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Senior Change Makers Study: Improving Physical Activity Environments

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ClinicalTrials.gov Identifier: NCT02944838
Recruitment Status : Active, not recruiting
First Posted : October 26, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dilip V. Jeste, University of California, San Diego

Brief Summary:
Senior Change Makers is an intergenerational intervention that compares two, 8-week programs: (1) an advocacy program wherein senior participants perform audits of their physical activity environments, identify an advocacy project, and advocate for improvements; and (2) a walking program designed to increase participant physical activity through education and guided walks. The investigators expect that the advocacy program will produce greater improvements in seniors' advocacy skills, confidence, and attitudes at 8 weeks.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Senior Change Makers Advocacy Program Behavioral: Senior Change Makers Physical Activity Program Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Senior Change Makers Study: Improving Physical Activity Environments
Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.).
Behavioral: Senior Change Makers Advocacy Program
see description
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.
Behavioral: Senior Change Makers Physical Activity Program
see description



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Intergenerational attitudes [ Time Frame: 8 weeks ]
    Senior and student participants will complete pre-post survey items to assess changes in intergenerational attitudes and beliefs.

  2. Advocacy actions and outcomes [ Time Frame: 8 weeks and 3 months ]
    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

  3. Physical activity [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944838


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: James Sallis, PhD Distinguished Professor
Principal Investigator: Dilip Jeste, PhD Distinguished Professor

Responsible Party: Dilip V. Jeste, Distinguished Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02944838     History of Changes
Other Study ID Numbers: 160954
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dilip V. Jeste, University of California, San Diego:
older adults
physical activity
built environment