Trial Outcomes & Findings for Virtual Advisors for Physical Activity Promotion in Underserved Communities (NCT NCT02111213)

NCT ID: NCT02111213

Last Updated: 2020-11-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 245 participants
• Primary outcome timeframe: baseline, 12 months
• Results posted on: 2020-11-10

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	122	123
Overall Study COMPLETED	116	117
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

Virtual Advisors for Physical Activity Promotion in Underserved Communities

Baseline characteristics by cohort

Measure	Promotora for Physical Activity n=122 Participants 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.	Carmen System n=123 Participants 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 n=245 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants	94 Participants n=7 Participants	186 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Age, Continuous	62.4 years STANDARD_DEVIATION 8.5 • n=5 Participants	63.1 years STANDARD_DEVIATION 8.3 • n=7 Participants	62.8 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	98 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	121 Participants n=5 Participants	120 Participants n=7 Participants	241 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants	120 Participants n=7 Participants	242 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	123 participants n=7 Participants	245 participants n=5 Participants
CHAMPS Physical Activity Questionnaire	80.2 total weekly walking minutes STANDARD_DEVIATION 109.3 • n=5 Participants	59.6 total weekly walking minutes STANDARD_DEVIATION 84.4 • n=7 Participants	70.0 total weekly walking minutes STANDARD_DEVIATION 98.0 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 months

Population: 12-month Change in total minutes per week Per protocol

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

Outcome measures

Measure	Promotora for Physical Activity n=114 Participants 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.	Carmen System n=117 Participants 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.
Change in Total Weekly Walking Minutes From Baseline to 12 Months	134.8 minutes per week Standard Error 18.0	158.6 minutes per week Standard Error 20.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Promotora for Physical Activity n=122 Participants 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.	Carmen System n=123 Participants 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.
Change in Sedentary Behavior From Baseline to 12 Months	-251.9 Minutes per week Standard Error 110.0	-272.1 Minutes per week Standard Error 121.0

SECONDARY outcome

Timeframe: baseline, 12 months

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

Outcome measures

Measure	Promotora for Physical Activity n=122 Participants 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.	Carmen System n=123 Participants 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.
Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months	105.4 minutes per week Standard Error 13.9	103.4 minutes per week Standard Error 16.2

Adverse Events

Promotora for Physical Activity

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Carmen System

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Promotora for Physical Activity n=122 participants at risk 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.	Carmen System n=123 participants at risk 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.
Musculoskeletal and connective tissue disorders leg pain	3.3% 4/122 • Number of events 4 • 1 year for each participant	2.4% 3/123 • Number of events 3 • 1 year for each participant

Additional Information

Principal Investigator

Stanford University

Phone: 6507232880

Email: desparza@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place