Computer-Based Physical Activity Advice for Ethnic Minority Aging Adults

Health Behavior Clinical Trial

Official title:

Computer-Based Physical Activity Advice for Ethnic Minority Aging Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144767
• Other study ID #: SU-04262010-5762
• Secondary ID: 10894
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: December 8, 2015
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: December 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communication
• Health Behavior
• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire	self-report questionnaire to assess frequency and quantity of physical activity	4 months	No
Primary	steps per day measured by accelerometry	objective measure of physical activity collected by accelerometer monitor	4 months	No
Secondary	physical activity self-efficacy	self-report questionnaire of perceived confidence to engage in physical activity under a variety of circumstances	4 months	No
Secondary	physical activity decisional balance	self-report questionnaire of perceived pros and cons of engaging in physical activity	4 months	No
Secondary	Computer Attitude Scale	self-report questionnaire of perceived confidence and anxiety around computers and technology	4 months	No
Secondary	Working Alliance Inventory	self-report questionnaire of perceptions and attitudes about the working relationship with the advisor	4 months	No