Expired Study
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Stanford, California 94305


Purpose:

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.


Study summary:

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).


Criteria:

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


Study is Available At:


Original ID:

SU-04262010-5762


NCT ID:

NCT01144767


Secondary ID:

10894


Study Acronym:


Brief Title:

Computer-Based Physical Activity Advice for Ethnic Minority Aging Adults


Official Title:

Computer-Based Physical Activity Advice for Ethnic Minority Aging Adults


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

55 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Abby C King
Principal Investigator
Stanford University

Study Dates

Start Date:November 2008
Completion Date:April 2010
Completion Type:Actual
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 8, 2015
First Received Date:June 14, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Time Frame:4 months
Safety Issues:False
Description:self-report questionnaire to assess frequency and quantity of physical activity
Outcome Type:Primary Outcome
Measure:steps per day measured by accelerometry
Time Frame:4 months
Safety Issues:False
Description:objective measure of physical activity collected by accelerometer monitor
Outcome Type:Secondary Outcome
Measure:physical activity self-efficacy
Time Frame:4 months
Safety Issues:False
Description:self-report questionnaire of perceived confidence to engage in physical activity under a variety of circumstances
Outcome Type:Secondary Outcome
Measure:physical activity decisional balance
Time Frame:4 months
Safety Issues:False
Description:self-report questionnaire of perceived pros and cons of engaging in physical activity
Outcome Type:Secondary Outcome
Measure:Computer Attitude Scale
Time Frame:4 months
Safety Issues:False
Description:self-report questionnaire of perceived confidence and anxiety around computers and technology
Outcome Type:Secondary Outcome
Measure:Working Alliance Inventory
Time Frame:4 months
Safety Issues:False
Description:self-report questionnaire of perceptions and attitudes about the working relationship with the advisor

Study Interventions

Intervention Type:Behavioral
Name:Computer-generated advisor
Description:Weekly sessions with a computer generated advisor who offers advice, feedback and guidance on physical activity
Arm Name:Computer-generated advisor
Intervention Type:Behavioral
Name:Comparison control condition
Description:Weekly/biweekly sessions with a group facilitator to receive health education and information.
Arm Name:Comparison control condition

Study Arms

Study Arm Type:Active Comparator
Arm Name:Comparison control condition
Description:Participants will receive live, group sessions on health topics unrelated to physical activity.
Study Arm Type:Experimental
Arm Name:Computer-generated advisor
Description:Participants receive sessions with a computer-generated adviser who will provide tailored advice and encouragement to engage in physical activity.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Northeastern University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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