years

First QC Date

April 2, 2014

Results QC Date

September 20, 2019

Last Update Submit

October 19, 2020

Conditions

Sedentary Lifestyle

Keywords

physical activityInterventionAttitude to Computers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in Sedentary Behavior From Baseline to 12 Months

    baseline, 12 months

  • Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months

    baseline, 12 months

Study Arms (2)

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.

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.

Behavioral: Virtual Advisor

Interventions

Virtual AdvisorBEHAVIORAL

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.

Carmen system
Promotora for physical activityBEHAVIORAL

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.

Promotora for physical activity

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Prevention Research Center

Palo Alto, California, 94304, United States

Location

Related Publications (5)

  • 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.

    PMID: 39987024DERIVED

  • 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.

    PMID: 39044224DERIVED

  • 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.

    PMID: 38766254DERIVED

  • 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.

    PMID: 32986075DERIVED

  • 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.

    PMID: 28739541DERIVED

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Principal Investigator
Organization
Stanford University
desparza@stanford.edu
6507232880

Study Officials

  • Abby C King, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 11, 2014

Study Start

June 1, 2014

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

November 10, 2020

Results First Posted

October 18, 2019

Record last verified: 2020-10

Locations

US(1)