Sedentary LifestyleNCT02944838
Senior Change Makers Study: Improving Physical Activity Environments
A study testing Senior Change Makers Advocacy Program and Senior Change Makers Physical Activity Program in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Senior Change Makers Advocacy Program and Senior Change Makers Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to May 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92103
About this study
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.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Senior Change Makers Advocacy Program, Senior Change Makers Physical Activity Program
- Keywords
- older adults, physical activity, built environment
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior Change Makers Advocacy ProgramBehavioural
see description
Senior Change Makers Physical Activity ProgramBehavioural
see description
| Study group | Role | What they receive |
|---|---|---|
| Advocacy | Active comparator | 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.). Receives: Behavioral: Senior Change Makers Advocacy Program |
| Physical Activity | Active comparator | 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. Receives: Behavioral: Senior Change Makers Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advocacy skills and beliefs
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
Measured: 8 weeks
Secondary outcomes (3)
Intergenerational attitudes
Senior and student participants will complete pre-post survey items to assess changes in intergenerational attitudes and beliefs.
Measured: 8 weeks
Advocacy actions and outcomes
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
Measured: 8 weeks and 3 months
Physical activity
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017
- Study completionMay 2018
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 Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilip V. Jeste, University of California, San Diego
- Investigators
- James Sallis, PhD, Principal investigator, Distinguished ProfessorDilip Jeste, PhD, Principal investigator, Distinguished Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944838
- Sponsor's protocol ID
- 160954
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Patch CM, Conway TL, Kerr J, Arredondo EM, Levy S, Spoon C, Butte KJ, Sannidhi D, Millstein RA, Glorioso D, Jeste DV, Sallis JF. Engaging older adults as advocates for age-friendly, walkable communities: The Senior Change Makers Pilot Study. Transl Behav Med. 2021 Sep 15;11(9):1751-1763. doi: 10.1093/tbm/ibab098.
PubMed 34293156
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senior Change Makers Study: Improving Physical Activity Environments
- ClinicalTrials.gov ID
- NCT02944838
- Acronym / sponsor ID
- 160954
- Conditions
- Sedentary Lifestyle
- Keywords
- older adults, physical activity, built environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 Oct 2016 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advocacy | Active comparator | Behavioral: Senior Change Makers Advocacy ProgramThe 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.). |
| Physical Activity | Active comparator | Behavioral: Senior Change Makers Physical Activity ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Senior Change Makers Advocacy Programsee description | Behavioural | Advocacy |
| Senior Change Makers Physical Activity Programsee description | Behavioural | Physical Activity |
Primary outcome
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
3 secondary outcomes
Intergenerational attitudes
Time frame: 8 weeks
Advocacy actions and outcomes
Time frame: 8 weeks and 3 months
Physical activity
Time frame: 8 weeks
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 10 Oct 2018.
- Derived from this study: PubMed 34293156Patch CM, Conway TL, Kerr J, Arredondo EM, Levy S, Spoon C, Butte KJ, Sannidhi D, Millstein RA, Glorioso D, Jeste DV, Sallis JF. Engaging older adults as advocates for age-friendly, walkable communities: The Senior Change Makers Pilot Study. Transl Behav Med. 2021 Sep 15;11(9):1751-1763. doi: 10.1093/tbm/ibab098.
- Individual participant dataSharing planned: No
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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.
James Sallis, PhD principal investigator
Distinguished Professor
Dilip Jeste, PhD principal investigator
Distinguished Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior Change Makers Advocacy Program and Senior Change Makers Physical Activity Program in people with Sedentary Lifestyle, run by University of California, San Diego 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?
The sponsor lists 8 inclusion and 11 exclusion criteria. 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 10 Oct 2018. 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?
Advocacy skills and beliefs (time frame: 8 weeks). 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 NCT02944838, 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 10 Oct 2018.