Sedentary Lifestyle
Conditions
Keywords
physical activity, Intervention, Attitude to Computers
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.
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.
Interventions
BEHAVIORALVirtual 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.
BEHAVIORALPromotora 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.
Sponsors
Northeastern University
National Heart, Lung, and Blood Institute (NHLBI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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 advisor
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 122 |
| 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. | 123 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Promotora for Physical Activity | Carmen System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical >=65 years | 30 Participants | 29 Participants | 59 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 94 Participants | 186 Participants |
| Age, Continuous | 62.4 years STANDARD_DEVIATION 8.5 | 63.1 years STANDARD_DEVIATION 8.3 | 62.8 years STANDARD_DEVIATION 8.4 |
| CHAMPS Physical Activity Questionnaire | 80.2 total weekly walking minutes STANDARD_DEVIATION 109.3 | 59.6 total weekly walking minutes STANDARD_DEVIATION 84.4 | 70.0 total weekly walking minutes STANDARD_DEVIATION 98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 121 Participants | 120 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 122 Participants | 120 Participants | 242 Participants |
| Region of Enrollment United States | 122 participants | 123 participants | 245 participants |
| Sex: Female, Male Female | 95 Participants | 98 Participants | 193 Participants |
| Sex: Female, Male Male | 27 Participants | 25 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 123 |
| other Total, other adverse events | 4 / 122 | 3 / 123 |
| serious Total, serious adverse events | 0 / 122 | 0 / 123 |
Outcome results
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)
Time frame: baseline, 12 months
Population: 12-month Change in total minutes per week Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promotora for Physical Activity | Change in Total Weekly Walking Minutes From Baseline to 12 Months | 134.8 minutes per week | Standard Error 18 |
| Carmen System | Change in Total Weekly Walking Minutes From Baseline to 12 Months | 158.6 minutes per week | Standard Error 20.1 |
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
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promotora for Physical Activity | Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months | 105.4 minutes per week | Standard Error 13.9 |
| Carmen System | Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months | 103.4 minutes per week | Standard Error 16.2 |
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).
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promotora for Physical Activity | Change in Sedentary Behavior From Baseline to 12 Months | -251.9 Minutes per week | Standard Error 110 |
| Carmen System | Change in Sedentary Behavior From Baseline to 12 Months | -272.1 Minutes per week | Standard Error 121 |