CommunicationNCT01144767
Computer-Based Physical Activity Advice for Ethnic Minority Aging Adults
A study testing Computer-generated advisor in people with Communication and Health Behavior, run by Stanford University at 1 site in United States.
Trial summary
Despite the recognized health benefits of a physically active lifestyle, mid-life and older low-income and ethnic minority adults, including Hispanic Americans, are among the least active and understudied groups in the U.S. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Health Behavior, Sedentary Lifestyle
- What is being tested?
- Computer-generated advisor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:1. Spanish or English-speaking Latino men or women 2. Greater than or equal to 55 years of age 3. No plans to move within the next year 4. 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 5. Able to participate in study intervention and assessments at the community-based location 6. Willing to be randomly assigned to either study arm (Year 02) 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, and major functional disabilities in the orthopedic area 2. Not stable on their medications, including hormone replacement therapy, for 3 months 3. Severe depressive symptomatology (score > 16 on the 18-item Spanish version of the Center for Epidemiologic Studies Depression Scale [CES-D]); English version used when indicated 4. Gross levels of dementia (score< 23 on the Folstein Mini-Mental State Exam) 5. Inability to complete a face-to-face training session with the embodied conversational agent (ECA) program
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Despite the recognized health benefits of a physically active lifestyle, mid-life and older low-income and ethnic minority adults, including Hispanic Americans, are among the least active and understudied groups in the U.S. This research aims to develop and evaluate a bi-lingual physical activity promotion program, applying easy to use state-of-the-art computer technology, which is tailored to the preferences and needs of mid-life and older Latino adults. Such computer-based programs represent a potentially low-cost means for reaching the large proportion of low-income and ethnic minority Americans who are under-active.
Read the detailed description
During Phase 1 of this study, the computer program will be adapted to better help Latino older adults to increase physical activity levels. Researchers will conduct focus groups and/or individual interviews to obtain participants feedback used to tailor the program to be appropriate for this population.
During Phase 2, the computer-generated adviser program will be tested to see if it is effective in promoting an increase in physical activity (primarily walking) levels among Latino older adults.
Participants will be randomly assigned to use the computer-generated adviser or to the wait list control group. Participants in the embodied conversational agent (computer-generated adviser) group receive an initial session with a staff health educator to review the expectations and content of this walking program. They will learn how to log onto the computer and interact with the computer adviser using a touch-screen. Participants will interact with the computer adviser at least 3 times per week to report past physical activity (primarily walking) completed, review obstacles (or barriers) to walking, and to set future walking goals. They are also asked to wear a pedometer.
Participants assigned to the wait list will receive an initial session with a staff health educator to review the expectations and content of this program. They will attend a monthly interactive class-based group session lead by a health educator that will cover health-related topics relevant for the older adult such as nutrition, stress management, and brain health. At the end of their involvement with this group they can decide if they want to use the computer adviser program.
Participants of both groups complete physical activity and computer-related questionnaires at the beginning (at 2 months) and at the end of the study (4 months).
- Conditions
- Communication, Health Behavior, Sedentary Lifestyle
- Being tested
- Computer-generated advisor, Comparison control condition
- Medical subject headings
- Communication, Health Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-generated advisorBehavioural
Weekly sessions with a computer generated advisor who offers advice, feedback and guidance on physical activity
Comparison control conditionBehavioural
Weekly/biweekly sessions with a group facilitator to receive health education and information.
| Study group | Role | What they receive |
|---|---|---|
| Computer-generated advisor | Experimental | Participants receive sessions with a computer-generated adviser who will provide tailored advice and encouragement to engage in physical activity. Receives: Behavioral: Computer-generated advisor |
| Comparison control condition | Active comparator | Participants will receive live, group sessions on health topics unrelated to physical activity. Receives: Behavioral: Comparison control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
self-report questionnaire to assess frequency and quantity of physical activity
Measured: 4 months
steps per day measured by accelerometry
objective measure of physical activity collected by accelerometer monitor
Measured: 4 months
Secondary outcomes (4)
physical activity self-efficacy
self-report questionnaire of perceived confidence to engage in physical activity under a variety of circumstances
Measured: 4 months
physical activity decisional balance
self-report questionnaire of perceived pros and cons of engaging in physical activity
Measured: 4 months
Computer Attitude Scale
self-report questionnaire of perceived confidence and anxiety around computers and technology
Measured: 4 months
Working Alliance Inventory
self-report questionnaire of perceptions and attitudes about the working relationship with the advisor
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies 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
- Masking
- Single blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University
- Responsible party
- Principal investigator, Abby C King, Stanford University
- Investigators
- Abby C King, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144767
- Sponsor's protocol ID
- SU-04262010-5762
- Other IDs
- 10894
- Status last verified
- Dec 2015
- First submitted
- 14 Jun 2010
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
King AC, Bickmore TW, Campero MI, Pruitt LA, Yin JL. Employing virtual advisors in preventive care for underserved communities: results from the COMPASS study. J Health Commun. 2013;18(12):1449-64. doi: 10.1080/10810730.2013.798374. Epub 2013 Aug 13.
PubMed 23941610
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Physical Activity Advice for Ethnic Minority Aging Adults
- ClinicalTrials.gov ID
- NCT01144767
- Acronym / sponsor ID
- SU-04262010-5762
- Conditions
- Communication, Health Behavior, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Northeastern University
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the recognized health benefits of a physically active lifestyle, mid-life and older low-income and ethnic minority adults, including Hispanic Americans, are among the least active and understudied groups in the U.S. This research aims to develop and evaluate a bi-lingual physical activity promotion program, applying easy to use state-of-the-art computer technology, which is tailored to the preferences and needs of mid-life and older Latino adults. Such computer-based programs represent a potentially low-cost means for reaching the large proportion of low-income and ethnic minority Americans who are under-active.
Detailed description
During Phase 1 of this study, the computer program will be adapted to better help Latino older adults to increase physical activity levels. Researchers will conduct focus groups and/or individual interviews to obtain participants feedback used to tailor the program to be appropriate for this population.
During Phase 2, the computer-generated adviser program will be tested to see if it is effective in promoting an increase in physical activity (primarily walking) levels among Latino older adults.
Participants will be randomly assigned to use the computer-generated adviser or to the wait list control group. Participants in the embodied conversational agent (computer-generated adviser) group receive an initial session with a staff health educator to review the expectations and content of this walking program. They will learn how to log onto the computer and interact with the computer adviser using a touch-screen. Participants will interact with the computer adviser at least 3 times per week to report past physical activity (primarily walking) completed, review obstacles (or barriers) to walking, and to set future walking goals. They are also asked to wear a pedometer.
Participants assigned to the wait list will receive an initial session with a staff health educator to review the expectations and content of this program. They will attend a monthly interactive class-based group session lead by a health educator that will cover health-related topics relevant for the older adult such as nutrition, stress management, and brain health. At the end of their involvement with this group they can decide if they want to use the computer adviser program.
Participants of both groups complete physical activity and computer-related questionnaires at the beginning (at 2 months) and at the end of the study (4 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-generated advisor | Experimental | Behavioral: Computer-generated advisorParticipants receive sessions with a computer-generated adviser who will provide tailored advice and encouragement to engage in physical activity. |
| Comparison control condition | Active comparator | Behavioral: Comparison control conditionParticipants will receive live, group sessions on health topics unrelated to physical activity. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Computer-generated advisorWeekly sessions with a computer generated advisor who offers advice, feedback and guidance on physical activity | Behavioural | Computer-generated advisor |
| Comparison control conditionWeekly/biweekly sessions with a group facilitator to receive health education and information. | Behavioural | Comparison control condition |
Primary outcome
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Time frame: 4 months
self-report questionnaire to assess frequency and quantity of physical activity
steps per day measured by accelerometry
Time frame: 4 months
objective measure of physical activity collected by accelerometer monitor
4 secondary outcomes
physical activity self-efficacy
Time frame: 4 months
physical activity decisional balance
Time frame: 4 months
Computer Attitude Scale
Time frame: 4 months
Working Alliance Inventory
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Derived from this study: PubMed 23941610King AC, Bickmore TW, Campero MI, Pruitt LA, Yin JL. Employing virtual advisors in preventive care for underserved communities: results from the COMPASS study. J Health Commun. 2013;18(12):1449-64. doi: 10.1080/10810730.2013.798374. Epub 2013 Aug 13.
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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 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 Computer-generated advisor in people with Communication and Health Behavior, 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?
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 9 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT01144767, which also lists 1 linked publication.
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 9 Dec 2015.