- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02944838
Senior Change Makers Study: Improving Physical Activity Environments
Study Overview
Status
Conditions
Detailed Description
The proposed study will be conducted at six senior centers in San Diego, California and will involve 132 senior participants, 16 student participants, and 12 decision maker participants (N = 160). Three senior centers will be randomized to an advocacy program and three will be randomized to a walking program.
The participants at the advocacy intervention sites will undergo an 8-week advocacy program during which they will (1) learn about the connection between the built environment and physical activity, (2) conduct a field audit of their physical activity environment using the Microscale Audit of Pedestrian Streetscapes (MAPS) Mini tool, (3) select an advocacy issue related to a physical activity barrier, and (4) engage in advocacy actions, such as communicating with decision makers or public officials. The group sessions will include topics such as how the environment affects walking, potential pedestrian hazards and solutions, how to conduct an audit of the walking environment, what advocates do, local examples of successful advocacy projects, creating an advocacy action plan, creating a fact sheet about the advocacy issue, writing letters to representatives, making an advocacy presentation. The student participants will work with the senior participants throughout the program to help accomplish the advocacy goals. The program will culminate with the presentation of the advocacy issue to a "decision maker" (e.g., a city planner, engineer, city council member, etc.).
In the other study condition, the walking groups, participants will undergo an 8-week program that provides participants with information about safe physical activity, strategies to increase physical activity, and guided walks. The group sessions will address topics such as the benefits of walking, fall prevention tips, goal setting, positive thinking, social support, sedentary behavior and health, barriers to walking, handling setbacks, and overcoming challenges to physical activity. Comparing two beneficial programs helps with participant recruitment and retention, and ensures that between-group differences in outcomes are not due solely to participation in a group program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92103
- University of California, San Diego
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 50 years or older
- have not had a fall that resulted in a hospitalization in the past 12 months
- able to walk 3 meters within 30 seconds (Shumway-Cook, et al., 2000)
- able to walk without human assistance (cane or walker use okay)
- able to read and write in English
- able to complete written surveys without assistance
- able to attend regular study activities at the center
- able to provide written informed consent
Exclusion Criteria:
- Older adult participants will be excluded if they:
- are younger than 50 years
- have had a fall that resulted in a hospitalization in the last 12 months
- cannot complete the walking test within 30 seconds
- are not able to read and write in English
- are not able to complete written surveys without assistance
- cannot regularly attend study activities at the center
- are not willing to complete study activities
- are not willing to complete study assessment and wear the activity meter
- are not able to provide written informed consent
- cannot walk without human assistance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Advocacy
The Senior Change Makers Advocacy Program consists of weekly meetings, 1 hour each, for 8-weeks.
The program will be led by graduate level students and will address topics such as how the environment affects walking, potential pedestrian hazards and solutions, how to conduct an audit of the walking environment, what advocates do, local examples of successful advocacy projects, creating an advocacy action plan, creating a fact sheet about the advocacy issue, writing letters to representatives, and making an advocacy presentation.
The program will culminate with the presentation of the advocacy issue to a "decision maker" (e.g., a city planner, engineer, city council member, etc.).
|
see description
|
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Active Comparator: Physical Activity
The Senior Change Makers Physical Activity Program consists of weekly meetings, 1 hour each, for 8 weeks.
The program provides participants with information about safe physical activity, strategies to increase physical activity, and guided walks.
Topics will focus on walking, but we will also include information and activities relating to strength training, flexibility, and balance.
Behavioral skills such as goal setting, addressing barriers, and social support will also be addressed.
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see description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Advocacy skills and beliefs
Time Frame: 8 weeks
|
The investigators will use validated survey items to measure seniors' changes in self-efficacy for advocacy, perceived socio-political control, and assertiveness (Millstein, 2013).
Sample item: "I am confident that I can work to make my community a better place for being physically active."
These are key outcomes of the advocacy training
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intergenerational attitudes
Time Frame: 8 weeks
|
Senior and student participants will complete pre-post survey items to assess changes in intergenerational attitudes and beliefs.
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8 weeks
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Advocacy actions and outcomes
Time Frame: 8 weeks and 3 months
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The investigators will measure completion of advocacy "actions" and "outcomes" with a checklist survey taken by the researchers.
Examples of actions include testimony, letters, and meetings.
To determine if decision makers took any action after the advocacy, the investigators will ask the decision makers or their staff to complete a short, 10-minute survey, after the advocacy action.
The survey will solicit feedback for the advocates, assess whether any action occurred, and assess the decision makers' perceptions of the advocacy and study.
Researchers will follow-up again at 3 months to assess completion of advocacy actions, if the decision makers took any actions, and whether any changes occurred
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8 weeks and 3 months
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Physical activity
Time Frame: 8 weeks
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Physical activity will be measured at baseline and after completion of the 8-week intervention.
The investigators will use Actigraph accelerometers (model GT3X, Pensacola, FL), set to collect data in 60 second epochs to match cut points.
Senior participants will wear the accelerometer for seven days during all waking hours (except when bathing or swimming) and estimates of physical activity levels and sedentary time will be calculated using validated algorithms and cut points for seniors.
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8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: James Sallis, PhD, Distinguished Professor
- Principal Investigator: Dilip Jeste, PhD, Distinguished Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 160954
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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