COMPASS2: Virtual Advisors for Physical Activity Promotion in Underserved Communities

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02111213
• Collaborator: Northeastern University (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 245
• Location: 1
• Arms: 2
• Actual Duration (Months): 46.9
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sedentary Lifestyle	Behavioral: Virtual Advisor; Behavioral: Promotora for physical activity	N/A

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

• Study Type: Interventional
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 advisorThe 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 (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Virtual Advisors for Physical Activity Promotion in Underserved Communities
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Total Weekly Walking Minutes From Baseline to 12 Months [baseline, 12 months]

   Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)

Secondary Outcome Measures

1. Change in Sedentary Behavior From Baseline to 12 Months [baseline, 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).

2. Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months [baseline, 12 months]

   moderate to vigorous intensity physical activity as measured by self-report questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Prevention Research Center	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University
• Northeastern University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Abby C King, PhD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 30, 2019

More Information

Additional Information:

• The Healthy Aging Research and Technology Solutions Lab at Stanford

Publications

None provided.

• Responsible Party: Abby C King, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02111213
• Other Study ID Numbers: R01HL116448; R01HL116448
• First Posted: Apr 11, 2014
• Last Update Posted: Nov 10, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Abby C King, Professor, Stanford University: physical activity; Intervention; Attitude to Computers

Study Results

Participant Flow

Arm/Group Title	Promotora for Physical Activity	Carmen System
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	122	123
COMPLETED	116	117
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	Promotora for Physical Activity	Carmen System	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	122	123	245
Age (Count of Participants)
<=18 years	NA NaN	NA NaN	NA NaN
Between 18 and 65 years	92 75.4%	94 76.4%	186 75.9%
>=65 years	30 24.6%	29 23.6%	59 24.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.4 (8.5)	63.1 (8.3)	62.8 (8.4)
Sex: Female, Male (Count of Participants)
Female	95 77.9%	98 79.7%	193 78.8%
Male	27 22.1%	25 20.3%	52 21.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	121 99.2%	120 97.6%	241 98.4%
Not Hispanic or Latino	1 0.8%	3 2.4%	4 1.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	3 2.4%	3 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	122 100%	120 97.6%	242 98.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	122 100%	123 100%	245 100%
CHAMPS Physical Activity Questionnaire (total weekly walking minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [total weekly walking minutes]	80.2 (109.3)	59.6 (84.4)	70.0 (98.0)

Outcome Measures

1. Primary Outcome

Title	Change in Total Weekly Walking Minutes From Baseline to 12 Months
Description	Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
Time Frame	baseline, 12 months

Outcome Measure Data

Analysis Population Description

12-month Change in total minutes per week Per protocol

Arm/Group Title	Promotora for Physical Activity	Carmen System
Arm/Group Description	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.	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.
Measure Participants	114	117
Mean (Standard Error) [minutes per week]	134.8 (18.0)	158.6 (20.1)

2. Secondary Outcome

Title	Change in Sedentary Behavior From Baseline to 12 Months
Description	Self-reported time spent in the following activities: watching television, computer use, reading, socializing, transport and hobbies, and a summary measure (total sedentary time).
Time Frame	baseline, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Promotora for Physical Activity	Carmen System
Arm/Group Description	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.	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.
Measure Participants	122	123
Mean (Standard Error) [Minutes per week]	-251.9 (110.0)	-272.1 (121.0)

3. Secondary Outcome

Title	Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months
Description	moderate to vigorous intensity physical activity as measured by self-report questionnaire
Time Frame	baseline, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Promotora for Physical Activity	Carmen System
Arm/Group Description	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.	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.
Measure Participants	122	123
Mean (Standard Error) [minutes per week]	105.4 (13.9)	103.4 (16.2)

Adverse Events

Time Frame	1 year for each participant
Arm/Group Title	Promotora for Physical Activity		Carmen System
Arm/Group Description	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.		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.
All Cause Mortality
	Promotora for Physical Activity		Carmen System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/123 (0%)
Serious Adverse Events
	Promotora for Physical Activity		Carmen System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Promotora for Physical Activity		Carmen System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/122 (3.3%)		3/123 (2.4%)
Musculoskeletal and connective tissue disorders
leg pain	4/122 (3.3%)	4	3/123 (2.4%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.